cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas Strep A Quality Control Kit (07402678190)
FDA 510(k) K260047 · Roche Molecular Systems, Inc.
510(k) numberK260047
Submission
- Device name
- cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas Strep A Quality Control Kit (07402678190)
- Applicant
- Roche Molecular Systems, Inc.
Pleasanton, CA, US - Received
- January 7, 2026
- Decision date
- August 28, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PGX – Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.2680
- Specialty
- 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.
Other 510(k)s with product code PGX
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|---|---|---|---|
| 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 |
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| 510(k) | Device | Decision |
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| K260045 | cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190); cobas®…OZN · Traditional | 08/28/2026SE |
| K260021 | cobas® BV/CVPQA · Traditional | 07/16/2026SE |
| K260917 | cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the…QEP · Traditional | 07/08/2026SE |
| K253759 | cobas liat CT/NG/MG nucleic acid testQEP · Dual Track | 05/15/2026SE |
| K253756 | cobas liat CT/NG nucleic acid testQEP · Dual Track | 05/15/2026SE |
| K243753 | cobas liat Bordetella panel nucleic acid testOZZ · Dual Track | 11/20/2025SE |
| K252484 | cobas HCVMZP · Traditional | 11/03/2025SE |
| K252481 | cobas CMVPAB · Traditional | 11/03/2025SE |
| K243455 | cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 SystemsQOF · Traditional | 07/31/2025SE |
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Questions and answers
When was cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas Strep A Quality Control Kit (07402678190) cleared by the FDA?
cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas Strep A Quality Control Kit (07402678190) (K260047) received a 510(k) decision of Substantially Equivalent on August 28, 2026, 233 days after the submission was received.
What is the product code of K260047?
The FDA product code is PGX – Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System, a Class II (moderate risk) device regulated under 21 CFR 866.2680.