NEW YORK – The US Food and Drug Administration in July granted 510(k) marketing clearance to a pair of hematology analyzers, various immunoassays for chronic and emergency uses, and respiratory disease tests, among other tests and instruments.
Danaher subsidiary Beckman Coulter got clearances from the agency for two automated hematology analyzers and a slide preparation and staining instrument as well as updated clearances for two immunoassays. The Brea, California-based firm's UniCel DxH 900 Coulter Cellular Analysis System and UniCel DxH 690T Coulter Cellular Analysis System are quantitative multiparameter automated hematology analyzers that are used with whole blood, pre-diluted whole blood, and bodily fluid samples. The DxH 900 instrument can be used as part of a modular multi-analyzer while the DxH 690T is a standalone tabletop instrument.
Meanwhile, Beckman Coulter's UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System is a fully automated slide preparation and staining device that is used to aspirate a whole blood sample, smear a blood film onto a microscope slide, and apply fixatives, stains, buffers, and rinse solutions.
Beckman Coulter also received updated clearances for two immunoassays to allow the use of a different substrate and perform the tests on the firm's DxI 9000 Access Immunoassay Analyzer. The firm's Access Thyroglobulin Antibody II is used for the quantitative determination of thyroglobulin antibody levels in serum and plasma to aid the diagnosis of Hashimoto's disease, nontoxic goiter, and Graves' disease, whereas the Access sTfR is used for the quantitative determination of soluble transferrin receptor levels in serum and plasma to aid the diagnosis of iron deficiency anemia (IDA) and the differential diagnosis of IDA and anemia that is connected with chronic disease. The Access sTfR test also may be performed in conjunction with an Access Ferritin test to provide a sTfR/log ferritin index.
Siemens Healthineers got the green light for a pair of assays that are used to measure a patient's HDL and LDL cholesterol levels. The Atellica CH HDL Cholesterol (HDLC) assay is used for the quantitative determination of HDL cholesterol and the Atellica CH LDL Cholesterol (LDLC) assay is used for the quantitative determination of LDL cholesterol. Both assays are used with serum and plasma samples and are designed for use on the Atellica CI Analyzer.
Siemens also secured FDA clearance for an update to an immunoassay for the measurement of high-sensitivity cardiac troponin I. The Erlangen, Germany-based firm's Atellica IM High Sensitivity Troponin I (TnIH) assay was previously cleared for the quantitative measurement of cardiac troponin I in serum or plasma for the diagnosis of acute myocardial infarction, and the assay now can also be used to aid the prognosis of major adverse cardiac events and death over 30-, 90-, 182-, and 365-day periods in patients with signs and symptoms of acute coronary syndrome.
Marlborough, Massachusetts-based Hologic secured updated clearance for a molecular respiratory panel to reduce the risk of false positive results for flu B and allow the use of another sample type with the test. The firm has modified the software that is used for the interpretation of its Panther Fusion SARS-CoV-2/Flu A/B/RSV assay results to eliminate the risk of false positives for flu B in samples that are positive for SARS-CoV-2 as well as secured clearance for the use of the test with anterior nasal swab samples. The firm previously receive clearance for use of the test with nasopharyngeal swab samples.
Thermo Fisher Scientific subsidiary Life Technologies gained marketing clearance for a molecular test for COVID-19. The TaqPath COVID-19 Diagnostic PCR Kit is used for the qualitative detection of SARS-CoV-2 RNA in nasopharyngeal and anterior nasal swab samples from individuals who have signs and symptoms of respiratory tract infection. The test is designed for use with Applied Biosystems' 7500 Fast Dx Real-Time PCR and Quantstudio 5 Dx Real Time PCR instruments.
Cranbury, New Jersey-based Nano-Ditech got a nod for a lateral flow immunoassay for respiratory syncytial virus infections in children and older adults. The firm's Nano-Check RSV Test is used for the qualitative detection of RSV nucleoprotein antigen in anterior nasal swab samples from patients who have signs and symptoms of respiratory infection. The test is designed for use in children ages 6 months to 6 years old and adults older than 60 years.
Bedford, Massachusetts-based Medica secured the FDA's go-ahead for the use of its EasyStat 300 benchtop analyzer to aid the diagnosis and treatment of metabolite disturbances including diabetes mellitus, idiopathic hypoglycemia, pancreatic inlet cell carcinoma, anemia, and erythrocytosis. The clearance allows the use of the cartridge-based instrument for the quantitative determination of glucose and hematocrit concentrations in whole-blood samples. The company received clearances in January 2023 for the use of the instrument for quantitative measurements partial pressure of oxygen, partial pressure of carbon dioxide, and hydrogen ion activity to aid the diagnosis and treatment of blood gas and/or acid-base disturbances. In September 2023 the instrument was cleared for the quantitative determination of potassium, ionized calcium, and chloride in whole-blood samples to aid the diagnosis and treatment of electrolyte or acid-base disturbances.
Lastly, Santa Maria, California-based Hardy Diagnostics secured 510(k) clearance for an antimicrobial susceptibility test disk and a predetermined change control plan to address revisions to the device labeling in response to FDA-recognized breakpoint changes. The firm's HardyDisk AST Cefiderocol 30µg (FDC30) is used for semi-quantitative testing through the agar diffusion test procedure of the susceptibility of bacterial pathogens to the antibiotic cefiderocol.