FDA
Home Page | CDRH Home Page | Search
| CDRH
A-Z Index | Contact CDRH
|
|
|
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) |
||||||||
|
||||||||
FDA
Releases Class II Special Controls Guidance Document for “Endotoxin
Assay" (November 4, 2003) |
||||||||
|
||||||||
Misys
Healthcare Issues Domestic and International Recall of Misys Laboratory,
a Laboratory Information System Software Device (October 22, 2003) |
||||||||
Media Inquiries: 301-827-6242 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: 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:
|
||||||||
ISO
15197 standard recognized for use in evaluating performance for home
glucose meters (July 15, 2003) |
||||||||
|
||||||||
FDA
has developed a draft guidance document for coagulation test systems
(July 14, 2003) |
||||||||
|
||||||||
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) |
||||||||
|
||||||||
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) |
||||||||
|
||||||||
Read Document | ||||||||
Database
for Home Use Lab Tests, also known as Over-The-Counter (OTC) Tests
is now available (June 19, 2003) |
||||||||
|
||||||||
Search Database | ||||||||
FDA
releases Draft Guidance for Industry and FDA Reviewers "Multiplex
Tests for Heritable DNA Markers, Mutations and Expression Patterns" (May 1, 2003) |
||||||||
|
||||||||
Read Press Release | ||||||||
Roche
Issues Urgent Product Correction for the Accu-Chek Comfort Curve and
Accu-Chek Advantage Glucose Test Strips (April 3, 2003) |
||||||||
|
||||||||
FDA
Draft Guidance - "Statistical Guidance on Reporting Results from
Studies Evaluating Diagnostic Tests" (March 12, 2003) |
||||||||
|
||||||||
Read Guidance | ||||||||
Webcast
- "Introducing FDA's New Office of In Vitro Diagnostic Devices."
(originally aired 2/19/03) |
||||||||
|
||||||||
View Webcast | ||||||||
Roche Issues
Alert About False Expiration Dates on Imported Advantage II Glucose
Test Strips. (February 1, 2003) |
||||||||
|
||||||||
Read Dear Healthcare Provider Letter |
Updated August 31, 2004
CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page
Center for Devices and Radiological Health / CDRH