Cleared Traditional

K191957 - BD MAX Vaginal Panel

K191957 is an FDA 510(k) clearance for BD MAX Vaginal Panel, manufactured by Geneohm Sciences Canada, Inc. (Bd Diagnostics). The device is a Class 2 Microbiology device with product code PQA cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K191957 · Geneohm Sciences Canada, Inc. (Bd Diagnostics) · Microbiology device
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Oct 2019
Decision
90d
Days
Class 2
Risk

K191957 is an FDA 510(k) clearance for the BD MAX Vaginal Panel. Classified as Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System (product code PQA), Class II - Special Controls.

Submitted by Geneohm Sciences Canada, Inc. (Bd Diagnostics) (Quebec, CA). The FDA issued a Cleared decision on October 21, 2019 after a review of 90 days - within the typical 510(k) review window.

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 Geneohm Sciences Canada, Inc. (Bd Diagnostics) devices

FDA 510(k) Submission Details - K191957

510(k) Number K191957 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2019
Decision Date October 21, 2019
Days to Decision 90 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
12d faster than avg
Panel avg: 102d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PQA Device Classification - Class 2, Special Controls

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 K191957.
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