The firm said that its rapid flu detection platform helps reduce the subjectivity of interpreting test results and can be used in a broad range of healthcare settings.
The platform enables the assessment of hemoglobin levels at the point of care and quantitatively measures hemoglobin in capillary or venous whole blood.
The FDA granted de novo classification for eight probes for detecting chromosomal rearrangements reported in acute myeloid leukemia and myelodysplastic syndromes.
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.
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.
