Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System

Q: What is the product code of K203429?

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) K203429 · Cepheid

Substantially Equivalent

510(k) numberK203429

Submission

Device name: Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System
Applicant: Cepheid
Sunnyvale, CA, US
Received: November 20, 2020
Decision date: May 9, 2022
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
K222638	Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity SystemsNJR · Traditional	Cepheid	09/27/2023SE
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 GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System cleared by the FDA?

Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System (K203429) received a 510(k) decision of Substantially Equivalent on May 9, 2022, 535 days after the submission was received.

What is the product code of K203429?

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.