NEW YORK – The US Food and Drug Administration cleared in vitro diagnostic tests and systems in January from Siemens Healthineers, Diasorin, Thermo Fischer Scientific, and others, according to the agency's website.
Siemens Healthineers received 510(k) clearance for the Advia Centaur Total IgE assay to detect total IgE in serum and plasma running on its Advia Centaur, Advia Centaur XP, and Advia Centaur XPT systems. The test is a two-site sandwich immunoassay that uses direct chemiluminometric technology.
DiaSorin got the nod for the Liaison Lyme Total Antibody Plus assay and Liaison Lyme Total Antibody Plus Control Set. The assay uses chemiluminescence to detect lgG and IgM antibodies to Borrelia burgdorferi in human serum and plasma samples.
It is used on samples from patients with symptoms of Lyme disease. Positive or equivocal results should be supplemented by testing with a standardized Western blot procedure, and the new test must be performed on Diasorin's Liaison XL analyzer, the FDA said. Meanwhile, the Liaison Lyme Total Antibody Plus Control Set are assayed quality control samples used to monitor the performance of the Liaison Lyme Total Antibody Plus assay.
Meantime, the FDA cleared Thermo Fisher Scientific's Sensititre 20- to 24-hour Haemophilus influenzae/Streptococcus pneumoniae minimum inhibitory concentration or breakpoint susceptibility system with lefamulin (Nabriva's Xenleta), in the dilution range of 0.008 to 16 µg/mL.
Shenzhen Bioeasy Biotechnology was granted clearance for the Bioeasy Multi-Drug Test Cup, which consists of competitive binding, lateral flow immunochromatographic assays for the detection of drugs in human urine at specified cutoff concentrations. The drugs are amphetamine, oxazepam, cocaine, marijuana, methamphetamine, morphine, oxycodone, secobarbital, buprenorphine, methylenedioxy-methamphetamine, phencyclidine, methadone, nortriptyline, and d-propoxyphene.
Additionally, Applied BioCode received 510(k) clearance for its BioCode Respiratory Pathogen Panel for use on the BioCode MDx-3000 system; Beckman Coulter received clearance for its Access PCT assay; and DNA Genotek, a wholly owned subsidiary of OraSure Technologies, received clearance for its Oragene Dx sample collection kits.