Cleared Special

K221834 - Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
(FDA 510(k) Clearance)

K221834 · Centers For Disease Control and Prevention · Microbiology
Jun 2022
Decision
1d
Days
Class 2
Risk

K221834 is an FDA 510(k) clearance for the Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set. This device is classified as 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 June 24, 2022, 1 days after receiving the submission on June 23, 2022.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3315. In Vitro Qualitative Detection Of Non-variola Orthopoxvirus Nucleic Acids Extracted From Human Specimens Or Viral Culture..

Submission Details

510(k) Number K221834 FDA.gov
FDA Decision Cleared SESE
Date Received June 23, 2022
Decision Date June 24, 2022
Days to Decision 1 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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