NEW YORK – The US Food and Drug Administration cleared in vitro diagnostic tests and systems in July from Becton Dickinson, Siemens Healthineers, Abbott, Roche, and others, according to the agency's website.
Siemens Healthineers received clearance for the Atellica CH Amylase 2 assay running on the firm's Atellica CH Analyzer to measure amylase activity in serum, plasma, and urine and to diagnose and monitor acute pancreatitis.
The firm also got the go-ahead for its Advia Centaur Zika test, Advia Centaur Zika Ab test, Advia Centaur Zika IgM test, Advia Centaur Zika Ab quality control, and Advia Centaur Zika IgM quality control. The Advia Centaur Zika test detects immunoglobulin M antibodies to the Zika virus in serum and plasma specimens using the Siemens Advia Centaur XP and Advia Centaur XPT systems.
Becton Dickinson got the FDA nod for the BD Phoenix Automated Microbiology System – GN Ceftaroline (0.0156-4 µg/mL). The fully automated short-term incubation cycle antimicrobial susceptibility system does rapid identification and provides quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of most gram negative aerobic and facultative anaerobic bacteria in enterobacteriaceae and non-enterobacteriaceae families.
Hycor Biomedical received clearance for its Noveos Specific IgE Assay, Capture Reagent House Dust Mite D002, Dermatophagoides Farina. The Noveos Specific IgE Assay measures allergen specific immunoglobulin E (IgE) in human serum, running on the firm's Noveos Immunoassay Analyzer, during the diagnosis of IgE-mediated allergic disorders.
Abbott received a special 510(k) clearance for a software modification to the ID Now Influenza A & B 2 test. Previously called the Alere i, the rapid multiplex nucleic acid assay is used for the detection and differentiation of influenza A and influenza B in patients presenting with signs and symptoms of respiratory infection. The clearance permits marketing of the ID Now instrument and assay with a software modification that, according to the FDA, was made to "optimize recognition of partial [or] non-dispense of sample into the test base that [resulted] in a high baseline and to prevent false invalids due to system noise in the normalization window." No changes were made to the chemistry of the assay, the FDA said.
Roche Diagnostics also received a special 510(k) clearance for a point-of-care influenza test. The clearance relates to a software modification to its Cobas Influenza A/B test running on the Cobas Liat point-of-care system. The real-time RT-PCR assay is used for the rapid qualitative detection and discrimination of influenza A and Influenza B virus RNA in specimens from patients with symptoms of respiratory infection. The Cobas Liat analyzer consists of an instrument and preloaded software for running tests and viewing the results. According to the FDA, the software change consists of updates to the "result interpretation concept logic and new checks and cut-offs implemented to address results erroneously reported as invalid and [to] prevent false positives."
Healthy.io got FDA clearance for its ACR LAB Urine Analysis Test System consisting of a smartphone application, a color board, and its ACR reagent strips. The system does semi-quantitative detection of albumin and creatinine in urine. The FDA cleared the test for use by healthcare professionals at the point of care in the measurement of kidney function.
The FDA also cleared four enzyme immunoassay tests to diagnose Lyme disease, which was developed by Branchburg, New Jersey-based Zeus Scientific, and the agency approved use of the Abbott Alinity s System to conduct screening in US blood and plasma centers.