Cleared Traditional

ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD), ARIES HSV 1&2 Assay Cassette (IVD)

K151906 · Luminex Corporation · Microbiology

Oct 2015

Decision

85d

Days

Class 2

Risk

About This 510(k) Submission

K151906 is an FDA 510(k) clearance for the ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD), ARIES HSV 1&2 Assay Cassette (IVD), a Herpes Virus (vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples (Class II — Special Controls, product code PGI), submitted by Luminex Corporation (Austin, US). The FDA issued a Cleared decision on October 6, 2015, 85 days after receiving the submission on July 13, 2015. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3309.

Submission Details

510(k) Number	K151906 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 13, 2015
Decision Date	October 06, 2015
Days to Decision	85 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.