Not Cleared Post-NSE

DEN070001 - NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET (FDA 510(k) Clearance)

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

DEN070001 · Centers For Disease Control and Prevention · Microbiology device
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Sep 2018
Decision
4266d
Days
Class 2
Risk

DEN070001 is an FDA 510(k) submission (not cleared) for the NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET. Classified as Non-variola Orthopoxvirus Real-time Pcr Primer And Probe Set (product code PBK), Class II - Special Controls.

Submitted by Centers For Disease Control and Prevention (Atlanta, US). The FDA issued a Not Cleared (DENG) decision on September 21, 2018 after a review of 4266 days.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3315 - 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. High predicate equivalence gap. With 4266 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 devices

Submission Details

510(k) Number DEN070001 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received January 16, 2007
Decision Date September 21, 2018
Days to Decision 4266 days
Submission Type Post-NSE
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4164d slower than avg
Panel avg: 102d · This submission: 4266d
Pathway characteristics

Device Classification

Product Code PBK Non-variola Orthopoxvirus Real-time Pcr Primer And Probe Set
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3315
Definition In Vitro Qualitative Detection Of Non-variola Orthopoxvirus Nucleic Acids Extracted From Human Specimens Or Viral Culture.
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 - PBK Non-variola Orthopoxvirus Real-time Pcr Primer And Probe Set

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