Home / 510(k) Clearances / K221834

510(k) K221834

Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set by Centers for Disease Control and Prevention — Product Code PBK

K221834 is an FDA 510(k) premarket notification submitted by Centers for Disease Control and Prevention for the device "Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set". The FDA issued a decision of Substantially Equivalent on June 24, 2022. The device falls under product code PBK (Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set), a Class II device regulated under 21 CFR 866.3315. Centers for Disease Control and Prevention has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 2022
Date Received
June 23, 2022
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set
Device Class
Class II
Regulation Number
866.3315
Review Panel
MI
Submission Type

In vitro qualitative detection of non-variola Orthopoxvirus nucleic acids extracted from human specimens or viral culture.

Other clearances by Centers for Disease Control and Prevention

  • K260812 — Francisella tularensis Real-time PCR Assay (March 30, 2026)
  • K252072 — Francisella tularensis Real-time PCR assay (September 30, 2025)
  • K243274 — CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typin (July 11, 2025)
  • K243931 — CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typin (March 14, 2025)
  • K241110 — CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtypi (May 21, 2024)
  • K222558 — Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set (August 30, 2022)
  • K221658 — Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set (June 10, 2022)
  • K200370 — CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typin (March 10, 2020)
  • K192871 — B. anthracis Real-time PCR Assay (November 7, 2019)
  • K190302 — CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typin (March 27, 2019)

Other clearances for product code PBK

  • K222558 — Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set (August 30, 2022)
  • K221658 — Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set (June 10, 2022)
  • DEN070001 — NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET (September 21, 2018)
  • K181205 — Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set (September 20, 2018)

FDA data resources