Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
FDA product code PGX · Class II (moderate risk) · 21 CFR 866.2680 · Microbiology
An in vitro diagnostic test for the detection of Group A, C and G beta hemolytic Streptococcus in throat swab specimens from symptomatic patients.
14510(k) clearances
0PMA approvals
4recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260047 | cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas…PGX · Traditional | Roche Molecular Systems, Inc. | 08/28/2026SE |
| K260333 | LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab KitPGX · Dual Track | Diasorin Molecular, LLC | 06/15/2026SE |
| K201269 | Accula Strep A TestPGX · Dual Track | Mesa Biotech, Inc. | 11/09/2020SE |
| K183366 | GenePOC Strep APGX · Traditional | Genepoc, Inc. | 03/06/2019SE |
| K173653 | Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab KitPGX · Dual Track | Alere Scarborough, Inc. | 05/02/2018SE |
| K173398 | Xpert Xpress Strep APGX · Dual Track | Cepheid | 04/26/2018SE |
| K172402 | ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File KitPGX · Traditional | Luminex Corporation | 10/30/2017SE |
| K172126 | Xpert Xpress Strep APGX · Traditional | Cepheid | 09/25/2017SE |
| K162274 | Solana Strep Complete AssayPGX · Traditional | Quidel Corporation | 10/25/2016SE |
| K150868 | Solana GAS Assay, Solana instrumentPGX · Traditional | Quidel Corporation | 06/23/2015SE |
| K141757 | Alere I Strep aPGX · Traditional | Alere Scarborough, Inc. | 03/31/2015SE |
| K143651 | Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control PackPGX · Traditional | Focus Diagnostics, Inc. | 03/18/2015SE |
| K141338 | Liat Strep a AssayPGX · Traditional | Iquum, Inc. | 11/04/2014SE |
| K141173 | Amplivue Gas AssayPGX · Traditional | Quidel Corporation | 07/24/2014SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0216-2024 Class II | Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD,pipettes packaged in Strep A test may fail to dispense an adequate sample volume which could result in… | Cepheid | 04/24/2023Open, Classified |
| Z-0215-2024 Class II | Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Onlypipettes packaged in Strep A test may fail to dispense an adequate sample volume which could result in… | Cepheid | 04/24/2023Open, Classified |
| Z-2286-2019 Class II | ARIES Group A Strep Assay , REF 50-10041, UDI # 00840487101469Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back… | Luminex Corporation | 02/20/2019Open, Classified |
| Z-1274-2016 Class I | Simplexa Group A Strep Direct (MOL2850) with Direct Amplification Disc (MOL1451…Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa HSV 1 & 2… | Focus Diagnostics Inc | 02/10/2016Terminated |