Cleared Traditional

SEEGENE ANYPLEX II HSV-1/2 ASSAY

K142156 · Seegene · Microbiology

Feb 2015

Decision

191d

Days

Class 2

Risk

About This 510(k) Submission

K142156 is an FDA 510(k) clearance for the SEEGENE ANYPLEX II HSV-1/2 ASSAY, a Herpes Simplex Virus Nucleic Acid Amplification Assay (Class II — Special Controls, product code OQO), submitted by Seegene (Beverly, US). The FDA issued a Cleared decision on February 13, 2015, 191 days after receiving the submission on August 6, 2014. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3305.

Submission Details

510(k) Number	K142156 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 06, 2014
Decision Date	February 13, 2015
Days to Decision	191 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.