US FDA 510(K) Clearances for IDS-ISYS and Automated Vitamin D Kit

IDS assay image

Immunodiagnostic Systems Holdings plc (“IDS”), a leading producer of diagnostic testing kits for the clinical and research markets, announces the receipt of 510(k) clearances* from the United States Food and Drug Administration (US FDA) for both the IDS-iSYS immunoassay analyser and the automated IDS-iSYS 25-Hydroxy Vitamin D immunoassay kit.

The receipt of 510(k) clearances enables IDS to market the IDS-iSYS, a fully-automated ‘closed system’ analyser and its flagship product, 25-Hydroxy Vitamin D, in US laboratories undertaking analyses for human diagnostic purposes. It also clears the way to market automated assays for human growth hormone (hGH) and insulin-like growth factor I (IGF-I) since these are not required to be subjected to the pre-market 510(k) process.

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