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Becton Dickinson, DiaSorin, Roche Obtain FDA 510(k) Clearances in September

NEW YORK — The US Food and Drug Administration granted 510(k) clearances in September for tests from Becton Dickinson, DiaSorin, Roche, and others, according to the agency's website.

Becton Dickinson got the green light from the agency for an updated version of its BD Max Enteric Viral Panel that uses stool specimens collected using the Copan FecalSwab and BD FecalSwab systems in a real-time PCR assay on the BD Max instrument. The assay detects norovirus GI and GII, rotavirus A, adenovirus F40/41, sapovirus genogroups 1-5, and human astrovirus.

Saluggia, Italy-based DiaSorin previously announced it had gained 510(k) clearance for its Simplexa COVID-19 Direct test. The automated molecular assay identifies the SARS-CoV-2 virus in nasopharyngeal or nasal swabs, and it is designed for use by hospitals and commercial laboratories on DiaSorin's real-time PCR-based Liaison MDx instrument.

Roche Diagnostics also gained 510(k) clearance for a modification that reduces biotin interference in its Elecsys AFP immunoassay, which is used for quantitative identification of alpha-fetoprotein in serum and plasma and to aid management of patients with non-seminomatous germ cell tumors. That assay is used on the firm's Cobas E 601 immunoassay analyzer.

Roche was also cleared to add previously cleared glucose, sodium, thyroid stimulating hormone, and methadone assays to the Cobas Pure Integrated Solutions automated analyzer. The instrument runs qualitative, semi-quantitative, and quantitative clinical chemistry and immunochemistry assays as well as ion selective measurements.

Meanwhile, the agency gave the nod to Agendia for its MammaPrint FFPE NGS assay kit for breast cancer prognosis. The 70-gene in vitro tumor profiling test uses next-generation sequencing to identify a gene expression signature that can help identify a patient's risk of developing metastasis within five years and up to 10 years after diagnosis. It is designed for use on the Illumina MiSeqDx.

Durham, North Carolina-based Baebies nabbed clearance for its Finder G6PD test, which measures glucose-6-phosphate dehydrogenase in blood samples. The assay aids in the identification of G6PD deficiency, and it can be used on the company's Finder instrument.

Poway, California-based Diazyme Laboratories also secured approval for an update to revise the limits of quantification claim for its Diazyme Human Kappa Free Light Chain Assay and Human Lambda Free Light Chain Assay, which are used to monitor multiple myeloma. And SPD Swiss Precision Diagnostics also nabbed clearance for its over-the-counter Clearblue Early Pregnancy Test, a chromatographic immunoassay for qualitative detection of human chorionic gonadotropin in urine.