Cleared Traditional

K130268 - BD PROBETEC TRICHOMONAS VAGINALIS (TV) ...

K130268 is an FDA 510(k) clearance for BD PROBETEC TRICHOMONAS VAGINALIS (TV) ..., manufactured by Becton, Dickinson & CO. The device is a Class 2 Microbiology device with product code OUY cleared through the Traditional 510(k) pathway after a 200-day FDA review.

K130268 · Becton, Dickinson & CO · Microbiology device
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Aug 2013
Decision
200d
Days
Class 2
Risk

K130268 is an FDA 510(k) clearance for the BD PROBETEC TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSAY. Classified as Trichomonas Vaginalis Nucleic Acid Amplification Test System (product code OUY), Class II - Special Controls.

Submitted by Becton, Dickinson & CO (Sparks, US). The FDA issued a Cleared decision on August 23, 2013 after a review of 200 days - an extended review cycle.

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 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 Becton, Dickinson & CO devices

FDA 510(k) Submission Details - K130268

510(k) Number K130268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2013
Decision Date August 23, 2013
Days to Decision 200 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
98d slower than avg
Panel avg: 102d · This submission: 200d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.

Regulatory Peers - OUY Trichomonas Vaginalis Nucleic Acid Amplification Test System

All 8
Devices cleared under the same product code (OUY) and FDA review panel - the closest regulatory comparables to K130268.
Solana Trichomonas Assay
K161182 · Quidel Corporation · Aug 2016
Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpertInfinity-80 systems), Xpert Vaginal/Endocervical Specimen Collection Kit, and Xpert Urine Specimen Collection Kit
K151565 · Cepheid · Oct 2015
AmpliVue Trichomonas Assay
K143329 · Quidel Corporation · Mar 2015
APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER
K122062 · Gen-Probe, Inc. · Jan 2013