NEW YORK – The US Food and Drug Administration in January granted 510(k) marketing clearances for a C-reactive protein assay, a molecular test for gonorrhea, and blood collection tubes for use in in vitro diagnostics, among other testing products.
Siemens Healthineers got the agency's go-ahead for a C-reactive protein assay that can be used to help determine a patient's risk of cardiovascular disease. The Erlangen, Germany-based firm's Atellica CH High Sensitivity C-Reactive Protein 2 is a particle-enhanced immunonephelometry-based assay that is used for the quantitative determination of C-reactive protein concentrations in serum and plasma samples. It is designed for use on the firm's Atellica CH Analyzer, and it can be used in conjunction with traditional clinical laboratory evaluation to evaluate acute coronary syndromes or as an independent prognostic marker of recurring events in patients with stable coronary disease or acute coronary syndromes.
Marlborough, Massachusetts-based Hologic received the green light for an assay that is used to identify gonorrhea in symptomatic and asymptomatic male patients. The firm's Aptima Neisseria gonorrhoeae Assay is a nucleic acid amplification test (NAAT) that is used for the qualitative detection in urine of ribosomal RNA of Neisseria gonorrhoeae to aid the diagnosis of gonococcal urogenital disease. The assay is designed for use on Hologic's Panther instrument.
Becton Dickinson also secured FDA clearance for its BD Vacutainer Fluoride Blood Collection Tubes that are used for the collection, storage, preservation, transportation, and centrifugation of venous blood samples for in vitro diagnostic testing. The single-use tubes are available with sodium fluoride/potassium oxalate for use in glucose and lactate determination or sodium fluoride/Na2EDTA for glucose determination.
Cranbury, New Jersey-based Nano-Ditech also got a nod for a COVID-19 lateral flow assay. The firm's Nano-Check COVID-19 Antigen Test is designed for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in anterior nasal swab samples that are collected from individuals with signs and symptoms of upper respiratory infection within four days of symptom onset. It is authorized for use in symptomatic individuals who are tested at least twice over three days with at least 48 hours between tests or once with negative results that are confirmed by a molecular test.
Lastly, Chinese diagnostic testing firm Co-Innovation Biotech secured 510(k) clearance for four urine-based tests to detect marijuana consumption. The firm's Rapid Marijuana (THC) Test Strip 20 and Rapid Marijuana (THC) Test Dipcard 20 tests are used for the qualitative detection in urine of marijuana and marijuana metabolites with a cutoff concentration of 20 ng/mL while the firm's Rapid Marijuana (THC) Test Strip 50 and Rapid Marijuana (THC) Test Dipcard 50 have a cutoff concentration of 50 ng/mL.