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 also cleared a 23andMe genetic health risk report for a syndrome associated with a higher risk of developing hereditary colorectal cancer.
The assay is designed to detect ribosomal RNA from four clinically relevant Babesia species and runs on the company's Procleix Panther system.
The FDA said that Terrific Care/Medex Supply distributed certain Roche Diagnostics test strip lots in the US even though domestic sales had been stopped due to safety concerns.
The test, for use on the Claros I Analyzer, leverages microfluidic technology in a disposable test cassette to provide results in 10 minutes or less.
The infusion set is designed to work with the company's Kurin Lock system for the prevention of blood collection contamination and false positives.
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 clearance enables 23andMe to report on the two most common variations in the MUTYH gene influencing MAP, which increases risk of CRC development.