Cleared Traditional

K161182 - Solana Trichomonas Assay

K161182 is the FDA 510(k) clearance for Solana Trichomonas Assay by Quidel Corporation. It is a Class 2 Microbiology device (product code OUY) cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K161182 · Quidel Corporation · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2016
Decision
110d
Days
Class 2
Risk

K161182 is an FDA 510(k) clearance for the Solana Trichomonas Assay. Classified as Trichomonas Vaginalis Nucleic Acid Amplification Test System (product code OUY), Class II - Special Controls.

Submitted by Quidel Corporation (Athens, US). The FDA issued a Cleared decision on August 15, 2016 after a review of 110 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.

View all Quidel Corporation devices

Submission Details

510(k) Number K161182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2016
Decision Date August 15, 2016
Days to Decision 110 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
8d slower than avg
Panel avg: 102d · This submission: 110d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Microbiology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT02566447 Completed Observational Industry-sponsored

"Solana™ Trichomonas Assay Field Study"

750
Patients (actual)
4
Sites
Condition studied Trichomonas Vaginalis
Eligibility Female only
Sponsor Quidel Corporation (industry)
Started 2015-10-15 → Primary completion 2016-08-15
Primary outcome
Trichomonas Test Result
Study completed - no results published. This trial concluded in 2016 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

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 K161182.
BD MAX CTGCTV2, BD MAX System
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K151589 · Becton, Dickinson and Company · Sep 2016
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K161619 · Cepheid · 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
BD PROBETEC TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSAY
K130268 · Becton, Dickinson & CO · Aug 2013