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, Cepheid and Alere Scarborough, Inc..
14
Total
13
Cleared
120d
Avg days
2014
Since
Growing category -
1 submissions in the last 2 years
vs 0 in the prior period
Consistent review times:
133d avg (recent)
FDA 510(k) Cleared Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System Devices (Product Code PGX)
14 devices
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
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
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
14 total 510(k) submissions under product code PGX since 2014, with 13 receiving FDA clearance (average review time: 120 days).
Submission volume has increased in recent years - 1 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
FDA review times for PGX submissions have been consistent, averaging 133 days recently vs 119 days historically.
PGX devices are reviewed by the Microbiology panel. Browse all Microbiology devices →