FDA Product Code PGX: Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System
An In Vitro Diagnostic Test For The Detection Of Group A, C And G Beta Hemolytic Streptococcus In Throat Swab Specimens From Symptomatic Patients.
Leading manufacturers include Quidel Corporation, Alere Scarborough, Inc. and Cepheid.
15
Total
14
Cleared
127d
Avg days
2014
Since
Growing category -
2 submissions in the last 2 years
vs 0 in the prior period
Review times increasing: avg
183d
recently vs 119d historically
FDA 510(k) Cleared Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System Devices (Product Code PGX)
15 devices
Cleared
Aug 28, 2026
cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190)
Roche Molecular Systems, Inc.
Microbiology
233d
Cleared
Jun 15, 2026
LIAISON NES Group A Strep
Diasorin Molecular, LLC
Microbiology
133d
Cleared
Nov 09, 2020
Accula Strep A Test
Mesa Biotech, Inc.
Microbiology
181d
Cleared
Mar 06, 2019
GenePOC Strep A
Genepoc, Inc.
Microbiology
92d
Cleared
May 02, 2018
Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit
Alere Scarborough, Inc.
Microbiology
155d
Cleared
Apr 26, 2018
Xpert Xpress Strep A
Cepheid
Microbiology
177d
Cleared
Oct 30, 2017
ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit
Luminex Corporation
Microbiology
82d
Cleared
Sep 25, 2017
Xpert Xpress Strep A
Cepheid
Microbiology
73d
Cleared
Oct 25, 2016
Solana Strep Complete Assay
Quidel Corporation
Microbiology
74d
Cleared
Jun 23, 2015
Solana GAS Assay, Solana instrument
Quidel Corporation
Microbiology
83d
Cleared
Mar 31, 2015
ALERE I STREP A
Alere Scarborough, Inc.
Microbiology
274d
Cleared
Mar 18, 2015
Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack
Focus Diagnostics, Inc.
Microbiology
85d
Cleared
Nov 04, 2014
LIAT STREP A ASSAY
Iquum, Inc.
Microbiology
167d
Cleared
Jul 24, 2014
AMPLIVUE GAS ASSAY
Quidel Corporation
Microbiology
79d
Not Cleared
Apr 16, 2014
LYRA DIRECT STREP ASSAY
Quidel Corporation
Microbiology
22d
About Product Code PGX - Regulatory Context
510(k) Submission Activity
15 total 510(k) submissions under product code PGX since 2014, with 14 receiving FDA clearance (average review time: 127 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - PGX Product Code
Recent submissions under PGX have taken an average of 183 days to reach a decision - up from 119 days historically. Manufacturers should account for longer review timelines in current project planning.
PGX devices are reviewed by the Microbiology panel. Browse all Microbiology devices →