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DiaSorin, Roche, Inova Diagnostics Receive FDA 510(k) Clearances in February

NEW YORK ─ The US Food and Drug Administration in February granted 510(k) clearances for tests from DiaSorin, Roche Diagnostics, and Inova Diagnostics, according to the agency's website.

DiaSorin nabbed a clearance for its Liaison Anti-HAV chemiluminescent immunoassay to detect total antibodies to the hepatitis A virus in serum and plasma samples. The laboratory-based test, performed on DiaSorin's Liaison analyzers, detects current or previous hepatitis A infections and the presence of an antibody response to the hepatitis A virus in vaccine recipients.

The FDA also cleared the Saluggia, Italy-based diagnostic company's Liaison Lyme IgG chemiluminescent immunoassay to detect IgG antibodies to Borrelia burgdorferi in serum and plasma samples from patients suspected of Lyme disease. The test must be performed on DiaSorin's Liaison XL analyzer, the FDA said, adding that it can also be used for the confirmation of Lyme disease as part of a modified two-tier test with the DiaSorin Liaison Lyme Total Antibody Plus assay.

The agency further greenlighted the Roche Cobas Influenza A/B & RSV nucleic acid test for use on the firm's Cobas Liat point-of-care system. The automated, multiplex real-time RT-PCR assay rapidly detects and discriminates RNA associated with influenza A, influenza B, and respiratory syncytial virus in nasopharyngeal swabs from patients with symptoms of respiratory infection.

In February, Basel, Switzerland-based Roche announced that its Cobas BKV test, previously cleared for use with ethylenediaminetetraacetic acid (EDTA), received 510(k) clearance for use with stabilized urine samples. And San Diego-based Inova Diagnostics, which is owned by Spanish diagnostics firm Werfen, announced clearance for its Nova Lite DAPI dsDNA Crithidia Luciliae Kit for the qualitative and semi-quantitative determination of anti-double-stranded DNA (dsDNA) IgG antibodies.