Life Sciences Insight

Becton Dickinson, Werfen, Viramed Biotech Gain 501(k) Clearances in August

NEW YORK — Becton Dickinson and Viramed Biotech each gained US Food and Drug Administration 510(k) clearance in August for panels to differentiate pathogenic illnesses, and a Werfen subsidiary got the go-ahead for a panel used to evaluate coagulation pathways and Vitamin K antagonist treatment.

Franklin Lakes, New Jersey-based Becton Dickinson got the nod for its BD Max Enteric Parasite Panel, a multiplex assay that uses the BD Max instrument to detect genes of Giardia lambliaEntamoeba histolyticaCryptosporidium hominis, and Cryptosporidium parvum in stool samples of patients with gastrointestinal illness.

Viramed Biotech, based in Germany, secured clearance for its Borrelia All-In-One ViraChip Test Kit, which is used to detect antibodies to Borrelia burgdorferi, the cause of Lyme disease. The qualitative microarray assay identifies IgM and IgG antibodies in blood samples of patients with symptoms of suspected Lyme.

Werfen subsidiary Instrumentation Laboratory also gained clearance for its HemosIL ReadiPlasTin prothrombin time test, an in vitro diagnostic thromboplastin reagent used on Werfen’s ACL TOP analyzers to measure prothrombin time and fibrinogen, which are used evaluate the extrinsic coagulation pathway and monitor oral vitamin K antagonist therapy. Prothrombin time tests are often used to screen for inherited and acquired coagulation disorders and monitor warfarin therapy, according to Werfen.

Also, Poway, California-based Diazyme Laboratories chalked up clearances for its Human Kappa Free Light Chain Assay and Human Lambda Free Light Chain Assay, which are used together to aid in the diagnosis and monitoring of multiple myeloma. The assays are designed for use on the Roche Cobas c501 analyzer.

Three firms also got secured federal clearance for their blood glucose monitoring systems. Taiwan-based Apex Biotechnology can now sell its GlucoSure Link system in the US; fellow Taiwan-based firm HMD Biomedical can sell its GlucoLeader Enhance 2 system; and Hong Kong-based Bioland Technology can sell its G-425-2 and G-425-2V systems.

Also last month, Thermo Fisher Scientific gained 510(k) clearance for its ImmunoCap allergy tests.

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