PBK · Class II · 21 CFR 866.3315

FDA Product Code PBK: Non-variola Orthopoxvirus Real-time Pcr Primer And Probe Set

Monkeypox and related orthopoxvirus infections require rapid laboratory confirmation. FDA product code PBK covers non-variola orthopoxvirus real-time PCR assays.

These molecular tests detect and identify non-variola orthopoxvirus DNA — including monkeypox virus — from skin lesion specimens, vesicular fluid, and other samples. They are essential tools for outbreak response and infection control in mpox outbreaks.

PBK devices are Class II medical devices, regulated under 21 CFR 866.3315 and reviewed by the FDA Microbiology panel.

Leading manufacturers include Centers For Disease Control and Prevention.

5
Total
4
Cleared
882d
Avg days
2018
Since
Declining activity - 0 submissions in the last 2 years vs 3 in the prior period

FDA 510(k) Cleared Non-variola Orthopoxvirus Real-time Pcr Primer And Probe Set Devices (Product Code PBK)

5 devices
1–5 of 5
Cleared Aug 30, 2022
Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
K222558
Centers For Disease Control and Prevention
Microbiology · 6d
Cleared Jun 24, 2022
Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
K221834
Centers For Disease Control and Prevention
Microbiology · 1d
Cleared Jun 10, 2022
Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
K221658
Centers For Disease Control and Prevention
Microbiology · 2d

About Product Code PBK - Regulatory Context

510(k) Submission Activity

5 total 510(k) submissions under product code PBK since 2018, with 4 receiving FDA clearance (average review time: 882 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 3 in the prior period.

PBK devices are reviewed by the Microbiology panel. Browse all Microbiology devices →