Cleared Traditional

K181205 - Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K181205 · Centers For Disease Control and Prevention · Microbiology device
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Sep 2018
Decision
136d
Days
Class 2
Risk

K181205 is an FDA 510(k) clearance 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 Cleared decision on September 20, 2018 after a review of 136 days - within the typical 510(k) review window.

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 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 Centers For Disease Control and Prevention devices

Submission Details

510(k) Number K181205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2018
Decision Date September 20, 2018
Days to Decision 136 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 102d · This submission: 136d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

Devices cleared under the same product code (PBK) and FDA review panel - the closest regulatory comparables to K181205.
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