Cleared Traditional

K190219 - Simplexa VZV Direct

K190219 is an FDA 510(k) clearance for Simplexa VZV Direct, manufactured by Diasorin Molecular, LLC. The device is a Class 2 Microbiology device with product code PLO cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K190219 · Diasorin Molecular, LLC · Microbiology device
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May 2019
Decision
98d
Days
Class 2
Risk

K190219 is an FDA 510(k) clearance for the Simplexa VZV Direct, Simplexa VZV Positive Control Pack. Classified as Meningitis/encephalitis Pathogen Multiplex Nucleic Acid Detection System (product code PLO), Class II - Special Controls.

Submitted by Diasorin Molecular, LLC (Cypress, US). The FDA issued a Cleared decision on May 13, 2019 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3970 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Diasorin Molecular, LLC devices

FDA 510(k) Submission Details - K190219

510(k) Number K190219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 102d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PLO Device Classification - Class 2, Special Controls

Product Code PLO Meningitis/encephalitis Pathogen Multiplex Nucleic Acid Detection System
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - PLO Meningitis/encephalitis Pathogen Multiplex Nucleic Acid Detection System

Devices cleared under the same product code (PLO) and FDA review panel - the closest regulatory comparables to K190219.
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