Product code PGX
- Device name
- Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation number
- 866.2680
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- 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.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260333 | LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit | Diasorin Molecular, LLC | 2026-06-15 |
| K201269 | Accula Strep A Test | Mesa Biotech, Inc. | 2020-11-09 |
| K183366 | GenePOC Strep A | Genepoc, Inc. | 2019-03-06 |
| K173653 | Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit | Alere Scarborough, Inc. | 2018-05-02 |
| K173398 | Xpert Xpress Strep A | Cepheid | 2018-04-26 |
| K172402 | ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit | Luminex Corporation | 2017-10-30 |
| K172126 | Xpert Xpress Strep A | Cepheid | 2017-09-25 |
| K162274 | Solana Strep Complete Assay | Quidel Corporation | 2016-10-25 |
| K150868 | Solana GAS Assay, Solana instrument | Quidel Corporation | 2015-06-23 |
| K141757 | ALERE I STREP A | Alere Scarborough, Inc. | 2015-03-31 |
| K143651 | Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack | Focus Diagnostics, Inc. | 2015-03-18 |
| K141338 | LIAT STREP A ASSAY | Iquum, Inc. | 2014-11-04 |
| K141173 | AMPLIVUE GAS ASSAY | Quidel Corporation | 2014-07-24 |
| DEN140005 | LYRA DIRECT STREP ASSAY | Quidel Corporation | 2014-04-16 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 20816101029079 | LIAISON NES® Group A Strep Control Swab Kit | DIASORIN MOLECULAR LLC | 2026-07-23 |
| 20816101029062 | LIAISON NES® Group A Strep | DIASORIN MOLECULAR LLC | 2026-07-23 |
| 00815381020727 | BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel Mini | BIOFIRE DIAGNOSTICS, LLC | 2024-07-26 |
| 00815381020390 | BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel | BIOFIRE DIAGNOSTICS, LLC | 2024-05-03 |
| 00840733102325 | Revogene Strep A | MERIDIAN BIOSCIENCE, INC. | 2020-07-15 |
| 00628055344179 | Revogene® Strep A | Meridian Bioscience Canada Inc | 2019-10-21 |
| 00628055344087 | GenePOC™ Strep A | GenePoc Inc | 2019-04-30 |
| 10811877010552 | ID NOW Strep A 2 | Alere Scarborough, Inc. | 2018-10-29 |
| 10811877010583 | ID NOW Strep A 2 Control Swab Kit | Alere Scarborough, Inc. | 2018-10-29 |
| 30014613336136 | Solana | DIAGNOSTIC HYBRIDS, INC. | 2018-07-23 |
| 07332940002503 | Xpert Xpress Strep A | CEPHEID | 2018-06-29 |
| 10811877010200 | Alere i Strep A 2 Control Swab Kit | Alere Scarborough, Inc. | 2018-06-28 |
| 10811877010040 | Alere i Strep A 2 | Alere Scarborough, Inc. | 2018-06-28 |
| 07332940006372 | Xpert Xpress Strep A | CEPHEID | 2018-01-29 |
| 07613336156544 | cobas Liat Strep A Script Version 1.27 | Roche Molecular Systems, Inc. | 2017-11-17 |
| 00840487101469 | ARIES® Group A Strep Assay | LUMINEX CORPORATION | 2017-11-07 |
| 00875197005646 | cobas® Strep A Quality Control Kit for use on the cobas® Liat® System | Roche Molecular Systems, Inc. | 2016-09-24 |
| 00875197005622 | cobas® Strep A Nucleic acid test for use on the cobas® Liat® System | Roche Molecular Systems, Inc. | 2016-09-24 |
| 07613336129692 | cobas® Liat® Strep A Script | Roche Molecular Systems, Inc. | 2016-09-24 |
| 20816101025576 | Simplexa™ Group A Strep Positive Control Pack | DIASORIN MOLECULAR LLC | 2016-09-22 |
| 20816101025569 | Simplexa™ Group A Strep Direct | DIASORIN MOLECULAR LLC | 2016-09-22 |
| 30014613336082 | Solana | QUIDEL CORPORATION | 2016-09-15 |
| 30014613312123 | AmpliVue | QUIDEL CORPORATION | 2016-09-15 |
| 30014613311126 | Lyra | QUIDEL CORPORATION | 2016-09-15 |
| 10811877010866 | Alere™ i Strep A Control Swab Kit | Alere Scarborough, Inc. | 2016-09-03 |
| 10811877010859 | Alere™ i Strep A | Alere Scarborough, Inc. | 2016-09-03 |