Cleared Traditional

K201017 - BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit (FDA 510(k) Clearance)

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

K201017 · Geneohm Sciences Canada, Inc. (Bd Life Sciences) · Microbiology device
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Oct 2021
Decision
549d
Days
Class 2
Risk

K201017 is an FDA 510(k) clearance for the BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit. Classified as Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System (product code PQA), Class II - Special Controls.

Submitted by Geneohm Sciences Canada, Inc. (Bd Life Sciences) (Quebec, CA). The FDA issued a Cleared decision on October 18, 2021 after a review of 549 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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 Geneohm Sciences Canada, Inc. (Bd Life Sciences) devices

Submission Details

510(k) Number K201017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2020
Decision Date October 18, 2021
Days to Decision 549 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
447d slower than avg
Panel avg: 102d · This submission: 549d
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 K201017.
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
Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System
K212213 · Cepheid · Feb 2022