Cleared Special

K222558 - Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set (FDA 510(k) Clearance)

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

K222558 · Centers For Disease Control and Prevention · Microbiology device
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Aug 2022
Decision
6d
Days
Class 2
Risk

K222558 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 August 30, 2022 after a review of 6 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Centers For Disease Control and Prevention devices

Submission Details

510(k) Number K222558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2022
Decision Date August 30, 2022
Days to Decision 6 days
Submission Type Special
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
96d faster than avg
Panel avg: 102d · This submission: 6d
Pathway characteristics
Modification to existing cleared device.

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.