DeviceClearance

Product code PEU— Microbiology

XPERT MTB/RIF ASSAY

Classification name
System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen
Device class
Class 2
Regulation
21 CFR 866.3373
Advisory panel
Microbiology
Total cleared
2
First cleared
Most recent

FDA classification definition

“The [test] is intended for use with specimens from patients for whom there is clinical suspicion of tuberculosis (TB) and who have received no antituberculosis therapy, or less than 3 days of therapy. This [test] is intended as an aid in the diagnosis of pulmonary tuberculosis when used in conjunction with clinical and other laboratory findings.”

— U.S. Food and Drug Administration, device classification record for product code PEU under 21 CFR 866.3373, via openFDA

Market context for product code PEU

FDA has cleared 2 devices under product code PEU between 2013 and 2015, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PEU

Recent clearances under product code PEU

Data sourced from openFDA. This site is unofficial and independent of the FDA.