Cleared Traditional

K221658 - 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.

K221658 · Centers For Disease Control and Prevention · Microbiology device
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Jun 2022
Decision
2d
Days
Class 2
Risk

K221658 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 June 10, 2022 after a review of 2 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Centers For Disease Control and Prevention devices

Submission Details

510(k) Number K221658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2022
Decision Date June 10, 2022
Days to Decision 2 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
100d faster than avg
Panel avg: 102d · This submission: 2d
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.