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Immunodiagnostic Systems, Retractable Technologies, Immunalysis Receive FDA 510(k) Clearances in April

NEW YORK ─ The US Food and Drug Administration in April granted 510(k) clearances for tests from Immunodiagnostic Systems, Retractable Technologies, and Immunalysis, according to the agency's website.

The agency granted clearance to Immunodiagnostic Systems for its IDS Cortisol assay to detect cortisol in human serum and plasma on its IDS system. The results of the IDS Cortisol assay are used in conjunction with other clinical and laboratory data to assist clinicians in the diagnosis and treatment of disorders of the adrenal gland.

Retractable Technologies nabbed clearance for its EasyPoint Blood Collection Plus, a blood collection tube holder with an attached needle that facilitates blood collection from patients. The device is used with evacuated blood collection tubes for venous blood collection, and helps to prevent needle stick injuries and contaminated needle exposure.

Immunalysis received 510(k) clearance for its Sefria PCP Oral Fluid Enzyme Immunoassay with a cutoff of 10 ng/mL in oral fluid collected using its Quantisal or Quantisal II Oral Fluid Collection Device. The assay is intended for the qualitative and semi-quantitative analysis of phenylcyclohexyl piperidine, or PCP, in human oral fluid with clinical analyzers. A more specific alternate chemical method must be used to obtain a confirmed analytical result, according to the FDA. Gas chromatography/mass spectrometry or liquid chromatography/tandem mass spectrometry is the preferred confirmatory method.