Cleared Traditional

K151565 - 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 (FDA 510(k) Clearance)

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

K151565 · Cepheid · Microbiology device
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Oct 2015
Decision
128d
Days
Class 2
Risk

K151565 is an FDA 510(k) clearance for the Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, Ge.... Classified as Trichomonas Vaginalis Nucleic Acid Amplification Test System (product code OUY), Class II - Special Controls.

Submitted by Cepheid (Sunnyvale, US). The FDA issued a Cleared decision on October 16, 2015 after a review of 128 days - within the typical 510(k) review window.

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.

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Submission Details

510(k) Number K151565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2015
Decision Date October 16, 2015
Days to Decision 128 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 102d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.