DeviceClearance

Product code POC— Microbiology

Xpert Carba-R

Classification name
System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen
Device class
Class 2
Regulation
21 CFR 866.1640
Advisory panel
Microbiology
Total cleared
4
First cleared
Most recent

FDA classification definition

“To detect the presence of genetic markers of antimicrobial resistance by testing directly from clinical specimens using nucleic acid amplification technology.”

— U.S. Food and Drug Administration, device classification record for product code POC under 21 CFR 866.1640, via openFDA

Market context for product code POC

FDA has cleared 4 devices under product code POC between 2016 and 2026, filed by 2 applicant companies. 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 POC

Recent clearances under product code POC

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