GenePOC Strep A

Q: When was GenePOC Strep A cleared by the FDA?

GenePOC Strep A (K183366) received a 510(k) decision of Substantially Equivalent on March 6, 2019, 92 days after the submission was received.

Q: What is the product code of K183366?

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.

FDA 510(k) K183366 · Genepoc, Inc.

Substantially Equivalent

510(k) numberK183366

Submission

Device name: GenePOC Strep A
Applicant: Genepoc, Inc.
Quebec, CA
Received: December 4, 2018
Decision date: March 6, 2019
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

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

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
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

More from Alere Scarborough, Inc.

510(k)	Device	Decision
K190275	GenePOC CarbaPMY · Traditional	05/10/2019SE
K172569	GenePOC CDiffOZN · Traditional	11/22/2017SE
K170558	revogeneOOI · Traditional	05/25/2017SE
K170557	GenePOC GBS LBNJR · Traditional	05/25/2017SE

Questions and answers

When was GenePOC Strep A cleared by the FDA?

GenePOC Strep A (K183366) received a 510(k) decision of Substantially Equivalent on March 6, 2019, 92 days after the submission was received.

What is the product code of K183366?

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.