NEW YORK – The US Food and Drug Administration in January granted 510(k) marketing clearances to tests from Abbott, Roche and Inflammatix, among other companies.
The agency cleared three tests from Abbott Park, Illinois-based Abbott including a multiplex molecular test for sexually transmitted infections.
Abbott's Simpli-Collect STI Test is a qualitative test that is used to identify Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium in patient-collected urine or vaginal swab samples that are shipped from a patient's home or a healthcare facility to a clinical laboratory for testing. The Simpli-Collect STI Test is comprised of the Simpli-Collect Urine Collection Kit, Simpli-Collect Swab Collection Kit, and Abbott's Alinity M STI Assay, which is a real-time RT-PCR assay for the detection of RNA targets. It is designed for use with Abbott's Alinity M System.
The company also received the agency's go-ahead for a point-of-care test that is used to aid the diagnosis of myocardial infarction. The I-Stat hs-TnI Cartridge with the I-Stat 1 System is used for the quantification of cardiac troponin I in whole blood or plasma, and it is designed for use on the I-Stat 1 analyzer.
Abbott's Axis-Shield Diagnostics business also gained clearance for an immunoassay that is used in emergency departments to aid the diagnosis of heart failure. The Alere NT-ProBNP assay for the Alinity I immunoassay system is used for the quantitative determination in serum and plasma of N-terminal pro B-type natriuretic peptide.
Meanwhile, Switzerland-based Roche got FDA clearance for a test that is used to aid the evaluation of lipid metabolism disorders and assessment of atherosclerotic cardiovascular disease risk. The Tina-quant Lipoprotein (a) Gen.2 Molarity immunoturbidimetric assay is used for the determination of lipoprotein (a) in serum and plasma, and it is designed for use on the company's Cobas C 503 analyzers. The results are used in conjunction with clinical evaluation and other lipoprotein tests.
Roche also secured clearance for two PCR-based tests for sexually transmitted infections. The Cobas Liat CT/NG Nucleic Acid Test and Cobas Liat CT/NG/MG Test are both automated qualitative assays that are used for the detection of C. trachomatis and N. gonorrhoeae nucleic acids and the Cobas Liat CT/NG/MG is also used for the detection of M. genitalium. Both tests are used with urine samples from male patients and vaginal swab samples to aid the diagnosis of infections in symptomatic and asymptomatic patients. The tests are designed for use on Cobas Liat System analyzers.
Sunnyvale, California-based Inflammatix gained FDA clearance for its 30-minute sepsis test that is used to help identify infectious and noninfectious diseases and determine which patients are at the highest risk of disease progression. The firm's TriVerity Test System is a blood-based reverse transcription loop-mediated isothermal amplification test that is used for the automated and semi-quantitative measurement of host response gene expression levels in the assessment of patients with suspected sepsis. It is designed for use on the company's Myrna instrument.
New York City-based Paige also got the nod for the use of its digital pathology image viewing and management software with scanners from Leica and Hamamatsu. The company's FullFocus software is used to aid the review, interpretation, and management of digital slide images for primary diagnosis. It is now cleared for use with slide images that are generated from the Leica Aperio GT 450 DX scanner and Hamamatsu NanoZoomer S360MD Slide scanner system, and it was previously cleared for use with images from the Philips IntelliSite Pathology Solution Ultra Fast Scanner.
Sunnyvale, California-based Cepheid, a Danaher subsidiary, received clearances that will let the company bring two RT-PCR respiratory disease assays to its GeneXpert Xpress System. The Xpert Xpress Cov-2/Flu/RSV Plus test is used for the qualitative detection and differentiation of SARS-CoV-2, flu A/B, and RSV viral RNA, and the Xpert Xpress CoV-2 Plus test is used for the qualitative detection of SARS-CoV-2 RNA. Both tests are used with nasopharyngeal swab and anterior nasal swab samples. They were previously cleared for use on the GeneXpert instrument system.
Werfen subsidiary Instrumentation Laboratory secured 510(k) clearance for a test to help identify a patient's risk for heparin-induced thrombocytopenia. The Bedford, Massachusetts-based firm's HemosIL CL HIT-IgG (PF4-H) test is a qualitative immunoassay for the detection in 3.2 percent citrated plasma of IgG antibodies that react with complexes of platelet factor 4 and heparin. It is designed for use with the firm's ACL Top 970 CL instrument.
Italian firm Liofilchem got the agency's go-ahead for a test strip that is used to determine the susceptibility of certain bacteria to ceftobiprole. The company's MTS Ceftobiprole 0.002-32 µg/mL is a quantitative test that is used to determine the minimum inhibitory concentration of ceftobiprole against Escherichia coli, Klebsiella pneumoniae, and Staphylococcus aureus, including methicillin-resistant S. aureus. It is used with agar media, overnight incubation, and manual reading methods, with the interpretation of results at 16 to 20 hours of incubation.
Lastly, several firms also received the green light for rapid antigen tests for respiratory diseases.
Osang Healthcare's QuickFinder COVID-19/Flu Antigen Self Test and QuickFinder COVID-19/Flu Antigen Pro Test and Welllife's COVID-19/Influenza A&B Home Test and Welllife COVID-19/Influenza A&B Antigen Test are all used for the qualitative detection of differentiation of SARS-CoV-2 nucleocapsid protein antigens and flu A/B nucleoprotein antigens in anterior nasal swab samples. Access Bio's CareSuperb COVID-19 Antigen Home Test is used for the qualitative detection of the SARS-CoV-2 virus nucleocapsid protein antigen in anterior nasal swab samples from individuals with signs and symptoms of COVID-19. The tests are designed for use with self-collected samples from individuals aged 14 years and older or adult-collected samples from individuals ages 2 years and older.
For 360Dx's FDA 510(k) tracker, click here.