Cleared Dual Track

Xpert Xpress MVP (K231381) - FDA 510(k) Clearance

Also marketed or referenced as:
GeneXpert Xpress System

Class II Microbiology device cleared through the Dual Track 510(k) pathway - typically does not require clinical trials.

K231381 · Cepheid · Microbiology device
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Oct 2023
Decision
160d
Days
Class 2
Risk

K231381 is an FDA 510(k) clearance for the Xpert Xpress MVP. Classified as Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System (product code PQA), Class II - Special Controls.

Submitted by Cepheid (Sunnyvale, US). The FDA issued a Cleared decision on October 19, 2023 after a review of 160 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3975 - 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. Standard predicate reliance. 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

Submission Details

510(k) Number K231381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2023
Decision Date October 19, 2023
Days to Decision 160 days
Submission Type Dual Track
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
58d slower than avg
Panel avg: 102d · This submission: 160d
Pathway characteristics

Device Classification

Product Code PQA Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3975
Definition A Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System Is A Qualitative In Vitro Diagnostic Device For The Direct Detection Of Nucleic Acid Sequences From Microorganisms Associated With Vaginitis Or Bacterial Vaginosis. The Device Is Indicated For Individuals With Signs And Symptoms Of Vaginitis Or Bacterial Vaginosis And Aids In The Diagnosis Of These Vaginal Infections.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - PQA Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System

All 9
Devices cleared under the same product code (PQA) and FDA review panel - the closest regulatory comparables to K231381.
BD Vaginal Panel
K243725 · Becton, Dickinson and Company · Dec 2024
Aptima BV Assay
K243345 · Hologic, Inc. · Nov 2024
BD Vaginal Panel
K223653 · Becton, Dickinson and Company · Mar 2023
Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System
K221160 · Cepheid · Jun 2022
Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System
K212213 · Cepheid · Feb 2022
BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit
K201017 · Geneohm Sciences Canada, Inc. (Bd Life Sciences) · Oct 2021