According to a report from 360 DX, the US Food and Drug Administration (FDA) recently announced that it has cleared tests and systems from reliable manufacturers such as Beckman Coulter, BioMérieux, and Siemens Healthineers. While the FDA cleared four tests for Beckman, BioMérieux and Siemens Healthineers each received two clearances.
For Beckman Coulter, the agency cleared three separate MicroScan Dried Gram-Negative MIC/Combo Panels and chemiluminescent immunoassay for determining anti-Müllerian hormone levels. The Combo Panels are used for the quantitative and/or qualitative evaluation of "antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-negative bacilli."
BioMérieux similarly received multiple clearances from the FDA for one assay, Vitek 2 AST-GN test, but with two different drugs - Amikacin (≤1 - ≥ 64 micrograms/milliliter) and Ceftazidime/Avibactam (≤.12 - ≥16 micrograms/milliliter).
Siemens Healthineers that has a global partnership with Sysmex covering hemostasis testing received 510(k) clearance for the Sysmex Automated Blood Coagulation Analyzer CS-2500. This fully automated blood coagulation analyzer is intended for in vitro diagnostic hemostasis based on plasma collected from venous blood samples in 3.2 percent sodium citrate tubes.
FDA also cleared Siemens' Advia Chemistry Enzymatic Hemoglobin A1c assay that quantitatively determines mmol/mol HbA1c and percent HbA1c in human anticoagulated venous whole blood and hemolysate, and is for use on Advia Chemistry systems.
Other manufacturers who received 510(k) clearance include Alere purchased by Abbott for Alere BinaxNOW Influenza A & B Card 2 and Alere Reader, Euroimmun now part of PerkinElmer for Anti-Borrelia burgdorferi US Euroline-WB kit, Fujirebio Diagnostics' Lumipulse G BRAHMS PCT test, Quidel's Group B Strep assay and Group A Strep test, Ortho Clinical Diagnostics' HIV Combo Reagent Pack and Calibrator, and MolecularMD's MRDx BCR-ABL test.