Cleared Traditional

Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack

K173798 · Diasorin Molecular, LLC · Microbiology

Mar 2018

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K173798 is an FDA 510(k) clearance for the Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack, a Herpes Virus (vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples (Class II — Special Controls, product code PGI), submitted by Diasorin Molecular, LLC (Cypress, US). The FDA issued a Cleared decision on March 14, 2018, 90 days after receiving the submission on December 14, 2017. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3309.

Submission Details

510(k) Number	K173798 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 14, 2017
Decision Date	March 14, 2018
Days to Decision	90 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.