Cleared Traditional

K203429 - Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System (FDA 510(k) Clearance)

Class I Microbiology device.

K203429 · Cepheid · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2022
Decision
535d
Days
Class 1
Risk

K203429 is an FDA 510(k) clearance for the Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System. 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 May 9, 2022 after a review of 535 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

View all Cepheid devices

Submission Details

510(k) Number K203429 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
433d slower than avg
Panel avg: 102d · This submission: 535d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.