NEW YORK – The US Food and Drug Administration in February granted 510(k) marketing clearances for digital pathology software, an expanded bacterial infection panel, and multiple immunoassays that are used for the diagnosis and monitoring of serious diseases.
Danaher's Beckman Coulter got the go-ahead for an immunoassay that is used to help healthcare providers identify and treat patients who have had a heart attack and patients who have progressive muscle diseases. The firm's Access CK-MB assay is used for the quantitative determination of creatine kinase-MB isoenzyme in serum and plasma to aid the diagnosis and treatment of myocardial infarction and muscle diseases such as Duchenne-type muscular dystrophy. The assay is designed for use on the firm's Access Immunoassay Systems analyzers.
The firm also received clearance for an immunoassay that is used to measure sex hormone binding globulin levels for the assessment of androgen disorders. The Access SHBG assay is used for the quantitative determination of those concentrations in serum and plasma, and it is designed for use on the firm's Access Immunoassay Systems analyzers.
Roche picked up clearance for an immunoassay that is used for the quantitative determination of methotrexate in serum and plasma. The Basel, Switzerland-based firm's Online TDM Methotrexate enzyme immunoassay is designed for use on the Cobas C 503 Clinical Chemistry Analyzer.
Meanwhile, Philadelphia-based Proscia got FDA 510(k) clearance for its software that is used to aid the viewing and management of whole-slide images in digital pathology. The firm's Concentriq Dx software is used for the viewing, interpretation, and management of digital images that are used for the primary diagnosis of cancer, and the firm secured clearance for the software for use with the Hamamatsu NanoZoomer S360MD Slide scanner and JVC JD-C240BN01A monitor.
Boston-based biotech startup Selux nabbed FDA clearance for the firm's Positive Blood Culture Separator that expands the sample types that can be used with the Selux Next Generation Phenotyping System for antimicrobial susceptibility testing. The PBC Separator was cleared for use with the firm's testing system for the quantitative or qualitative determination of antimicrobial susceptibility among clinically significant aerobic microorganisms.
Also, French diagnostics firm Sebia got 510(k) clearance in February for modifications to a pair of previously cleared immunoassays that had been used to aid the diagnosis of multiple myeloma and AL amyloidosis. The tests can now also be used for the monitoring of both conditions. The firm's FLC Kappa and FLC Lambda ELISAs are used for the quantitative determination of Kappa and Lambda free light chains in serum from adults. The modified clearance also extends the shelf life of the assays and controls.
T2 Biosystems received the nod for a modification to the firm's previously cleared T2Bacteria Panel that is used for the detection of bacterial species in patients with signs and symptoms of bloodstream infections. The molecular assay can now be used for the detection of Acinetobacter baumannii along with the previous targets of Enterococcus faecium, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Staphylococcus aureus.
ARK Diagnostics got a green light for an immunoassay that is used to identify levetiracetam concentrations in the blood of patients who are being treated with the antiseizure drug. The Fremont, California-based firm's ARK Levetiracetam II Assay is used for the quantitative determination of levetiracetam in serum or plasma on automated clinical chemistry instruments.
Lastly, Chinese firm Shanghai Accurature Diagnostics also nabbed FDA 510(k) clearance for prescription-use and over-the-counter immunoassays that are used to identify the consumption of drugs of abuse. The firm's prescription-use Multi-drug Urine Test Cup and Multi-drug Test Dip Card and its over-the-counter Accurature Multi-drug Urine Test Cup and Accurature Multi-drug Urine Test Dip Card are used for the simultaneous qualitative detection in urine of analytes for amphetamine, secobarbital, buprenorphine, oxazepam, cocaine, methylenedioxymethamphetamine, methamphetamine, morphine, methadone, oxycodone, phencyclidine, and marijuana.
For 360Dx's FDA 510(k) tracker, click here.