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Meridian Bioscience, Beckman Coulter, Selux Diagnostics, Arkray Nab FDA Clearances in April

NEW YORK – The US Food and Drug Administration in April granted 510(k) clearances for tests by Meridian Bioscience, Beckman Coulter, Selux Diagnostics, and Arkray, among others.

Meridian Bioscience, now owned by SD Biosensor, got a nod for its Curian Shiga Toxin qualitative fluorescent immunoassay for detection and differentiation of Shiga toxins 1 and 2 in stool samples. The Cincinnati-based firm's assay is designed for use on its Curian analyzer and is intended to aid in the diagnosis of infections caused by Shiga toxin-producing Escherichia coli, including non-O157 strains.

Beckman Coulter also secured a go-ahead for updates to its Access PCT assay to measure procalcitonin and help assess the risk of sepsis or septic shock among critically ill patients within their first day of ICU admission. Brea, California-based Beckman Coulter, which is part of Danaher, received 510(k) clearance for a previous version of the test in January 2020.

Selux Diagnostics previously announced that it gained FDA 510(k) clearance in April for its Gram-negative antimicrobial susceptibility panel on the firm's Next Generation Phenotyping System for rapid AST. The Boston-based company's AST panel adds 23 Gram-negative antimicrobial targets to its antimicrobial susceptibility testing platform.

Kyoto, Japan-based Arkray nabbed clearance for its fully automated Aution Max AX-4060 Urinalysis System. The urine chemistry analyzer uses Aution Sticks 9EB Test Strips with urine samples to provide qualitative and semi-quantitative measurements of glucose, protein, bilirubin, urobilinogen, pH levels, blood, ketones, nitrite, leukocytes, turbidity, and color to evaluate kidney, urinary, liver, or other metabolic disorders.

Salem, New Hampshire-based American Laboratory Products Company also gained FDA 510(k) clearance for a quantitative immunoassay for fecal calprotectin in a stool sample. The ALPCO Calprotectin Immunoturbidimetric Assay is intended to aid in the diagnosis of inflammatory bowel disease, specifically Crohn's disease and ulcerative colitis, as well as to differentiate inflammatory bowel disease from irritable bowel syndrome.

Kurin also got the go-ahead for its blood culture collection instruments intended to reduce contamination compared to blood cultures collected through standard practices. The San Diego-based firm's Kurin Lock instruments divert a small amount of an initial blood sample to reduce the risk of contamination and false-positive test results.

California-based Mawi DNA also secured clearance in April for its SARS-CoV-2 sample collection kit. Its iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL) is designed for collection, transportation, and storage of upper respiratory tract and saliva samples, and it is used to inactivate samples suspected of containing SARS-CoV-2 virus. The firm previously said the kit removes the need for RNA extraction during molecular testing.