Cleared Traditional

HSV 1 & 2 ELITe MGB Kit; ELITe InGenius

K180559 · Elitechgroup · Microbiology

Oct 2018

Decision

242d

Days

Class 2

Risk

About This 510(k) Submission

K180559 is an FDA 510(k) clearance for the HSV 1 & 2 ELITe MGB Kit; ELITe InGenius, a Herpes Virus (vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples (Class II — Special Controls, product code PGI), submitted by Elitechgroup (Bothell, US). The FDA issued a Cleared decision on October 29, 2018, 242 days after receiving the submission on March 1, 2018. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3309.

Submission Details

510(k) Number	K180559 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 01, 2018
Decision Date	October 29, 2018
Days to Decision	242 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.