Xpert Xpress Strep A

Q: What is the product code of K172126?

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) K172126 · Cepheid

Substantially Equivalent

510(k) numberK172126

Submission

Device name: Xpert Xpress Strep A
Applicant: Cepheid
Sunnyvale, CA, US
Received: July 14, 2017
Decision date: September 25, 2017
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
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
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
K261362	Xpert Hemorrhagic FeverQVR · Dual Track	08/07/2026SE
K261867	Xpert Carba-RPOC · Special	07/02/2026SE
K253653	Xpert Hemorrhagic Fever · Traditional	02/20/2026SE
K251721	Xpert GI PanelPCH · Traditional	01/16/2026SE
K250996	Xpert Xpress CoV-2/Flu/RSV plusQOF · Special	05/01/2025SE
K250995	Xpert Xpress CoV-2/Flu/RSV plusQOF · Special	05/01/2025SE
K243730	Xpert C. difficile/EpiOZN · Traditional	02/28/2025SE
K250218	Xpert® FII & FVNPR · Special	02/21/2025SE
K242109	Xpert® Xpress CoV-2 plus (XPRS-COV2-10)QQX · Dual Track	01/15/2025SE
K242071	Xpert Xpress CoV-2/Flu/RSV plusQOF · Dual Track	01/10/2025SE

Questions and answers

When was Xpert Xpress Strep A cleared by the FDA?

Xpert Xpress Strep A (K172126) received a 510(k) decision of Substantially Equivalent on September 25, 2017, 73 days after the submission was received.

What is the product code of K172126?

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.