Cleared Special

K221160 - Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System (FDA 510(k) Clearance)

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

K221160 · Cepheid · Microbiology device
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Jun 2022
Decision
47d
Days
Class 2
Risk

K221160 is an FDA 510(k) clearance for the Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System. 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 June 7, 2022 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3975 - the FDA microbiology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Cepheid devices

Submission Details

510(k) Number K221160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2022
Decision Date June 07, 2022
Days to Decision 47 days
Submission Type Special
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
55d faster than avg
Panel avg: 102d · This submission: 47d
Pathway characteristics
Modification to existing cleared device.

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 10
Devices cleared under the same product code (PQA) and FDA review panel - the closest regulatory comparables to K221160.
BD Vaginal Panel
K243725 · Becton, Dickinson and Company · Dec 2024
Aptima BV Assay
K243345 · Hologic, Inc. · Nov 2024
Xpert Xpress MVP
K231381 · Cepheid · Oct 2023
BD Vaginal Panel
K223653 · Becton, Dickinson and Company · Mar 2023
Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System
K212213 · Cepheid · Feb 2022