Not Cleared Direct

DEN160016 - Variola virus Real-Time PCR Assay (FDA 510(k) Clearance)

Class II Microbiology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN160016 · Centers For Disease Control and Prevention (Cdc) · Microbiology device
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Feb 2017
Decision
298d
Days
Class 2
Risk

DEN160016 is an FDA 510(k) submission (not cleared) for the Variola virus Real-Time PCR Assay. Classified as Variola Virus Nucleic Acid-based Detection Assay (product code PRA), Class II - Special Controls.

Submitted by Centers For Disease Control and Prevention (Cdc) (Atlanta, US). The FDA issued a Not Cleared (DENG) decision on February 6, 2017 after a review of 298 days.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3316 - the FDA microbiology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. Elevated predicate reliance profile. With 298 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Centers For Disease Control and Prevention (Cdc) devices

Submission Details

510(k) Number DEN160016 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received April 14, 2016
Decision Date February 06, 2017
Days to Decision 298 days
Submission Type Direct
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
196d slower than avg
Panel avg: 102d · This submission: 298d
Pathway characteristics

Device Classification

Product Code PRA Variola Virus Nucleic Acid-based Detection Assay
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3316
Definition The Variola Virus Nucleic Acid-based Detection Assay Is Intended For Individuals Presenting With Pustular Or Vesicular Rash Illness Or Other Signs And Symptoms Of Variola Virus Infection. The Test Results Must Be Used In Conjunction With Other Diagnostic Assays And Clinical Observations, As An Aid To The Diagnosis Of Infection, In Accordance With The Criteria Defined By The Appropriate Public Health Authorities With The Federal Government.
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.