NEW YORK – The US Food and Drug Administration in July granted 510(k) clearances for clinical chemistry tests, infectious disease assays, and testing instruments by Abbott Laboratories, Beckman Coulter, Siemens Healthineers, and Roche, among others.
Abbott got the agency's go-ahead for an automated test for alkaline phosphatase and a pair of point-of-care tests for prothrombin time and glucose quantification. The firm's Alkaline Phosphatase2 clinical chemistry assay is used for quantitation of alkaline phosphatase in serum or plasma on Architect C System immunoassay analyzers. The results are used to aid the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.
The Abbott Park, Illinois-based firm's I-Stat PTplus Cartridge prothrombin time test is used to quantify the clot time of the extrinsic coagulation pathway when activated by thromboplastin in non-anticoagulated whole blood. The test is used to monitor patients receiving anticoagulant therapy with coumarin derivatives, with results reported in seconds and an international normalized ratio. It is designed for use with Abbott's handheld I-Stat 1 analyzer.
Abbott also secured a separate 510(k) clearance in July for a point-of-care glucose test system for the I-Stat 1 System. The I-Stat CG8+ cartridge is used for quantification of glucose in whole blood to aid the diagnosis, monitoring, and treatment of carbohydrate metabolism disorders such as diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma.
Danaher subsidiary Beckman Coulter secured 510(k) clearance for an automated photometric chemistry analyzer designed for use in small- to medium-volume laboratories along with tests and reagents used for quantitative measurements of glucose, C-reactive protein, sodium, potassium, and chloride. The DxC 500 AU Clinical Chemistry Analyzer is used to measure analytes in fluid samples including serum, plasma, and urine. Beckman Coulter said the analyzer uses the same standardized assays and reagents as the firm's other AU clinical chemistry analyzers.
Erlangen, Germany-based Siemens Healthineers also nabbed an FDA clearance for an update to its homogenous enzyme immunoassay used for qualitative and semi-quantitative determination of buprenorphine in urine. The Emit II Plus Buprenorphine Assay, which was designed for use in various chemistry analyzers, is now also cleared for use on Beckman Coulter's DxC 500 AU analyzer. The assay results should be considered preliminary until confirmation through other methods, preferably gas chromatography/mass spectrometry or liquid chromatography/mass spectrometry, the FDA said.
Siemens also gained FDA clearance in July for its Atellica CI Analyzer for immunoassay and clinical chemistry testing. The firm said the instrument uses the same reagents, consumables, and software as the firm's Atellica Solution instrument but is designed for use in low- to medium-volume laboratories, with throughput of up to 1,120 tests per hour. The system is designed for qualitative and quantitative analysis of fluid samples using photometric, turbidimetric, chemiluminescent, and integrated ion-selective electrode technologies. The FDA also cleared the instrument for use with Siemen's Atellica IM Thyroid Stimulating Hormone 3-Ultra assay to aid diagnosis of thyroid or pituitary disorders, and the Atellica CH Albumin BCP assay used to aid diagnosis and treatment of various diseases, primarily those involving the liver or kidneys.
The agency also granted Siemens a separate 510(k) clearance in July for Siemens' A-Lyte Integrated Multisensor sodium test system for the quantitative determination of sodium, potassium, and chloride in serum, plasma, or urine. The system detects the electrolytes using electrodes that are incorporated into a multisensor, and the system is designed for use on the Atellica CI Analyzer. The results are used in the diagnosis and treatment of conditions including aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic hormone secretion, cystic fibrosis, diabetic acidosis, and diseases characterized by high or low blood potassium levels.
Switzerland-based Roche got a nod for a point-of-care real-time RT-PCR test for COVID-19 and influenza. The Cobas SARS-CoV-2 & Influenza A/B is used with nasopharyngeal swab and anterior nasal swab specimens to provide differential diagnosis of SARS-CoV-2 and influenza A/B infections in patients with suspected respiratory tract infections. The multiplex test is designed for use on the Cobas Liat System.
Franklin Lakes, New Jersey-based Becton Dickinson also got 510(k) clearance for a multiplex molecular test for COVID-19, influenza A/B, and respiratory syncytial virus as well as a test for COVID-19 alone. The firm's multiplex BD Respiratory Viral Panel and its BD Respiratory Viral Panel-SCV2 are real-time RT-PCR assays used with nasopharyngeal swab and anterior nasal swab samples for qualitative detection of viral infections in patients with suspected respiratory tract infections. Both tests are designed for use on the company's BD Max molecular diagnostic system.
Lastly, Numares Health got the go-ahead for a test that measures lipoproteins to identify patients at risk of cardiovascular disease. The firm, which has offices in Boston and Regensburg, Germany, secured clearance for its Axinon LDL-p test system for measuring low-density lipoprotein particles in blood using algorithm-supported biomarker quantification and nuclear magnetic resonance spectroscopy. Numares has said the clearance will help the firm secure clearances for more tests for metabolic conditions.
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