NEW YORK – The US Food and Drug Administration last month granted 510(k) marketing clearances for a test to help determine pregnant patients' risk of preeclampsia, several respiratory disease tests, and a digital pathology whole-slide scanning and viewing system, among others.
Roche secured FDA clearance for a pair of assays to help assess the risk of a pregnant woman developing preeclampsia hypertensive disorders within the two weeks following testing. The Basel, Switzerland-based firm's Elecsys sFlt-1 and Elecsys PlGF electrochemiluminescence immunoassays are used together for the quantitative determination in serum of the soluble fms-like tyrosine kinase-1/placental growth factor (sFlt-1/PlGF) ratio. The tests are designed for use with the company's Cobas E 411 immunoassay analyzer, with a turnaround time of 18 minutes.
Roche also gained an expanded clearance for an RT-PCR test for SARS-CoV-2 infection to include the testing of asymptomatic patients. The Cobas SARS-CoV-2 Qualitative test is used for detecting SARS-CoV-2 nucleic acids in nasopharyngeal swab samples, and it is designed for use on the company's Cobas 5800/6800/8800 systems.
Marlborough, Massachusetts-based Hologic gained 510(k) clearance for a molecular SARS-CoV-2 assay that had been available since 2020 through an Emergency Use Authorization. The Aptima SARS-CoV-2 Assay is a transcription-mediated amplification assay that is used for the quantitative detection of SARS-CoV-2 RNA in nasopharyngeal and nasal swab samples from patients with signs and symptoms of respiratory tract infection. The test is designed for use on Hologic's Panther instrument.
Abbott secured 510(k) clearance for an RT-PCR-based respiratory assay for the detection and differentiation of RNA sequence of SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus. The test is performed with nasopharyngeal swab samples that are collected from patients with signs and symptoms of respiratory tract infection, and it is designed for use with the company's automated Alinity M System.
The Abbott Park, Illinois-based firm also got the FDA's go-ahead for its BinaxNow COVID-19 Antigen Self-Test, which is a lateral flow immunoassay that is used for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in anterior nasal swab samples from individuals with signs and symptoms of COVID-19. The test received FDA Emergency Use Authorization in 2020, and it has been available without a prescription since 2021.
Abbott also received an updated clearance for its Alinity H-Series System integrated hematology analyzer and slide maker stainer. The company is updating the instrument's software to correct falsely increased basophil measurements due to misclassification of lymphocytes as basophils in some blood samples. The analyzer is used to provide complete blood count and six-part white blood cell differential for normal and abnormal cells.
Lastly, Abbott also secured clearance for its Calcium2 automated clinical chemistry assay that is used for the quantitative determination of calcium in serum, plasma, or urine to aid the diagnosis and treatment of parathyroid disease, bone diseases, chronic renal disease, and intermittent muscular contractions or spasms. The test is designed for use on the Architect E System.
Sunnyvale, California-based Cepheid secured FDA 510(k) clearance for an update to a molecular blood test that is used to detect mutations to aid the diagnosis of thrombophilia. The Xpert FII & FV qualitative genotyping test is used for the detection of Factor II and Factor V alleles, and it is designed for use on the company's PCR-based GeneXpert Instrument Systems. The update removes a statement from the labeling that the test's performance had not been evaluated with samples from pediatric patients. The test's performance has been evaluated in a method comparison study.
Cepheid also received the agency's go-ahead for an update to a PCR-based test for toxigenic Clostridium difficile strains to allow the performance of the test with more of the company's instruments. The firm's Xpert C. difficile/Epi test is used for the qualitative detection of toxin B gene sequences for the presumptive identification of 027/NAP1/BI strains of toxigenic C. difficile in stool specimens from patients with suspected infection. The recent clearance allows the performance of the test on the firm's GeneXpert Infinity System that includes the GeneXpert Infinity-48s and GeneXpert Infinity-80 instruments and the GeneXpert Xpertise software. The test was previously cleared for use with the GeneXpert Dx System and GeneXpert System with Touchscreen.
Waltham, Massachusetts-based Thermo Fisher Scientific got the green light for three growth-based quantitative antimicrobial susceptibility tests. The company's Sensititre YeastOne Susceptibility System with Micafungin in the Dilution Range of 0.008-16 µg/mL is used to determine the susceptibility of Candida species to the antifungal drug micafungin. Meanwhile, the firm's Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.12-32 µg/mL is used to determine the susceptibility of H. influenzae and S. pneumoniae and other Streptococcus species to the antibiotic linezolid. The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Penicillin in the dilution range of 0.015-32 µg/mL is used to determine the susceptibility of the same organisms to penicillin.
Epredia, which is the precision cancer diagnostics subsidiary of PHC Holdings, secured 510(k) clearance for a digital pathology system that is used for the creation, viewing, and management of whole-slide images. The E1000 Dx Digital Pathology Solution is comprised of the E1000 Dx Digital Pathology Scanner, scanner software, image management system, and viewing software along with the Barco MDPC-8127 display. The system has a 1,000-slide capacity when used with Sakura Tissue-Tek 20-Slide Baskets, and it uses a machine learning-developed model to detect the presence and location of tissue samples on glass slides.
San Jose, California-based Visby Medical got 510(k) clearance and CLIA waiver for a molecular test to aid the identification of flu A/B and SARS-CoV-2 infections. The Visby Medical Respiratory Health Test is a qualitative RT-PCR assay that is used for the detection and differentiation of SARS-CoV-2, influenza A, and influenza B RNA in nasopharyngeal swab and anterior nasal swab samples from patients with signs and symptoms of respiratory tract infection.
Werfen subsidiary Biokit nabbed clearance for an immunoassay that is used to aid the diagnosis of herpes simplex virus type 2 infection. The Architect HSV-2 IgG assay is used for the qualitative detection of IgG antibodies to HSV-2 in serum and plasma from sexually active adults or expectant mothers, and it is designed for use on Abbott's Architect I System.
Lastly, CytoChip gained 510(k) marketing clearance and CLIA waiver for a handheld hematology analyzer and complete blood count test. The Irvine, California-based firm's CitoCBC system is used to report complete blood count parameters and five-part white blood cell differential counts and percentages.
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