Not Cleared Post-NSE

DEN110012 - APTIMA TRICHOMONAS VAGINALIS ASSAY

DEN110012 is an FDA 510(k) submission for APTIMA TRICHOMONAS VAGINALIS ASSAY, manufactured by Gen-Probe Incorporated. The device is a Class 2 Microbiology device with product code OUY cleared through the Post-NSE 510(k) pathway after a 6-day FDA review.

DEN110012 · Gen-Probe Incorporated · Microbiology device
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Apr 2011
Decision
6d
Days
Class 2
Risk

DEN110012 is an FDA 510(k) submission (not cleared) for the APTIMA TRICHOMONAS VAGINALIS ASSAY. Classified as Trichomonas Vaginalis Nucleic Acid Amplification Test System (product code OUY), Class II - Special Controls.

Submitted by Gen-Probe Incorporated (San Diego, US). The FDA issued a Not Cleared (DENG) decision on April 19, 2011 after a review of 6 days.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3860 - the FDA microbiology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Microbiology review framework.

FDA 510(k) Submission Details - DEN110012

510(k) Number DEN110012 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received April 13, 2011
Decision Date April 19, 2011
Days to Decision 6 days
Submission Type Post-NSE
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 102d · This submission: 6d
Pathway characteristics

OUY Device Classification - Class 2, Special Controls

Product Code OUY Trichomonas Vaginalis Nucleic Acid Amplification Test System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3860
Definition In Vitro Nucleic Acid Amplification Test For The Qualitative Detection Of Ribosomal Rna From Trichomonas Vaginalis As An Aid In The Diagnosis Of Trichomoniasis From Vaginal, Cervical, Urogenital And Gynecological Specimens From Symptomatic Patients
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.

DEN110012 · APTIMA TRICHOMONAS VAGINALIS ASSAY
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