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FDA Issues Clearances in March to Siemens Healthineers, Beckman Coulter, Abbott, BioMérieux, Others

NEW YORK ─ The US Food and Drug Administration granted 510(k) clearances in March for tests from Siemens Healthineers, Beckman Coulter, Abbott, BioMérieux, Inspirata, and others, according to the agency's website.

Siemens Healthineers obtained clearance for its N Latex FLC kappa and lambda assays for the quantitative detection of kappa and lambda-free light chains in serum and plasma. The assays are used to diagnose and monitor multiple myeloma on Siemens' BN Systems and Atellica CH Analyzer, and to diagnose and monitor immunoglobulin light-chain amyloidosis on the BN Systems and Atellica CH Analyzer.

The assays are also used to evaluate monoclonal gammopathy of undetermined significance on the BN Systems and Atellica CH Analyzer.

Beckman Coulter nabbed a clearance for its Total Immunoglobulin E (IgE) reagent kit, a quantitative immunoturbidimetric assay for the quantitative detection of total IgE concentration in human serum and plasma. The test, which runs on Beckman Coulter's AU480, AU680, AU5800, and DxC 700 AU clinical chemistry analyzers, is used to diagnose IgE-mediated allergic disorders.

Abbott Laboratories obtained clearance for its GLP Systems Track, which is used with clinical laboratory analyzers such as the firm's Alinity c System to automate preanalytical and post-analytical sample processing including sample handling. The system consolidates multiple analytical instruments into a unified workflow.

The Abbott Ireland Diagnostics division of Abbott Laboratories obtained clearance for the Creatinine2 colorimetric assay to detect creatinine in human serum, plasma, or urine on the Architect c8000 system. The assay is used in the diagnosis of renal diseases, monitoring of renal dialysis, and measurement of other urine analytes.

Abbott Ireland Diagnostics also obtained clearance for its Albumin BCP2 assay to detect albumin in human serum or plasma on the Architect c8000 system and to diagnose numerous diseases involving primarily the liver or kidneys.

The FDA granted clearance to Healgen Scientific for its Strep A Rapid Test Strip, a rapid chromatographic immunoassay for the detection of the Streptococcus pyogenes antigen. The assay uses throat swab specimens taken from patients with symptoms of group A Streptococcus bacterial infection.

SPD Swiss Precision Diagnostics obtained clearance for its One Step Pregnancy Test, an over-the-counter lateral flow immunoassay for the qualitative detection of human chorionic gonadotropin in urine. The visual test can be used at home for the early detection of pregnancy.

Also, Athelas obtained clearance for its Athelas Home system used with Athelas Home test strips for the quantitative detection of white blood cells and neutrophil percentages in capillary whole blood. The Athelas Home system is used at home by patients at risk of neutropenia and provides results that are viewable by healthcare professionals.

Meanwhile, BioMérieux announced FDA clearance for its Vitek MS Prime MALDI-TOF mass spectrometry identification system, and Immucor said it had obtained clearance for its Luminex single antigen product Lifecodes LSA Class I and Class II Assays in conjunction with its Match It! Antibody Software. Inspirata announced it received clearance for its Dynamyx digital pathology software, allowing customers to use whole-slide images rather than traditional glass slides for primary diagnosis of cancers and other conditions.