510(k)

The US Food and Drug Administration granted clearance to Diatron for an immunoassay that enables rapid screening for d-methamphetamine in human urine.

The test measures IgE antibodies to alpha-gal in blood. An allergy to alpha-gal can cause patients to have a severe and potentially life-threatening reaction.

The high-throughput PK7400 Automated Microplate System is designed for use in blood donor and plasma centers, as well as large reference laboratories.

Paige said that the regulatory clearance paves the way for the in vitro diagnostic use of FullFocus with additional IVD whole slide imaging scanners.

Horiba received clearance for its Yumizen C1200 CRP reagent used to measure C-reactive protein for evaluation of infections, tissue injury, and inflammatory disorders.

The system detects Zika virus IgM antibodies in human serum, potassium-EDTA plasma, potassium-EDTA venous whole blood, or fingerstick whole blood specimens.

Hologic received clearance for a change to a probe reagent in the Aptima Combo 2 assay to detect variants of Chlamydia trachomatis that have emerged recently.

Siemens Healthineers got the nod for its Advia Centaur CA 125 II Assay for detecting CA 125 to help in the management of patients with ovarian carcinoma.

The FDA cleared the point-of-care Binx io platform for the detection of chlamydia and gonorrhea in male urine specimens.