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FDA Clears Assays from Bio-Rad, Roche, and Others

NEW YORK (360Dx) – The US Food and Drug Administration cleared assays from Bio-Rad Laboratories for Toxoplasma gondii and for Treponema pallidum in May, the agency disclosed.

The two Bio-Rad assays are among a handful of tests that the agency cleared last month. Others included assays from Roche, Siemens Healthineers, and BRAHMS.

The BioPlex 2200 ToRC IgM kit from Bio-Rad is a multiplex immunoassay intended for use on Bio-Rad's BioPlex 2200 system for the qualitative detection of IgM antibodies to Toxoplasma gondii, rubella, and cytomegalovirus in human serum and plasma. The assay is not cleared as a screening tool for blood or plasma donors, the FDA noted.

The agency also cleared the BioPlex Syphilis Total & RPR kit for use on the BioPlex 2200 system. The kit is a multiplex flow immunoassay for the qualitative detection of whole IgG/IgM antibodies to T. pallidum and the qualitative detection and/or titer determination of non-treponemal reagin antibodies in human serum or plasma.

Also in May, the FDA provided 501(k) clearance for Roche's Creatine Kinase-MB assay, an in vitro test to determine the catalytic activity of creatine kinase MB subunit in human serum and plasma. Creatine phosphokinase and its isoenzymes are used to diagnose and treat myocardial infarction and muscle diseases, including progressive, Duchenne-type muscular dystrophy, the FDA said. Roche's test is intended for use on Roche's Cobas c systems.

The agency also cleared Siemens Healthineers' Advia Centaur Intact Parathyroid Hormone assay. The in vitro diagnostic test is intended for use on the Advia Centaur XP system and is for the quantitative determination of intact parathyroid hormone in serum and plasma. The assay can differentially diagnose hyperparathyroidism, hypoparathyroidism, and calcium metabolic disorders.

BRAHMS' PCT-sensitive Kryptor immunofluorescent assay was cleared by the FDA for determining the concentration of procalcitonin in human serum and ethylenediaminetetraacetic acid, or heparin plasma. The assay is to help assess patients suspected of having sepsis, and is for use on BRAHMS' Kryptor family of analyzers.

The FDA noted that the assay is not intended as a standalone diagnostic, and it should be used in conjunction with clinical signs and symptoms of infection and other diagnostic evidence.