FDA product code PGX: Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
PGX is the FDA product code for groups a, c and g beta-hemolytic streptococcus nucleic acid amplification system. It is a Class II device, regulated under 21 CFR 866.2680 and reviewed by the Microbiology panel. FDA has cleared 14 510(k) submissions under PGX, 2 in the last five years, from 10 different applicants. The average 510(k) review took 135 days (median 112); 183 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 4 recalls for PGX devices, 2 initiated in the last five years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System |
| Device class | Class II |
| Regulation | 21 CFR 866.2680 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for PGX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 78 |
| 2018 | 2 | 166 |
| 2019 | 1 | 92 |
| 2020 | 1 | 181 |
| 2026 | 2 | 183 |
Compare with all 510(k) review times · Search every PGX clearance
Top PGX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Quidel Corporation | 3 | 2016-10-25 |
| Alere Scarborough, Inc. | 2 | 2018-05-02 |
| Cepheid | 2 | 2018-04-26 |
| Roche Molecular Systems, Inc. | 1 | 2026-08-28 |
| Diasorin Molecular, LLC | 1 | 2026-06-15 |
5 more applicants have PGX clearances. See the full list in Caduvo.
Most recent PGX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260047 | Roche Molecular Systems, Inc. | cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas Strep A Quality Control Kit (07402678190) | 2026-08-28 | 233 |
| K260333 | Diasorin Molecular, LLC | LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit | 2026-06-15 | 133 |
| K201269 | Mesa Biotech, Inc. | Accula Strep A Test | 2020-11-09 | 181 |
| K183366 | Genepoc, Inc. | GenePOC Strep A | 2019-03-06 | 92 |
| K173653 | Alere Scarborough, Inc. | Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit | 2018-05-02 | 155 |
Recalls for PGX devices
4 product recalls in 3 recall events; 2 initiated in the last five years and 3 still open. Most recent: 2023-04-24.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2023 | 2 |
Frequently asked questions
What is FDA product code PGX?
PGX is the FDA product code for groups a, c and g beta-hemolytic streptococcus nucleic acid amplification system. It is a Class II device, regulated under 21 CFR 866.2680 and reviewed by the Microbiology panel.
What device class is PGX?
Class II, regulation 21 CFR 866.2680. Typical premarket route: 510(k).
How long does a 510(k) take for product code PGX?
Across 14 cleared submissions the average was 135 days from receipt to decision (median 112).
Which companies have the most PGX clearances?
Quidel Corporation (3); Alere Scarborough, Inc. (2); Cepheid (2); Roche Molecular Systems, Inc. (1); Diasorin Molecular, LLC (1).
Have PGX devices been recalled?
Yes: 4 product recalls across 3 recall events; the most recent began 2023-04-24.
Next steps
- Run an FDA pathway report with predicate devices for product code PGX
- Run a recall and safety report across every PGX manufacturer
- Watch product code PGX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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