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Siemens Healthineers, Beckman Coulter, Becton Dickinson, Others Receive FDA Clearances in March

NEW YORK (360Dx) – During March, the US Food and Drug Administration cleared in vitro diagnostic tests from Siemens Healthineers, Beckman Coulter, Becton Dickinson, Abbott, and others, according to the agency's website.

Siemens received clearance for its Dimension Vista High-Sensitivity Troponin I assay for the measurement of cardiac troponin I in plasma using the firm's Dimension Vista system. The assay can be used in the diagnosis of acute myocardial infarction, the FDA said. Last June, the firm obtained FDA clearance for its high-sensitivity troponin I assays for the early diagnosis of myocardial infarction using the company's Atellica IM and Advia Centaur XP/XPT immunoassay analyzers.

Beckman Coulter received three 510(k) clearances, including one for its DxH 520 hematology analyzer, which is designed for low-volume laboratories including those in clinics and physician offices. The firm received CE marking for the analyzer in April last year.

Additionally, the firm received clearance for its ClearLLab 10C Panels for the identification of cell populations by multiparameter immunophenotyping, running on its Navios and Navios EX flow cytometers. The panels consist of reagents used in the differential diagnosis of patients having, or suspected of having, the following hematopoietic neoplasms — chronic leukemia, acute leukemia, non-Hodgkin lymphoma, myeloma, myelodysplastic syndrome, and/or myeloproliferative neoplasms.

To complete the trifecta of clearances, Beckman got the nod for its UniCel DxH 800 Coulter Cellular Analysis System with Early Sepsis Indicator Application. The Early Sepsis Indicator is intended for use with adult patients presenting to the emergency department with sepsis symptoms and for whom a clinician has ordered a white cell differential test.

Becton Dickinson got the nod for its BD Vacutainer Eclipse UltraFill Blood Collection Needle. The single-use medical device is designed with an attached safety shield, which can be activated to cover the needle immediately after puncture, providing protection from accidental needle sticks.

Abbott's Alere business received clearance for the ID Now Influenza A & B 2 assay performed on its ID Now instrument. The rapid molecular diagnostic test uses isothermal nucleic acid amplification for the detection and discrimination of influenza A and B viral RNA in patients with signs and symptoms of respiratory infection.

BioMérieux was granted 510(k) clearance for the Vitek 2 AST-Gram Negative Delafloxacin test designed for antimicrobial susceptibility testing of gram-negative bacilli running on the firm's Vitek 2 and Vitek 2 Compact systems. According to the FDA label for delafloxacin (Baxdela), the antimicrobial has been shown to be active against most strains of Escherichia coli, Enterobacter cloacae, Klebsiella pneumoniae, and Pseudomonas aeruginosa.

The FDA cleared Hangzhou AllTest Biotech's Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), a rapid chromatographic immunoassay for the detection of single or multiple drugs and drug metabolites in urine. The assay provides a preliminary analytical test result, the FDA said.

Thermo Fisher Scientific's Phadia got the go-ahead for its EliA Celikey IgG, EliA GliadinDP IgA, and EliA GliadinDP IgG immunoassays. The EliA Celikey IgG immunoassay is used to measure IgG antibodies directed to tissue transglutaminase in serum and EDTA-plasma, running on the Phadia 2500 and Phadia 5000 platforms. Both the EliA GliadinDP IgA and EliA GliadinDP IgG immunoassays are used to measure antibodies directed to gliadin in human serum or plasma to diagnose celiac disease.

Also, the FDA granted clearance to GenePOC for a rapid molecular assay to detect group A Streptococcus, and to Hitachi Chemical Diagnostics for its Optigen AP 3600 high capacity allergy testing system.

Roche also announced that it had garnered approval for its Ventana PD-L1 (SP142) Assay as a companion diagnostic for identifying which triple-negative breast cancer patients have increased PD-L1 expression on tumor-infiltrating immune cells and are more likely to respond to the immunotherapy Tecentriq (atezolizumab) plus chemotherapy.