American Association for Clinical Chemistry
Better health through laboratory medicine
April 2010 Clinical Laboratory News: News from the FDA

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April 2010: Volume 36, Number 4 

Tensions Rise in Buildup to IOM Report on FDA 510(k) Process

Although not due out until 2011, the forthcoming report on FDA’s 510(k) regulatory process from IOM is already raising the pressure on the agency from both sides in the debate, as test and device manufacturers worry about more demanding regulation while others within and without FDA push for more dramatic changes. Both FDA and IOM recently held public meetings to discuss the fate of 510(k)s, and FDA officials hinted at their meeting that they were not going to wait for the IOM report to start tweaking the 30-year-old program that reviews upwards of 90% of tests and devices on the market.

Representing manufacturers whose tests and devices fall under the purview of the 510(k) system, also known as premarket notification, the Advanced Medical Technology Association (AdvaMed) released a statement saying that it hopes the IOM analysis will “underscore the strengths of FDA’s current regulatory approach.” AdvaMed pointed out that while the 510(k) system has been characterized as a “fast track” for moderate- and low-risk tests and devices, FDA considers specifications and performance testing information, including, in many cases, clinical data, before the agency determines whether a device can be made available for patients, and that the length of review is determined by FDA and based on potential impact to public health and on technological complexity.

Among other issues, FDA officials spoke extensively at their public meeting about how predicate devices are used in the current regulatory scheme. These are the tests or devices to which a manufacturer must prove “substantial equivalence” as part of 510(k) review. FDA noted that companies sometimes reference a “lowest common denominator device” as the predicate. To improve the system, the agency said it will consider releasing data about cleared devices and try to eliminate the use of very outdated devices as predicates.

An archived video webcast of the FDA meeting is available from the FDA website.

Calibration Verifiers Cleared

DiaSorin announced FDA clearance for its LIAISON N-TACT PHT calibration verifiers. The calibration verifier set is a four-level control set which can be used to meet CLIA requirements for calibration verification in labs. The set is intended for use in the quantitative verification of calibration of reportable range when performed on the LIAISON analyzer. The set is not intended for use as routine quality control materials or as calibration materials.

FDA Approves Anti-HBs Assay

Ortho Clinical Diagnostics announced approval of its VITROS Anti-HBs assay. The approval is for revision of the intended use to include use of the VITROS 5600 Integrated System and VITROS 3600 Immunodiagnostic System with the VITROS Immunodiagnostic Products Anti-HBs Assay. The assay is indicated for the quantitative in vitro determination of total antibody to hepatitis B surface antigen (anti-HBs) in human serum using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System. Assay results may be used as an aid in the determination of susceptibility to hepatitis B virus (HBV) infection for individuals prior to or following HBV vaccination, or where vaccination status is unknown. Assay results may be used with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection.