Cleared Special

Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set

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

About This 510(k) Submission

K222558 is an FDA 510(k) clearance for the Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set, a Non-variola Orthopoxvirus Real-time Pcr Primer And Probe Set (Class II — Special Controls, product code PBK), submitted by Centers For Disease Control and Prevention (Atlanta, US). The FDA issued a Cleared decision on August 30, 2022, 6 days after receiving the submission on August 24, 2022. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3315.

Submission Details

510(k) Number K222558 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code PBK — Non-variola Orthopoxvirus Real-time Pcr Primer And Probe Set
Device Class Class II — 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.

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