Cleared Traditional

Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack

K192376 · Diasorin Molecular, LLC · Microbiology

Nov 2019

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K192376 is an FDA 510(k) clearance for the Simplexa VZV Swab Direct, Simplexa VZV 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 November 26, 2019, 88 days after receiving the submission on August 30, 2019. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3309.

Submission Details

510(k) Number	K192376 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 30, 2019
Decision Date	November 26, 2019
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.