Cleared Traditional

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

K203429 · Cepheid · Microbiology

May 2022

Decision

535d

Days

Class 1

Risk

About This 510(k) Submission

K203429 is an FDA 510(k) clearance for the Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System, a Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test (Class I — General Controls, product code NJR), submitted by Cepheid (Sunnyvale, US). The FDA issued a Cleared decision on May 9, 2022, 535 days after receiving the submission on November 20, 2020. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3740.

Submission Details

510(k) Number	K203429 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 20, 2020
Decision Date	May 09, 2022
Days to Decision	535 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	NJR — Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Device Class	Class I — General Controls
CFR Regulation	21 CFR 866.3740
Definition	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.