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Abbott, Beckman Coulter, Thermo Fisher Scientific, Others Gain FDA Clearances in August

NEW YORK – The US Food and Drug Administration in August granted new 510(k) clearances for hematology analysis instruments from Abbott and PixCell Medical Technologies as well as assays to detect infectious diseases, reagents used to aid patient management, and antimicrobial susceptibility tests.

Abbott nabbed 510(k) clearance for its Alinity H-Series System that can incorporate one or multiple integrated hematology analyzers and an optional slide maker stainer. The Alinity HQ analyzer provides complete blood counts and a six-part white blood cell differential for normal and abnormal cells in capillary and venous whole blood. The Alinity HS slide maker stainer module is used to automate whole-blood film preparation and staining and to stain externally prepared whole-blood smears.

The Abbott Park, Illinois-based firm also secured separate clearances for tests for hepatitis A and COVID-19. Its HAVAb IgG II assay is a chemiluminescent microparticle immunoassay for qualitative detection of IgG antibodies to the hepatitis A virus in serum and plasma of adults or children with signs, symptoms, or risk of hepatitis A. The test is designed for use on the Alinity I system. The firm also secured clearance for its ID Now COVID-19 2.0 rapid isothermal nucleic acid amplification technology (NAAT) test for the qualitative detection of SARS-CoV-2 in anterior nasal or nasopharyngeal swab samples from patients with signs and symptoms of respiratory tract infection. That test is designed for use on Abbott's ID Now instrument to aid the diagnosis of COVID-19 in conjunction with other clinical, epidemiologic, and laboratory findings.

Sunnyvale, California-based Cepheid got the FDA's go-ahead for a syndromic molecular test for respiratory infections using nasopharyngeal or anterior nasal swab samples. The firm's Xpert Xpress CoV-2/Flu/RSV Plus is an automated multiplex real-time RT-PCR test for qualitative detection and differentiation of SARS-CoV-2, influenza A/B, and respiratory syncytial virus infections.

Beckman Coulter got the green light for a system reagent used to measure IgG to aid in the diagnosis of abnormal protein metabolism and an inability to resist infectious agents. The Brea, California-based firm's Immunoglobulins A, G, M, D, and E Immunological Test System is used for the quantitative measurement of IgG in serum, plasma, and cerebrospinal fluid, and it is designed for use on Beckman Coulter's AU/DxC AU analyzers.

Waltham, Massachusetts-based Thermo Fisher Scientific secured three 510(k) clearances for clinical susceptibility tests in its Sensititre line. The Sensititre YeastOne Susceptibility System with rezafungin in the dilution range of 0.008-8 µg/ml is used to test for susceptibility of Candida spp., while the Sensititre 20-24-Hour Haemophilus Influenzae/Streptococcus Pneumoniae MIC or Breakpoint Susceptibility System with dalbavancin in the dilution range of 0.0005-2 µg/ml is used to test for susceptibility of fastidious isolates, and the Sensititre 18-24-Hour MIC or Breakpoint Susceptibility System with sulbactam-durlobactam in the dilution range of 0.015/4-32/4 µg/ml is used to test for susceptibility of non-fastidious isolates.

Zeus Scientific gained FDA clearance for an assay to aid diagnosis of lupus erythematosus. The Branchburg, New Jersey-based firm's Zeus IFA nDNA Test System is an indirect immunofluorescence assay for qualitative and semi-quantitative determination of anti-native DNA IgG antibodies to DNA in serum by manual fluorescence microscopy or the Zeus dIFine digital immunofluorescence system.

PixCell Medical Technologies also got the agency's go-ahead for direct capillary sampling using the firm's HemoScreen complete blood count analyzer. The clearance is an update to the Israeli firm's HemoScreen point-of-care automated hematology analyzer, which had been cleared in 2018 for use with venous and capillary blood samples. The firm has said its direct capillary sampling method is faster, less painful, and less prone to pre-analytical errors than collection methods used in competing devices.

Lastly, Ortho Clinical Diagnostics, now QuidelOrtho, secured a pair of FDA marketing clearances for its cancer diagnostics products. The Raritan, New Jersey-based firm's Vitros Immunodiagnostic Products CA 19-9TM Reagent Pack is used for quantitative measurement of 1116-NS-19-9 defined antigen in serum and plasma to monitor disease status and aid management of patients diagnosed with cancers of the exocrine pancreas. The Vitros Immunodiagnostic Products CEA Reagent Pack is used for the quantitative measurement of carcinoembryonic antigen concentration in serum and plasma to aid the prognosis and management of cancer patients who have observed changes in their CEA concentrations. Both reagent packs are designed for use on the firm's Vitros 5600 Integrated System.

For 360Dx's FDA 510(k) tracker, click here.