NEW YORK – The US Food and Drug Administration in October granted 510(k) marketing clearances to molecular tests for infectious diseases, antimicrobial susceptibility tests, and a test for coagulation disorders, among others.
Qiagen got the agency's go-ahead for a pair of syndromic panels that are used to identify the causes of respiratory diseases and the causes of meningitis and encephalitis. The firm's QiaStat-Dx Respiratory Panel Mini is a multiplex qPCR assay that is used for the qualitative detection of nucleic acids from SARS-CoV-2, flu A/B, and respiratory syncytial virus in nasopharyngeal swab samples from patients with signs and symptoms of respiratory tract infection.
The QiaStat-Dx Meningitis/Encephalitis (ME) Panel is a multiplex qPCR-based assay for the simultaneous detection and identification of bacterial, viral, and fungal targets in cerebrospinal fluid samples from individuals with signs and symptoms of meningitis or encephalitis. The results are used for the identification of enterovirus, Escherichia coli K1, Haemophilus influenzae, Listeria monocytogenes, encapsulated Neisseria meningitidis, Streptococcus agalactiae, S. pneumoniae, S. pyogenes, and Cryptococcus neoformans or C. gattii, which are not differentiated in the results.
Both tests are designed for use with the QiaStat-Dx Analyzer 1.0.
Danaher company Cepheid secured clearance for a test for Staphylococcus aureus and methicillin-resistant S. aureus to aid the prevention and control of infections in healthcare settings. The Xpert SA Nasal Complete test is a qualitative qPCR test for the detection of target nucleic acids in nasal swab samples from patients who are at risk of nasal colonization, and the test is designed for use with the firm's GeneXpert instruments.
Waltham, Massachusetts-based Thermo Fisher Scientific received the agency's go-ahead for two test powder products that are used for clinical susceptibility determination of fastidious isolates. The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Meropenem in the dilution range of 0.015-32 µg/ml is used to test for meropenem susceptibility among Streptococcus pneumoniae, S. agalactiae, S. pyogenes, viridans group streptococci, and Haemophilus influenzae. The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Ceftriaxone in the dilution range of 0.015-2 µg/ml is used to test for ceftriaxone susceptibility among S. pneumoniae, S. pyogenes, viridans group streptococci, and H. influenzae.
Thermo Fisher subsidiary Microgenics, meanwhile, got the nod for an enzyme immunoassay that is used to identify consumption of certain drugs of abuse. The Fremont, California-based business' DRI Ecstasy Plus Assay is used for the qualitative or semiquantitative detection in urine of the consumption of ecstasy drugs. The company said that the test results should be considered preliminary, and a more specific chemical method must be used for confirmation.
Beckman Coulter received clearance for an immunoassay that is used to aid the diagnosis of acute, recent, or reactivated Toxoplasma gondii infection. The Brea, California-based firm's Access Toxo IgM II is used for the qualitative detection of T. gondii-specific IgM antibodies in serum and plasma samples.
Siemens Healthineers gained clearance for an automated chromogenic test for coagulation disorders. The Erlangen, Germany-based firm's Innovance Anti-Xa assay is used with the Innovance Heparin Calibrator for the quantitative determination of unfractionated heparin and low-molecular weight heparin activity in plasma from patients who are undergoing anticoagulant therapy, and the assay is used with Innovance Apixaban Standard for the quantitative determination of the concentration of apixaban in plasma from patients who are undergoing anticoagulant therapy with apixaban when those patients are bleeding or at risk of bleeding or they have conditions affecting pharmacokinetics. The test can be performed with Siemens' BCS XP, CS-2500, CS-5100, and CA-660 systems.
Santa Barbara, California-based Affinity Biosensors got an updated FDA 510(k) clearance that allows for the use of the LifeScale Gram Negative Kit to test for susceptibility to a broader range of antimicrobial agents in positive blood culture samples that have been confirmed with Gram stain to contain Gram-negative bacilli. The firm received in April clearance for the use of the test with the company's LifeScale AST system for susceptibility testing involving six types of antimicrobials, and the firm sought the updated clearance to remove limitations on testing involving certain antimicrobial-organism combinations as well as to allow testing for susceptibility to another eight types of antimicrobials.
UK-based Immunodiagnostics Systems got the green light for a test to aid the identification of patients with disorders involving androgen hormones. The IDS-iSYS Free Testosterone assay is used for the quantitative determination of free testosterone in serum and plasma for the diagnosis and treatment of disorders including hypogonadism, impotence, hirsutism, and virilization due to tumors, polycystic ovaries, and androgenital syndromes.
Lastly, Cincinnati, Ohio-based Devicor Medical Products got the go-ahead for an automated core needle biopsy system. The firm's Mammotome AutoCore Single Insertion Core Biopsy System is used for the acquisition of tissue samples from breast or lymph nodes for the diagnostic analysis of breast abnormalities.
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