DeviceClearance

Product code PGX— Microbiology

Xpert Xpress Strep A

Classification name
Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
Device class
Class 2
Regulation
21 CFR 866.2680
Advisory panel
Microbiology
Total cleared
15
First cleared
Most recent

FDA classification definition

“An in vitro diagnostic test for the detection of Group A, C and G beta hemolytic Streptococcus in throat swab specimens from symptomatic patients.”

— U.S. Food and Drug Administration, device classification record for product code PGX under 21 CFR 866.2680, via openFDA

Market context for product code PGX

FDA has cleared 15 devices under product code PGX between 2014 and 2026, filed by 10 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 PGX

Recent clearances under product code PGX

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