Cleared Traditional

K222638 - Xpert Xpress GBS

K222638 is an FDA 510(k) clearance for Xpert Xpress GBS, manufactured by Cepheid. The device is a Class 1 Microbiology device with product code NJR cleared through the Traditional 510(k) pathway after a 391-day FDA review.

K222638 · Cepheid · Microbiology device
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Sep 2023
Decision
391d
Days
Class 1
Risk

K222638 is an FDA 510(k) clearance for the Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems. Classified as Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test (product code NJR), Class I - General Controls.

Submitted by Cepheid (Sunnyvale, US). The FDA issued a Cleared decision on September 27, 2023 after a review of 391 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3740 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Cepheid devices

FDA 510(k) Submission Details - K222638

510(k) Number K222638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
289d slower than avg
Panel avg: 102d · This submission: 391d
Pathway characteristics
Predicate-based equivalence.

NJR Device Classification - Class 1, General Controls

Product Code NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Device Class Class 1 - 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.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test

All 12
Devices cleared under the same product code (NJR) and FDA review panel - the closest regulatory comparables to K222638.
Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System
K203429 · Cepheid · May 2022
Simplexa GBS Direct, Simplexa GBS Positive Control Pack
K182467 · Diasorin Molecular, LLC · Nov 2018
Panther Fusion GBS Assay
K181156 · Diagenode · Jul 2018
NeuMoDx GBS Assay
K173725 · Neumodx Molecular, Inc. · Jun 2018
Solana GBS Assay
K173250 · Quidel Corporation · Dec 2017
AMPLIVUE GBS ASSAY
K133503 · Quidel Corporation · Dec 2013