Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
The Groups A, C, and G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System is an in vitro diagnostic test for the qualitative detection of Group A, C, and G beta-hemolytic Streptococcus in throat swab specimens from symptomatic patients. It is an FDA Class 2 device regulated under 21 CFR 866.2680, requiring 510(k) premarket notification, within the Microbiology (MI) specialty. The product code is PGX. This device is not an implant and is not life-sustaining.
Basic Information
- Product Code
- PGX
- Device Class
- FDA class 2
- Regulation Number
- 866.2680
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 14 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K260333 | LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit | Jun 15, 2026 | Substantially Equivalent | Diasorin Molecular, LLC |
| K201269 | Accula Strep A Test | Nov 09, 2020 | Substantially Equivalent | Mesa Biotech, Inc. |
| K183366 | GenePOC Strep A | Mar 06, 2019 | Substantially Equivalent | Genepoc, Inc. |
| K173653 | Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit | May 02, 2018 | Substantially Equivalent | Alere Scarborough, Inc. |
| K173398 | Xpert Xpress Strep A | Apr 26, 2018 | Substantially Equivalent | Cepheid |
| K172402 | ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit | Oct 30, 2017 | Substantially Equivalent | Luminex Corporation |
| K172126 | Xpert Xpress Strep A | Sep 25, 2017 | Substantially Equivalent | Cepheid |
| K162274 | Solana Strep Complete Assay | Oct 25, 2016 | Substantially Equivalent | Quidel Corporation |
| K150868 | Solana GAS Assay, Solana instrument | Jun 23, 2015 | Substantially Equivalent | Quidel Corporation |
| K141757 | ALERE I STREP A | Mar 31, 2015 | Substantially Equivalent | Alere Scarborough, Inc. |
| K143651 | Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack | Mar 18, 2015 | Substantially Equivalent | Focus Diagnostics, Inc. |
| K141338 | LIAT STREP A ASSAY | Nov 04, 2014 | Substantially Equivalent | Iquum, Inc. |
| K141173 | AMPLIVUE GAS ASSAY | Jul 24, 2014 | Substantially Equivalent | Quidel Corporation |
| DEN140005 | LYRA DIRECT STREP ASSAY | Apr 16, 2014 | Unknown | Quidel Corporation |
FEI Numbers
This FDA classification entry is associated with 17 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 17 registration numbers. Click on an entry to view related FDA registrations.