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BioMérieux, Philips Electronics, Beckman Coulter, Others Get 510(k) Clearances in September

NEW YORK – The US Food and Drug Administration cleared in vitro diagnostic tests and systems in September from BioMérieux, Philips Electronics, Beckman Coulter, Binding Site Group, and others, according to the agency's website.

It cleared Marcy-l'Étoile, France-based BioMérieux to market its ETest Eravacycline assay for determining the antimicrobial susceptibility of non-fastidious Gram-negative and Gram-positive aerobic bacteria and fastidious bacteria. The system consists of a predefined antibiotic gradient used to determine the minimum inhibitory concentration (MIC) of different antimicrobial agents against microorganisms tested on agar media using overnight incubation. According to the FDA, the test can be used to determine the MIC of Tetraphase Pharmaceuticals' eravacycline (Xerava) antibacterial agent against a range of microorganisms.

Netherlands-based Philips Electronics received 510(k) clearance for the Philips IntelliSite Pathology Solution (PIPS) with a modified display. PIPS is an automated digital slide creation, viewing, and management system for pathologists reviewing and interpreting digital images of surgical pathology slides prepared from formalin-fixed, paraffin-embedded tissue. The platform consists of an image management system, ultra-fast scanner, and display. The FDA had previously cleared the Philips IntelliSite Pathology Solution through its de novo regulatory review pathway, making it the first time that the agency has allowed the marketing of a whole-slide imaging system.

Birmingham, UK-based Binding Site Group received clearance for its Human IgA liquid reagent kit for use on it Spaplus turbidimetric analyzer. The kit is used to detect human IgA in serum, lithium heparin, or ethylenediaminetetraacetic acid (EDTA) plasma for the diagnosis of abnormal protein metabolism, and to diagnose the body's inability to resist infectious agents.

The FDA gave Brea, California-based Beckman Coulter the nod for its FC 500 MPL and MCL flow cytometers, which measure biological and physical properties of cells and other particles as they pass through laser beams in a single file.

Shandong, China-based Qingdao Hightop Biotech received clearance for its Pregnancy Rapid Test to measure human chorionic gonadotropin (hCG) in detecting pregnancy early. The test uses a colloidal gold immunochromatography assay to detect hCG in urine at a cut-off of 25 mIU/ml.

The FDA gave the go-ahead to Shenzhen Bioeasy Biotechnology for its Bioeasy Marijuana Test Dip Card and Bioeasy Marijuana Test Strip — lateral flow immunochromatographic assays for providing preliminary results in detecting marijuana in urine at a cutoff concentration of 50 ng/mL.

In September, the FDA granted clearance to Luminex for its the real-time PCR-based Aries MRSA Assay running on its Aries sample-to-answer system; to Exact Sciences for an expanded indication for its Cologuard colorectal cancer test to average-risk individuals aged 45 and older; and to Cepheid for its Xpert BCR-ABL Ultra test for monitoring disease burden in patients with chronic myeloid leukemia.

The agency also cleared Bühlmann Laboratories for use of its Calex Cap fecal extraction device with its fecal calprotectin test; for its smartphone-based albumin-to-creatinine ratio test to diagnose chronic kidney disease; and Abbott for its high-sensitivity troponin-I blood test to detect heart attacks.

Additionally, Roche received marketing approval for its Cobas Babesia blood test for individual blood donation testing.