Cleared Traditional

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

K222638 · Cepheid · Microbiology

Sep 2023

Decision

391d

Days

Class 1

Risk

About This 510(k) Submission

K222638 is an FDA 510(k) clearance for the Xpert? Xpress GBS, GeneXpert? Dx System, GeneXpert? Infinity Systems, 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 September 27, 2023, 391 days after receiving the submission on September 1, 2022. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3740.

Submission Details

510(k) Number	K222638 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 01, 2022
Decision Date	September 27, 2023
Days to Decision	391 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.