Cleared Traditional

artus HSV-1/2 QS-RGQ MDx Kit

K142738 · Qiagen · Microbiology

Dec 2014

Decision

87d

Days

Class 2

Risk

About This 510(k) Submission

K142738 is an FDA 510(k) clearance for the artus HSV-1/2 QS-RGQ MDx Kit, a Herpes Simplex Virus Nucleic Acid Amplification Assay (Class II — Special Controls, product code OQO), submitted by Qiagen (Gernmantown, US). The FDA issued a Cleared decision on December 19, 2014, 87 days after receiving the submission on September 23, 2014. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3305.

Submission Details

510(k) Number	K142738 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 23, 2014
Decision Date	December 19, 2014
Days to Decision	87 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	OQO — Herpes Simplex Virus Nucleic Acid Amplification Assay
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3305
Definition	A Polymerase Chain Reaction (pcr)-based Qualitative In Vitro Diagnostic Test For The Detection And Typing Of Herpes Simplex Virus (hsv) Dna Using Vaginal Swab Specimens.