Cleared Traditional

K212213 - Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K212213 · Cepheid · Microbiology device
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Feb 2022
Decision
209d
Days
Class 2
Risk

K212213 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 February 9, 2022 after a review of 209 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 K212213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2021
Decision Date February 09, 2022
Days to Decision 209 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
107d slower than avg
Panel avg: 102d · This submission: 209d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K212213.
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
K221160 · Cepheid · Jun 2022