The FDA also cleared a 23andMe genetic health risk report for a syndrome associated with a higher risk of developing hereditary colorectal cancer.
The FDA granted de novo classification for eight probes for detecting chromosomal rearrangements reported in acute myeloid leukemia and myelodysplastic syndromes.
The kit is for quantitatively measuring the percent of glycated hemoglobin, total cholesterol, high-density lipoprotein, triglycerides, and glucose.
The FDA said it is the first test authorized to test for M. genitalium, a slow-growing bacteria that is difficult to detect with traditional laboratory methods.
The clearance enables 23andMe to report on the two most common variations in the MUTYH gene influencing MAP, which increases risk of CRC development.
Under a separate initative, the FDA would give device makers the option of demonstrating substantial equivalence to performance criteria, rather than to a predicate device.
GenMark got clearance for an assay to detect fungal pathogens from blood cultures of patients with suspected bloodstream infections, and it received clearance for a bacterial assay.
The molecular test detects and differentiates Bordetella pertussis and Bordetella parapertussis from fresh and frozen nasopharyngeal swab samples.
The Erytra Eflexis is a fully automated benchtop analyzer for pretransfusion compatibility testing that facilitates multiple lab configurations and features real random access.
The infrared spectroscopy-based analyzer is designed to quantitatively measure the concentration of fat, carbohydrate, and protein in human milk.