PGXClass II

Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System

21 CFR 866.2680 / Microbiology

PGX is the FDA product code for Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System, a class II device type, regulated under 21 CFR 866.2680. FDA's definition for this code reads: "An in vitro diagnostic test for the detection of Group A, C and G beta hemolytic Streptococcus in throat swab specimens from symptomatic patients". As of 2026-09-10, FDA records hold 15 510(k) clearances under this code, the most recent dated 2026-08-28, and 4 recalls.

Classification record

Product code: PGX
Device name: Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
FDA 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.
Regulation: 21 CFR 866.2680
Device class: Class II
Review panel: Microbiology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 15
Ingested recalls: 4

Clearances, product code PGX

By decision year

15 clearances under product code PGX with a decision year between 2014 and 2026, 2014 the highest year at 3.

Show the numbers

510(k) clearances under FDA product code PGX by decision year
Year	Clearances
2014	3
2015	3
2016	1
2017	2
2018	2
2019	1
2020	1
2026	2

Applicants with the most clearances

Product code PGX

Applicants holding the most 510(k) clearances under product code PGX
Applicant	Clearances
Ortho-Clinical Diagnostics, Inc.	4
Alere Scarborough, Inc.	2
Cepheid	2
DiaSorin Molecular LLC	2
Genepoc, Inc.	1
Iquum, Inc.	1
Luminex Corporation	1
Mesa Biotech, Inc.	1
Roche Molecular Systems, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 14 companies shown, in name order