Cleared Traditional

Simplexa VZV Direct, Simplexa VZV Positive Control Pack

K190219 · Diasorin Molecular, LLC · Microbiology

May 2019

Decision

98d

Days

Class 2

Risk

About This 510(k) Submission

K190219 is an FDA 510(k) clearance for the Simplexa VZV Direct, Simplexa VZV Positive Control Pack, a Meningitis/encephalitis Pathogen Multiplex Nucleic Acid Detection System (Class II — Special Controls, product code PLO), submitted by Diasorin Molecular, LLC (Cypress, US). The FDA issued a Cleared decision on May 13, 2019, 98 days after receiving the submission on February 4, 2019. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3970.

Submission Details

510(k) Number	K190219 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 04, 2019
Decision Date	May 13, 2019
Days to Decision	98 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	PLO — Meningitis/encephalitis Pathogen Multiplex Nucleic Acid Detection System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3970
Definition	A Meningitis/encephalitis Pathogen Multiplex Nucleic Acid Detection System Is A Qualitative In Vitro Diagnostic Test For The Direct Detection And Identification Of Microbial-associated Nucleic Acids In Cerebrospinal Fluid. The Test Is Indicated For Individuals With Signs And Symptoms Of Meningitis Or Encephalitis And Aids In Diagnosis Of Agents Of Meningitis Or Encephalitis When Used In Conjunction With Clinical And Other Laboratory Findings.