Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems

Q: What is the product code of K222638?

The FDA product code is NJR – Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test, a Class I (low risk) device regulated under 21 CFR 866.3740.

FDA 510(k) K222638 · Cepheid

Substantially Equivalent

510(k) numberK222638

Submission

Device name: Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems
Applicant: Cepheid
Sunnyvale, CA, US
Received: September 1, 2022
Decision date: September 27, 2023
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: NJR – Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Device class: Class I (low risk)
Regulation: 21 CFR 866.3740
Specialty: Microbiology

A nucleic acid amplification assay system (including probes, other reagents, and instrumentation) is an aid in the identification of group b streptococci from pre-partum and intra-partum women to establish colonization status.

Other 510(k)s with product code NJR

510(k)	Device	Applicant	Decision
K203429	Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity SystemNJR · Traditional	Cepheid	05/09/2022SE
K182467	Simplexa GBS Direct, Simplexa GBS Positive Control PackNJR · Traditional	Diasorin Molecular, LLC	11/07/2018SE
K181156	Panther Fusion GBS AssayNJR · Traditional	Diagenode	07/27/2018SE
K173725	NeuMoDx GBS AssayNJR · Traditional	Neumodx Molecular, Inc.	06/26/2018SE
K173250	Solana GBS AssayNJR · Traditional	Quidel Corporation	12/21/2017SE
K170557	GenePOC GBS LBNJR · Traditional	Genepoc, Inc.	05/25/2017SE
K162772	ARIES GBS AssayNJR · Traditional	Luminex Corporation	12/23/2016SE
K143312	Portrait GBS AssayNJR · Traditional	Great Basin Corporation	04/21/2015SE
K133503	Amplivue GBS AssayNJR · Traditional	Quidel Corporation	12/20/2013SE
K121539	Xpert GBS LB Genexpert DX Systems (Gx-I, Gx-Iv) Genexpert DX Systems (Gx-Xvi) Genexpert…NJR · Traditional	Cepheid	11/02/2012SE

More from Cepheid

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 GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems cleared by the FDA?

Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems (K222638) received a 510(k) decision of Substantially Equivalent on September 27, 2023, 391 days after the submission was received.

What is the product code of K222638?

The FDA product code is NJR – Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test, a Class I (low risk) device regulated under 21 CFR 866.3740.