Cleared Traditional

Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems, GeneXpert Infinity-48 System, Xpert Vaginal/Endocervical Specimen Collection, Xpert Urine Specimen Collection Kit, Xpert Swab Specimen Collection Kit

K190441 · Cepheid · Microbiology

May 2019

Decision

87d

Days

Class 2

Risk

About This 510(k) Submission

K190441 is an FDA 510(k) clearance for the Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems, GeneXpert Infinity-48 System, Xpert Vaginal/Endocervical Specimen Collection, Xpert Urine Specimen Collection Kit, Xpert Swab Specimen Collection Kit, a Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections (Class II — Special Controls, product code QEP), submitted by Cepheid (Sunnyvale, US). The FDA issued a Cleared decision on May 23, 2019, 87 days after receiving the submission on February 25, 2019. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3393.

Submission Details

510(k) Number	K190441 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 25, 2019
Decision Date	May 23, 2019
Days to Decision	87 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	QEP — Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3393
Definition	A Device To Detect Nucleic Acids From Non-viral Microorganism(s) Causing Sexually Transmitted Infections Is An In Vitro Diagnostic Device Intended For The Detection And Identification Of Nucleic Acids From Non-viral Microorganism(s) In Clinical Specimens Collected From Patients Suspected Of Sexually Transmitted Infections. The Device Is Intended To Aid In The Diagnosis Of Non-viral Sexually Transmitted Infections In Conjunction With Other Clinical And Laboratory Data.