PGX — Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System Class II
FDA product code PGX covers "Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System", a Class II medical device regulated under 21 CFR 866.2680. Submissions are reviewed by the Microbiology panel. At least 14 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PGX
- Device Class
- Class II
- Regulation Number
- 866.2680
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260333 | diasorin molecular | LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit | June 15, 2026 |
| K201269 | mesa biotech | Accula Strep A Test | November 9, 2020 |
| K183366 | genepoc | GenePOC Strep A | March 6, 2019 |
| K173653 | alere scarborough | Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit | May 2, 2018 |
| K173398 | cepheid | Xpert Xpress Strep A | April 26, 2018 |
| K172402 | luminex corporation | ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit | October 30, 2017 |
| K172126 | cepheid | Xpert Xpress Strep A | September 25, 2017 |
| K162274 | quidel corporation | Solana Strep Complete Assay | October 25, 2016 |
| K150868 | quidel corporation | Solana GAS Assay, Solana instrument | June 23, 2015 |
| K141757 | alere scarborough | ALERE I STREP A | March 31, 2015 |
| K143651 | focus diagnostics | Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack | March 18, 2015 |
| K141338 | iquum | LIAT STREP A ASSAY | November 4, 2014 |
| K141173 | quidel corporation | AMPLIVUE GAS ASSAY | July 24, 2014 |
| DEN140005 | quidel corporation | LYRA DIRECT STREP ASSAY | April 16, 2014 |