The Optigen AP 3600 can process up to 100 panels, or as many as 3,600 individual allergen results, in one day, and allows for true walk-away time, the firm said.
BioMérieux received clearance for its Vitek 2 gram-negative susceptibility card as a test used to determine the antimicrobial susceptibility of certain aerobic bacilli.
IL said that the rapid basic metabolic panel is designed for testing at the point of care, primarily in hospital emergency departments and clinical laboratories.
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 infusion set is designed to work with the company's Kurin Lock system for the prevention of blood collection contamination and false positives.
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.
The firm had also applied for marketing clearance for its gram negative and fungal pathogen panels in October.
The enteric panel detects the viral cause of infectious diarrhea symptoms including norovirus, rotavirus, adenovirus, human astrovirus, and sapovirus.
The proposal establishes procedures and criteria for the de novo classification of medical devices that would clarify requirements for submission and review.