Roche Diagnostics got the nod for its Elecsys Anti-HAV II test for the detection of total antibodies — IgG and IgM — to the hepatitis A virus.
The clearance of the Binx io CT/NG test marks a milestone for the Johns Hopkins University group that funds early-stage development of rapid STI testing.
The FDA cleared the system, comprising a blood collection device and associated test to measure long-term glucose levels in patients with diabetes.
The clearance marks the first time that the tests have been indicated to follow a new paradigm in which two enzyme immunoassay tests can be conducted concurrently or sequentially, the FDA said.
Abbott said that its Afinion HbA1c assay used to diagnose diabetes could eventually be made available in physicians' offices through a CLIA waiver.
Included in the 510(k) clearances was one for AMS Diagnostics' Liasys 600 Electrolyte Measurement System for measuring sodium, chloride, and potassium in human serum.
The Frederick, Maryland-based firm has received regulatory clearance for a multiplexed array-based assay after more than 15 years in development.
The test, cleared for use with Quidel’s Triage MeterPro instrument, uses monoclonal antibodies that are specific for the metabolites of nine drug classes.
Applied BioCode said that it now has access to higher volume laboratories that use the Roche MagNa Pure 96 System for sample extraction.
The diagnostic can now be used to identify patients with head and neck squamous cell carcinoma who may benefit from first-line treatment with Keytruda.