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OIVD News


This section lists current & archived OIVD news.

 
FDA and CMS invite the CEOs of Laboratory Corp. of America and Quest Diagnostics to discuss the nature and appropriate regulatory status of the OvaCheck - Ovarian Cancer Screen Test
(March 5, 2004)

In a letter to the Chairman and CEO of the Laboratory Corporation of America and a letter to the CEO of Quest Diagnostics, the Food and Drug Administration and Centers for Medicare and Medicaid Services stated that the markting status of the OvaCheck, a new test for ovarian cancer screening, is unclear. The two agencies have invited each of these laboratories to come in for discussion of whether this new assay would be subject to regulation only by CMS, under the Clinical Laboratories Improvement Amendments of 1988 (CLIA), or whether it may also require premarket review by FDA under the Federal Food, Drug, and Cosmetic Act. Both agencies are anxious to work with the involved stakeholders to ensure a properly validated test is rapidly available to the medical marketplace.

Quest Diagnostics Letter | Lab Corporation of American Letter
 
FDA Clears the West Nile Virus IgM Capture ELISA and the West Nile Virus ELISA IgG Tests Manufactured by Focus Technologies.
(November 13, 2003)

On October 22, 2003 the Food and Drug Administration (FDA) approved two more tests for use as an aid in the clinical laboratory diagnosis of West Nile Virus infection. The two tests, the West Nile Virus IgM Capture ELISA and the West Nile Virus ELISA IgG are serological assays made by Focus Technologies in Cypress, California. They are intended for use in patients with clinical signs and symptoms consistent with meningioencephalitis. To see the Decision Summary for these tests go to K031952 and K031953

The disease caused by West Nile virus first appeared in 1999 in New York City. Since then the West Nile virus has spread rapidly across the United States with 44 states reporting over 7000 human cases to the CDC for the year 2003.

West Nile virus is a flavivirus that is transmitted to humans by mosquito bites. Most people who are infected with West Nile virus (WNV) will not have any type of illness. Experts estimate that 20% of the people who become infected will develop West Nile fever: mild symptoms, including fever, headache, and body aches, occasionally with a skin rash on the trunk of the body and swollen lymph glands. The most serious manifestation of this disease is meningitis or encephalitis (inflammation of the brain). Encephalitis occurs in less than 1% of those infected, causing severe neurological disease and even death.

The Focus West Nile Virus IgM and IgG assays were evaluated using over 1000 retrospective and prospectively collected patient sera, which were tested at four different clinical sites. When compared to the reference testing methods (Plaque-Reduction Neutralization Test or the CDC ELISA assays) the serological performance was satisfactory. Overall agreement rates with the reference methods for the Focus IgM assay was 97.3% and 92.7% for the Focus IgG assay. The sensitivities and specificities varied depending on the populations studied and the comparative methods used.

While the test is an aid in diagnosis of West Nile virus, there is extensive cross-reactivity with other known flavivirus including St. Louis encephalitis virus, and dengue virus. Some significant cross-reactivity has been noted with the Focus IgG assay and antibodies from other agents such as cytomegalovirus and La Crosse virus and rheumatoid factor sometimes cross-reacted with the Focus IgM assay. Positive results therefore are presumptive and must be confirmed by Plaque Reduction Neutralization Test (PRNT), or by using the current CDC guidelines for diagnosis of this disease

IgM antibodies to West Nile virus usually can be detected within the first 1 to 8 days after onset of overt disease and can assist in the diagnosis of these patients. IgG antibodies to West Nile are detected a little later and persist longer than IgM antibodies. The results from the Focus West Nile Virus IgM and IgG assays, when used in conjunction, may be able to distinguish a past West Nile virus or flavivirus infection from a current or recent infection. These two tests will contribute in helping to identify and deal with the growing public health problem concerning human infection with the West Nile virus.

 
FDA Recognizes Two New IVD Standards Developed by NCCLS - The MM7-A and M33-A.
(November 13, 2003)

FDA recognized the following two standards developed by the National Committee for Clinical Laboratory Standards.

NCCLS, MM7-A, Fluorescence In Situ Hybridization (FISH) Methods for Medical Genetics; Approved Guideline

NCCLS, M33-A, Antiviral Susceptibility Testing: Herpes Simplex Virus by Plaque Reduction Assay; Approved Standard

 
FDA Releases Draft Guidance Document on “Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use"
(November 4, 2003)

The 10/28/03 Federal Register announced the availability of the draft guidance entitled "Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use". You can view this document at: http://www.fda.gov/cdrh/ocd/guidance/4444.html This document provides guidance on the use of selected symbols in place of text to convey some of the information required for IVDs intended for professional use by FDA's labeling requirements for IVDs.

 
FDA Releases Class II Special Controls Guidance Document for “Serological Reagents for the Laboratory Diagnosis of West Nile Virus''
(November 4, 2003)


The 10/30/03 Federal Register announced classification of the West Nile Virus IgM Capture Elisa assay. The Agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. You can view this document at: http://www.fda.gov/cdrh/oivd/guidance/1206.html

 
FDA Releases Class II Special Controls Guidance Document for “Endotoxin Assay"
(November 4, 2003)


The 10/31/03 Federal Register announced classification of the Endotoxin Assay. The Agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. You can view this document at: http://www.fda.gov/cdrh/oivd/guidance/1222.html

 
Misys Healthcare Issues Domestic and International Recall of Misys Laboratory, a Laboratory Information System Software Device
(October 22, 2003)

Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA

October 10, 2003

Misys Healthcare Systems of Tucson, Ariz., is initiating a domestic and international recall of the Misys Laboratory software version 5.3. Version 5.3 of the software has demonstrated a defect could result when the information systems uses 3 specific functions together,i.e. Rapid Order, Calculations, and Autofiling. The use of the defective laboratory information system software could result in the release of laboratory test reports without quality assurance validation and without abnormal results flags for critical values and abnormal results. To date no injuries have been reported in connection with this problem. FDA has been made aware of the recall and is working with the company.

The recalled products have been distributed to health care facilities throughout the world. Misys Healthcare Systems is notifying its customers and strongly advising that the health care institutions using this product request the individual code correction package B-AUT-RAPID-LAB as soon as possible.

Such requests should be made to the Misys Client Advocate at 1-877-239-6337. European clients may call 44 (0) 161 335 0562.

 
OIVD is posting on this web page a Summary of how Decisions were made to clear a 510(k) submission
(October 3, 2003)
Consistent with CDRH’s center-wide “Knowledge Management” and “Transparency” initiatives, the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) has implemented the use of a standardized Decision Summary Template in which, at a glance, one can understand the basis for clearance of a particular 510(k) submission. This program has been in place since August 1, 2003.

To see these Decision Summaries for all 510(k) clearances since August 1, 2003, go to the following link from the OIVD home page:
Cleared/Approved OIVD Products Since 8/1/2003

Select any of the products from the list of the cleared products by clicking on the Device’s name. This function will take you to the 510(k) Premarket Notification Database. By scrolling down you will see Decision Summary (Word Document) link. By clicking on the link you will see the Decision Summary Template that explains the basis for clearance of that particular device.

Please note that you may also see a Statement or a Summary link. These two documents are different from the FDA Decision Summary in that they are prepared by the manufacturer of the device, and not the FDA.

 
Roche Diagnostics Recalls All CoaguChek PT Test Strips Currently in the Marketplace
(September 30, 2003)
National recall notice on medical device used to determine blood clotting time (issued September 26, 2003)

Roche Diagnostics is notifying users of an important recall of all CoaguChek PT test strips currently in the market place because of the potential for a packaging defect that will cause false results.

CoaguChek PT test strips are used by patients in the home and by professionals in medical settings to determine blood clotting time of patients taking anti-coagulants, also known as blood thinners, and to diagnose some disease conditions. Incorrect results may have serious or life threatening consequences because patients may be improperly diagnosed or improperly treated. Blood thinners are used to treat patients with a potential for blood clots. For example, patients with heart valve replacement, certain types of heart disease or blood clots in their legs.

Roche has determined that some of the foil pouches in which the test strips are packaged were improperly sealed allowing moisture and air to enter the pouch. These products give false results when exposed to moisture for more than a few minutes. Home users should contact their health care professional for further advice and instructions.

Roche Diagnostics is notifying all home users and health care professionals who use the product to inspect the foil pouch prior to use and to perform duplicate testing for all lots until further notice. The problem is the perforation and the “easy open” notches are not properly centered between the pouches. Users must inspect each pouch prior to use, not use any strips from that box if they see a defect, and run two test strips each time they test in case they fail to visually detect the defect.

Investigations reveal that only a small percentage of the strips are affected. There have been no reports of illnesses or injuries resulting from a pouch defect.

Letters are being sent to customers, providers, and physicians, informing them of this voluntary action. Additional information, including a photograph of the defective pouch, will be posted on Roche Diagnostics’ U.S. CoaguChek Web site at: http://www.coaguchek-usa.com.

US customers with immediate concerns, or interested in details of this recall, can call Roche Diagnostics Point of Care Technical Service at: 1-800-428-4674.

Roche Diagnostics has implemented corrective actions to resolve this issue. This action is being taken by Roche Diagnostics with the knowledge of the U.S. Food and Drug Administration.

For more information contact:

Lori LeRoy
Joel Reuter
Roche Diagnostics Corporation
Roche Diagnostics Corporation
317-521-7159
317-521-7431
Lori.leroy@roche.com
Joel.reuter@roche.com
 
ISO 15197 standard recognized for use in evaluating performance for home glucose meters
(July 15, 2003)

ISO (the International Organization for Standardization) 15197 standard has recently been recognized for use in evaluating performance for home glucose meters.  This standard sets up a protocol for performance measurement and also defines error limits.  While FDA plans to recognize this standard in the future, like all voluntary standards, it is non-binding for the purposes of premarket review.  FDA plans to work on clarified labeling and communication of performance information so that users will better understand how well a particular glucose meter will perform under specified conditions.

 
FDA has developed a draft guidance document for coagulation test systems
(July 14, 2003)

FDA has developed a draft guidance document to assist industry in preparing premarket notification submissions [510(k)s] for the instrument component of laboratory-based coagulation test system(s). The guidance document identifies the classification regulations and product codes for the coagulation analyzers. It lists the risks to health identified by FDA and describes measures that, if followed by manufacturers and combined with the general controls, will generally address the risks associated with these coagulation analyzers and lead to a timely 510(k) review and clearance. This document supplements other FDA documents regarding the specific content requirements of a 510(k) submission.

Read Document
 
Guidance document on quality assurance (QA) practices for sites using the OraQuick® Rapid HIV-1 Antibody Test is now available
(July 14, 2003)

This document provides guidance on quality assurance (QA) practices for sites using or planning to use the OraQuick® Rapid HIV-1 Antibody Test to detect antibodies to the human immunodeficiency virus (HIV). The OraQuick Rapid HIV-1 Antibody Test is the first rapid HIV point-of-care (i.e., testing and results are available in one visit) test approved by the Food and Drug Administration (FDA). It is also the first test for HIV that the FDA has waived under the Clinical Laboratory Improvement Amendment regulations (CLIA). The OraQuick test uses whole blood obtained from puncture of a finger. Results are available within 20 to 60 minutes. Positive results with the OraQuick rapid test are preliminary, however, and must be followed up with an acceptable confirmatory test. Although the OraQuick test device is simple to use and can provide reliable results when the manufacturer’s directions are followed, mistakes can occur at any point in the testing process. To reduce mistakes and to ensure that the FDA restrictions for sale of the test are followed, a site must have a QA program in place before offering OraQuick testing. The guidelines in this document outline the basic parts of a QA program.

Read Document
 
FDA is required to post on the Internet the list of class I and II devices we have exempted from 510(k), and to update the Internet posting within 30 days of any revision of the list
(June 19, 2003)

Section 211 of the Medical Device User Fee and Modernization Act (MDUFMA) amends 510(m)(1) to require FDA to post on the Internet the list of class II devices we have exempted from 510(k), and to update the Internet posting within 30 days of any revision of the list. These same procedures are applied for the list of class I devices we have exempted.

Read Document
 
Database for Home Use Lab Tests, also known as Over-The-Counter (OTC) Tests is now available
(June 19, 2003)

A database of Home Use Lab Tests [Over-the-Counter tests (OTC)] and collection kits that have been cleared or approved by the FDA is now available for use.

Search Database
 
FDA releases Draft Guidance for Industry and FDA Reviewers "Multiplex Tests for Heritable DNA Markers, Mutations and Expression Patterns"
(May 1, 2003)

FDA released a new draft guidance for industry and CDRH reviewers entitled “ Multiplex Tests for Heritable DNA Markers, Mutations and Expression Patterns”. The draft guidance was published in the Federal Register on Monday, April 21. This document, authored by Dr. Elizabeth Mansfield in OIVD’s Division of Microbiology, provides guidance on preparing and reviewing premarket approval (PMA) submissions for multiplex tests, or tests that assay multiple analytes simultaneously. This guidance primarily considers nucleic acid based analysis such as oligonucleotide, cDNA, but many of the principles apply to protein and tissue arrays as well. A period of 90 days is allowed for comment on this draft guidance

Read Press Release
 
Roche Issues Urgent Product Correction for the Accu-Chek Comfort Curve and Accu-Chek Advantage Glucose Test Strips
(April 3, 2003)

Roche Diagnostics Corporation has issued an urgent product correction to all chain and independent pharmacies, diabetes health care providers and laboratory managers in hospitals that have purchased these Accu-Chek products. The urgent product correction alerts them to the possibility of cracks in the bottom of Accu-Chek Comfort Curve and Accu-Chek Advantage blood glucose test strip vials. Roche has confirmed that this vial defect will cause erroneously low or high blood glucose readings and that the cracks in the vial may develop at any time, including after the vial has been opened. The cracks in the vials appear to be due to vial manufacturing issues.

Roche is requesting that users be advised to inspect the bottom of every vial for cracks before each use. Users are further instructed not to use the test strips from a cracked vial. If a crack is not observed and blood glucose results are unusually high, low, or inconsistent, users are instructed by Roche to repeat the test and run a quality control check.

Roche has asked all notified pharmacist(s) and physician’s offices to notify their patients of this urgent product correction. This product correction refers to all lots currently available of the Accu-Chek Comfort Curve test strips, part numbers 2030420, 2030365, 2030373, 2030381, 3000133, 3000141 and the Accu-Chek Advantage test strips, part numbers 336, 553, 787, and 966.

 
FDA Draft Guidance - "Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests"
(March 12, 2003)

FDA released a new draft guidance for industry and CDRH reviewers entitled "Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests.” The draft guidance was published in the Federal Register on Wednesday, March 12. This document, authored by Dr. Kristen Meier in OSB's Division of Biostatistics, discusses some statistically valid approaches for reporting results from evaluation of studies of new diagnostic devices. It also identifies some common inappropriate practices. Special attention is given to describing a practice called discrepant resolution and its associated problems. A period of 90 days is allowed for comment on this draft guidance.

Read Guidance
 
Webcast - "Introducing FDA's New Office of In Vitro Diagnostic Devices."
(originally aired 2/19/03)

This webcast introduced the Office of In Vitro Diagnostic Device Evaluation and Safety, a new component of FDA's Center for Devices and Radiological Health. Senior FDA officials in the new Office described why the Office was established, and outlined its structure. They were joined by representatives of the in vitro diagnostics industry and discussed the advantages the new organization can offer manufacturers, what the industry can expect from this new Office, and what the Office will expect from industry.

View Webcast
 
Roche Issues Alert About False Expiration Dates on Imported Advantage II Glucose Test Strips.
(February 1, 2003)

Roche Diagnostics Corporation has alerted healthcare providers that some lots of Advantage II test strips, which are intended solely for distribution outside of the U.S., have been repackaged and reimported into the U.S. as Accu-Chek® Comfort Curve® test strips, in some cases with altered expiration dates. These lots were never distributed in the U.S. and are not cleared for sale in the U.S. by the FDA. Problems with these test strips include: incorrect expiration dates, improper calibration for U.S. glucose meters, and questionable product performance due to unknown storage or handling conditions by the importer.

Read Dear Healthcare Provider Letter

Archived OIVD News

   
  • July 19, 2004
FDA grants CLIA waiver for the use of oral fluid specimens with the OraQuick ADVANCE Rapid HIV-1/2 Antibody Test.
  • June 28, 2004
FDA approved a new test to help diagnose fungal infections
  • June 28, 2004
NCI/FDA Workshop: Research Srtategies, Study Designs and Statistical Approaches to Biomarkers Validation for Cancer Diagnosis and Detection
  • June 23, 2004
FDA requested that manufacturers of commercial antimicrobial susceptibility test devices take specific actions to minimize the risk of failing to reliably detect vancomycin resistant S. aureus (VRSA)
More Information
  • June 7, 2004
FDA Approves the First Serum Antibody Test for Diagnosis of Anthrax
  • June 7, 2004
Ortho-Clinical Diagnostics Initiates a Voluntary Nationwide Class I Recall of 4 lots of the VITROS Troponin Test
  • May 24, 2004
FDA classifies the voluntary Roche Molecular Systems COBAS TaqMan and TaqMan 48 Analyzers recall as a Class I recall
  • May 11, 2004
OIVD issued Class II Special Controls Guidance Document: Immunomagnetic Circulating Cancer Cell Selection and Enumeration System for Industry and FDA Staff
  • May 6, 2004
FDA issues draft guidance for Industry titled Combination Products, Timeliness of Premarket Reviews: Dispute Resolution Guidance
  • May 4, 2004
FDA Clears the CellSearch™ Epithelial Cell Kit / CellSpotter™ Analyzr used in monitoring patients undergoing breast cancer treatment to indicate treatment effectiveness.
  • March 26, 2004
FDA Approves First Oral Fluid Based Rapid HIV Test Kit
  • March 19, 2004
bioMèrieux, Inc. Recalls the VITEK GPS-107 Gram Positive Susceptibility Card, lot M83X and FDA Classifies this Voluntary Action as a Class I Recall
  • March 18, 2004
FDA Recommends that Ventana Medical Systems Inc. Submit a Premarket Approval Application (PMA) for Their Marketed Automated INFORM® Human Papillomavirus (HPV) In-Situ Hybridization (ISH) Diagnostic Test System
  • March 16, 2004
FDA Issues Class II Special Controls Guidance Document for Factor V Leiden DNA Mutation Detection Systems
  • March 9, 2004
FDA Law Allows for Electronic Labeling if Users May Still Request Labeling in Paper Form
  • March 5, 2004
FDA and CMS invite the CEOs of Laboratory Corp. of America and Quest Diagnostics to discuss the nature and appropriate regulatory status of the OvaCheck - Ovarian Cancer Screen Test
Quest Diagnostics Letter | Lab Corporation of American Letter
  • February 27, 2004
FDA Releases Version of New Database - Devices@FDA
  • February 24, 2004
Abbott laboratories Inc. issues a letter to customers regarding counterfeit packaging of Precision QID Blood Glucose Test Strips
  • February 12, 2004
FDA approves the DakoCytomation EGFR pharmDx™ test used to identify colorectal cancer patients eligible for treatment with the cancer drug, ERBITUX™ (cetuximab).
  • February 4, 2004
FDA requests the seizure of various neonatal chemistry and isoelectric focusing diagnostic kits at PerkinElmer Life Sciences, Inc., in Norton, Ohio
  • December 18, 2003
FDA issues letter to Abbott Laboratories regarding conformity with the Quality System Regulation, 21 CFR Part 820.
  • December 17, 2003
OIVD clears the first DNA-based laboratory tests for detection of genetic abnormalities in Factor V Leiden and Factor II (prothrombin) genes.
  • December 11, 2003
FDA releases Replacement Reagent and Instrument Family Guidance document
  • December 9, 2003
FDA Clears the Readline Alert test to identify culture grown Bacillus anthracis, the bacteria that causes Anthrax disease
  • December 2, 2003
FDA Updates and Clarifies Draft Guidance to Industry on Drug of Abuse Screening Tests
  • July 28, 2003
FDA Clears New Diabetes Device for Marketing
  • July 28, 2003
FDA Clears First Test for West Nile Virus
  • June 19, 2003
FDA cleared the Platelia Aspergillus EIA test for marketing. This is the first rapid laboratory test for a life-threatening invasive fungal infection, Aspergillosis
  • April 1, 2003
FDA Approves Expanded Use of HPV Test
  • February 14, 2003
FDA Clears New Lab Test to Help Rule Out Heart Attack
  • February 11, 2003
FDA Clears Lab Test to Diagnose Latent Tuberculosis Infections
  • January 31, 2003
HHS Extends Use of Rapid HIV Test to New Sites Nationwide

Updated August 31, 2004

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