FDA product code PBK: Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set
PBK is the FDA product code for non-variola orthopoxvirus real-time pcr primer and probe set. It is a Class II device, regulated under 21 CFR 866.3315 and reviewed by the Microbiology panel. FDA has cleared 4 510(k) submissions under PBK, 3 in the last five years. The average 510(k) review took 36 days (median 4). 1 De Novo request was granted under it.
Definition
In vitro qualitative detection of non-variola Orthopoxvirus nucleic acids extracted from human specimens or viral culture.
Classification
| Field | Value |
|---|---|
| Device name | Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set |
| Device class | Class II |
| Regulation | 21 CFR 866.3315 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for PBK
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 136 |
| 2022 | 3 | 3 |
Compare with all 510(k) review times · Search every PBK clearance
Top PBK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Centers for Disease Control and Prevention | 4 | 2022-08-30 |
Most recent PBK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K222558 | Centers for Disease Control and Prevention | Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set | 2022-08-30 | 6 |
| K221834 | Centers for Disease Control and Prevention | Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set | 2022-06-24 | 1 |
| K221658 | Centers for Disease Control and Prevention | Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set | 2022-06-10 | 2 |
| K181205 | Centers for Disease Control and Prevention | Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set | 2018-09-20 | 136 |
Recalls for PBK devices
openFDA lists no recalls for product code PBK.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- U0001 — Cdc 2019 novel coronavirus (2019-ncov) real-time rt-pcr diagnostic panel
Frequently asked questions
What is FDA product code PBK?
PBK is the FDA product code for non-variola orthopoxvirus real-time pcr primer and probe set. It is a Class II device, regulated under 21 CFR 866.3315 and reviewed by the Microbiology panel.
What device class is PBK?
Class II, regulation 21 CFR 866.3315. Typical premarket route: 510(k).
How long does a 510(k) take for product code PBK?
Across 4 cleared submissions the average was 36 days from receipt to decision (median 4).
Which companies have the most PBK clearances?
Centers for Disease Control and Prevention (4).
Next steps
- Run an FDA pathway report with predicate devices for product code PBK
- Run a recall and safety report across every PBK manufacturer
- Watch product code PBK for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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