January 2010 Clinical Laboratory News: News from the FDA

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January 2009: Volume 36, Number 1

ARK Diagnostics’ Levetiracetam Assay Cleared

ARK Diagnostics received FDA 510(k) clearance for its ARK Levetiracetam Assay to be used as an aid in managing patients treated with Levetiracetam, an anti-convulsant drug for epilepsy. The assay is intended to quantitatively determine levels of Levetiracetam in human serum or plasma on automated clinical chemistry analyzers. The results obtained from this assay can be used to diagnose and treat Levetiracetam overdose, as well as to monitor therapeutic levels of the drug.

ARKAY Glucose Monitor Cleared

ARKAY received FDA 510(k) clearance for its new GLUCOCARD Vital blood glucose monitoring system. The GLUCOCARD Vital meter and strip platform holds 250 downloadable tests in its memory and has a glucose oxidase strip not affected by interferences that cause testing errors.

Roche Receives EUA for Influenza Assay

FDA granted an emergency use authorization (EUA) to Roche for its RealTime ready Influenza A/H1N1 Detection Set for use in the detection of the 2009 H1N1 influenza virus. In conjunction with Roche’s RealTime ready RNA Virus Master kit, the set detects RNA from the 2009 H1N1 virus for rapid identification of patients infected with the virus. The assay is designed for the Roche MagNA Pure LC platform for nucleic acid isolation and the LightCycler 2.0 system for real-time PCR. Under the current EUA, Roche can provide the set to CLIA high-complexity labs for the duration of the declared H1N1-related public health emergency.

CellaVision Blood Analyzer Granted FDA Clearance

CellaVision received FDA clearance to sell and market its new blood analyzer in the U.S. The CellaVision DM1200 is a fully automated analyzer intended to replace manual microscopy of blood samples, increasing workflow in medium-sized hospitals. Already available in Europe and Canada, the analyzer is expected to be available to customers in the U.S. by the first quarter of 2010. Sysmex America will distribute the system in the U.S.

Nanosphere OK’d for H1N1 Assay Updates

FDA 510(k) clearance was granted to Nanosphere to update packaging inserts for its Verigene Respiratory Virus Nucleic Acid Test on the Verigene SP System (RVNATSP). The insert will now indicate the test’s reactivity with influenza A in cultured clinical isolates containing the 2009 H1N1 influenza virus. Although shown to detect the 2009 H1N1 influenza virus in cultured isolates, the performance characteristics with patient specimens positive for the 2009 H1N1 influenza virus have not been established. FDA cleared the RVNATSP assay in October 2009 for the differential diagnosis of influenza A, influenza B, and respiratory syncytial virus infections.

Clarification: H1N1 Tests

In the December 2009 issue of CLN, our reports, FDA Grants Second Authorization for Focus Diagnostics’ H1N1 Test and Gen-Probe Granted FDA EUA for Flu Test, presented conflicting information.

To clarify, Focus Diagnostics and Roche are the only companies offering H1N1 influenza virus test kits that have emergency use authorization (EUA) from the FDA. Labs that perform the test must be certified as a CLIA high-complexity lab. However, the Prodesse ProFlu-ST test by Gen-Probe did receive FDA EUA for use in CLIA high-complexity labs for the diagnosis of the 2009 H1N1 influenza virus in patients who have already been diagnosed with influenza A by an FDA-cleared or authorized device. The Focus Diagnostics Simplexa Influenza A H1N1 (2009) test uses a real-time PCR to qualitatively detect RNA of the H1N1 virus, whereas the Prodesse ProFlu-ST test is aided by an algorithm that relies on seasonal A/H1 and A/H3 results. The Focus Diagnostics Simplexa Influenza A H1N1 (2009) test does not need to be used in conjunction with an FDA-cleared device.

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