Cleared Traditional

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 · Microbiology

Oct 2015

Decision

128d

Days

Class 2

Risk

About This 510(k) Submission

K151565 is an FDA 510(k) clearance for the 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, a Trichomonas Vaginalis Nucleic Acid Amplification Test System (Class II — Special Controls, product code OUY), submitted by Cepheid (Sunnyvale, US). The FDA issued a Cleared decision on October 16, 2015, 128 days after receiving the submission on June 10, 2015. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3860.

Submission Details

510(k) Number	K151565 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	OUY — Trichomonas Vaginalis Nucleic Acid Amplification Test System
Device Class	Class II — 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