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Siemens Healthineers, EKF Diagnostics, Immucor, Horiba, Others Get FDA Clearances in June

NEW YORK ─ The US Food and Drug Administration, which continued to review and grant Emergency Use Authorizations for SARS-CoV-2 testing in June, also granted 510(k) clearances for tests from a handful of in vitro diagnostic companies, including Siemens Healthineers, EKF Diagnostics, Immucor, Horiba, and others, according to the agency's website.

Among the recipients of 510(k) clearances, Siemens Healthineers' Epocal business got the green light for its Epoc Blood Analysis System, which is used by trained medical professionals to test for a broad range of conditions in the lab or at the point of care. The Epoc Blood Analysis System's Blood Gas Electrolyte and Metabolite Test Card, for example, includes sensors that measure pH, sodium, potassium, ionized calcium, chloride, total carbon dioxide, glucose, lactate, blood urea nitrogen, creatinine, and hematocrit. Ionized calcium measurements alone are used to diagnose and treat parathyroid disease, a variety of bone diseases, chronic renal disease, and tetany.

Cardiff, UK-based EKF Diagnostics received clearance for its Hemo Control analyzer and associated hemoglobin microcuvette, accessories, and consumables. The Hemo Control analyzer ─ a semi-automated spectrophotometric instrument ─ provides instant total hemoglobin results. In the system, arterial, venous, or capillary blood is drawn by capillary action into a microcuvette that has a reagent. The microcuvette is inserted into the Hemo Control analyzer, and the color produced by a chemical reaction enables the hemoglobin value to be calculated and displayed.

The FDA gave Waukesha, Wisconsin-based Immucor GTI Diagnostics the go-ahead for its PF4 IgG ELISA assay to detect IgG antibodies that react with platelet factor 4 when it is complexed to heparin or other polyanionic compounds. Heparin-associated antibodies are common in patients with heparin-induced thrombocytopenia.  

Kyoto, Japan-based Horiba received FDA clearance for its Yumizen C1200 CRP reagent used to measure C-reactive protein for evaluation of infections, tissue injury, and inflammatory disorders.

Santa Clara, California-based Lin-Zhi International nabbed a clearance for its LZI Tramadol Enzyme Immunoassay for the measurement of tramadol in human urine. The assay is designed for prescription use with a number of automated clinical chemistry analyzers, the FDA said.

And in other US regulatory news during June, Chembio Diagnostics announced that it had received clearance for its DPP Zika IgM System, which includes the DPP Zika IgM Assay and DPP Micro Reader.