Cleared Traditional

Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48, Genxpert Infinity-48s and GeneXpert Infinity-80 Systems

K161619 · Cepheid · Microbiology

Aug 2016

Decision

77d

Days

Class 2

Risk

About This 510(k) Submission

K161619 is an FDA 510(k) clearance for the Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48, Genxpert Infinity-48s and GeneXpert Infinity-80 Systems, 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 August 29, 2016, 77 days after receiving the submission on June 13, 2016. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3860.

Submission Details

510(k) Number	K161619 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 13, 2016
Decision Date	August 29, 2016
Days to Decision	77 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