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Tests, Systems From Beckman Coulter, BioMérieux, Siemens Healthineers Receive FDA Clearance in December

NEW YORK (360Dx) – Beckman Coulter, BioMérieux, and Siemens Healthineers each received multiple US Food and Drug Administration clearances for its tests last month, according to the FDA's website.

Beckman Coulter, a Danaher company, had four tests cleared by the agency, while BioMérieux and Siemens Healthineers each had two clearances.

The FDA cleared three separate Beckman Coulter MicroScan Dried Gram-Negative MIC/Combo Panels 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."

The assays are MicroScan Dried Gran-Negative MIC /Combo Panels with CeftazidimeAvibactam (.24/4 – 64/4 micrograms/milliliter); MicroScan Dried Gran-Negative MIC /Combo Panels with Ciprofloxacin-S (.004 – 8 micrograms/milliliter); and MicroScan Dried Gran-Negative MIC /Combo Panels with Ceftolozane/Taxobactam (.25/4 – 16/4 micrograms/milliliter).

Beckman Coulter's chemiluminescent immunoassay for determining anti-Müllerian hormone levels also received 510(k) clearance.

BioMérieux similarly had multiple clearances from the FDA for one assay, but with two different drugs. The Vitek 2 AST-GN test was cleared for use with Amikacin (≤1 – ≥ 64 micrograms/milliliter) and with Ceftazidime/Avibactam (≤.12 – ≥16 micrograms/milliliter). The tests are for antimicrobial susceptibility testing of Gram-negative bacilli on the Vitek 2 and Vitek 2 Compact Systems as a laboratory aid in determining in vitro susceptibility to antimicrobial agents, FDA documents said. Both assays are quantitative tests.

Meanwhile, Siemens Healthineers received clearance for the Sysmex Automated Blood Coagulation Analyzer CS-2500, a fully automated blood coagulation analyzer for in vitro diagnostic hemostasis based on plasma collected from venous blood samples in 3.2 percent sodium citrate tubes.

Siemens and Sysmex have a global partnership covering hemostasis testing. The platform is for determining, among other things, factor V Leiden, coagulation factor VIII, and coagulation factor IX.

The FDA also cleared Siemens Healthineers' Advia Chemistry Enzymatic Hemoglobin A1c assay. The IVD test quantitatively determines mmol/mol HbA1c and percent HbA1c in human anticoagulated venous whole blood and hemolysate, and is for use on Advia Chemistry systems.

Also 510(k) cleared last month was the Alere BinaxNOW Influenza A & B Card 2 and Alere Reader. The IVD immunochromatographic assay qualitatively detects influenza A and B nucleoprotein antigens in nasopharyngeal swab and nasal swab specimens. Alere was purchased by Abbott in October for $5.3 billion.

Additionally, an assay from Euroimmun, now part of PerkinElmer, the Anti-Borrelia burgdorferi US Euroline-WB kit, received FDA clearance for qualitatively determining IgM class antibodies against Borrelia burgdorferi in human serum and plasma samples that have been found to be positive or equivocal/borderline using an enzyme immunoassay or immunofluorescence assay test procedure for Borrelia burgdorferi antibodies.

And Fujirebio Diagnostics' Lumipulse G BRAHMS PCT test was cleared for quantitatively determining procalcitonin in human serum and plasma. The test is a chemiluminescent enzyme immunoassay and runs on the Lumipulse G system.

Other companies that received FDA clearance for their tests or testing systems in December include Quidel, whose Group B Strep assay for use with the Solana platform, and Group A Strep test for use with the Sofia 2 system received the nod for marketing in the US.

Ortho Clinical Diagnostics was cleared to market its Vitros Imunodiagnostic Products HIV Combo Reagent Pack and Calibrator.

Precision oncology diagnostic firm MolecularMD also received FDA authorization for its MRDx BCR-ABL test for identifying Philadelphia chromosome-positive chronic CML patient treated with the BCR-ABL tyrosine kinase inhibitor Tasigna who are candidates for discontinuation and monitoring of treatment-free remission.