NEW YORK – The US Food and Drug Administration in August granted 510(k) marketing clearance for immunoassays for various infectious diseases, including Toxoplasma gondii infection, syphilis, mononucleosis, Lyme disease, and COVID-19.
Abbott got the agency's go-ahead for an immunoassay that is used to aid the diagnosis of acute or recent Toxoplasma gondii infection. The Abbott Park, Illinois-based firm's Alinity I Toxo IgM is used for the detection of IgM antibodies to T. gondii in serum, serum separator, and plasma tubes, and it is recommended that the assay be performed in conjunction with a T. gondii IgG assay. It is designed for use on the firm's Alinity I instrument.
San Diego-based QuidelOrtho gained marketing clearance for a syphilis immunoassay. The firm's Vitros Immunodiagnostic Products Syphilis Reagent Pack (Vitros Syphilis test) is used for the qualitative determination of total IgG and IgM antibodies to Treponema pallidum-specific antigens in serum and plasma. The test is used with non-treponemal laboratory tests and clinical findings to aid the diagnosis of syphilis. It is used on QuidelOrtho's automated Vitros 5600 Integrated System.
Werfen subsidiary Biokit received the go-ahead for two fully automated immunoassays that are used to aid the diagnosis of Epstein-Barr virus infection including infectious mononucleosis. The Advia Centaur EBV-EBNA IgG is used for the qualitative detection of IgG antibodies to Epstein-Barr virus nuclear antigen in serum and plasma of pediatric and adult patients, and the Advia Centaur EBV-VCA IgM is used for the qualitative detection of IgM antibodies to the Epstein-Barr virus capsid antigen in serum and plasma in pediatric and adult patients. Each test is intended for use in conjunction with other Epstein-Barr virus biomarkers, and both are designed for use with the Advia Centaur XP instrument.
ID-FISH Technology got the green light for an assay that is used to aid the diagnosis of Lyme disease. The California-based firm's iDart Lyme IgG Immunoblot Kit is an immunoblot assay that is used for the qualitative detection of IgG antibodies to Borrelia burgdorferi in serum of patients who have signs, symptoms, and clinical history that are consistent with Lyme disease. The test is used as part of a modified two-tier testing method for the diagnosis of Lyme disease. Positive test results provide supporting evidence for the presence of antibodies and exposure to B. burgdorferi, while negative results do not preclude infection.
Seattle-based InBios International got FDA clearance for a prescription-use lateral flow assay for COVID-19. The firm's SCoV-2 Ag Detect Rapid Test is for the qualitative detection of the SARS-CoV-2 nucleocapsid protein antigen in anterior nasal swab samples. The test is intended for use in individuals with signs and symptoms of upper respiratory tract infection when they are tested at least twice in three days with at least 48 hours between tests or tested once when a negative result is followed by a confirmatory molecular test.
Bedford, Massachusetts-based Instrumentation Laboratory gained an updated clearance from the agency to allow remote control functions for desktop sharing and remote software delivery on the firm's ACL Top Family 50 Series fully automated coagulation analyzers. The changes apply to the firm's ACL Top 350 CTS, ACL Top 550 CTS, ACL Top 750, ACL Top 750 CTS, and ACL Top 750 LAS instruments that are used for coagulation and fibrinolysis testing in the assessment of thrombosis and hemostasis.
Beckman Coulter secured an updated clearance for an immunoassay that is used to aid the diagnosis of thyroid autoimmune disorders. The Brea, California-based Danaher subsidiary's Access TPO Antibody assay is used for the quantitative determination of thyroperoxidase antibody levels in serum and plasma, and it is designed for use on the firm's Access Immunoassay instruments. The modification allows the performance of the assay with the Lumi-Phos Pro substrate as a replacement for the Lumi-Phos 530 substrate on the DxI 9000 Access Immunoassay Analyzer.
Lastly, the FDA granted clearances to two firms for tests that are used to detect the consumption of drugs of abuse. Qingdao Hightop's Hightop Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel and Hightop Fentanyl/Norfentanyl Urine Rapid Test Panel lateral flow immunochromatographic assays are used to aid the detection of fentanyl and the fentanyl metabolite norfentanyl. Meanwhile, Aicheck Biotech's Pocguide Multi-Drug Test Cup OTC and Pocguide Multi-Drug Test Cup are lateral flow immunochromatographic assays that are used for the simultaneous qualitative detection in urine of 14 substances. The tests from both firms provide preliminary results and more specific chemical methods must be used to obtain confirmed positive results.
For 360Dx's FDA 510(k) tracker, click here.