Cleared Traditional

illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control Kit, illumipro-10

K151046 · Meridian Bioscience, Inc. · Microbiology

Jul 2015

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K151046 is an FDA 510(k) clearance for the illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control Kit, illumipro-10, a Herpes Virus (vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples (Class II — Special Controls, product code PGI), submitted by Meridian Bioscience, Inc. (Cincinnati, US). The FDA issued a Cleared decision on July 17, 2015, 88 days after receiving the submission on April 20, 2015. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3309.

Submission Details

510(k) Number	K151046 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 20, 2015
Decision Date	July 17, 2015
Days to Decision	88 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	PGI — Herpes Virus (vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3309
Definition	For The Qualitative Detection And Differentiation Of Vzv, Hsv1, Hsv2- Dna In Cutaneous And Mucocutaneous Lesion Samples From Symptomatic Patients. The Assay Is Not Intended For Use With Cerebral Spinal Fluid.