# K222558: Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set

- Pathway: 510(k) (Special)
- Applicant: Centers for Disease Control and Prevention
- Decided: Aug 30, 2022 after 6 days
- Product code: PBK (Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set)
- Device class: 2
- Regulation: 21 CFR 866.3315
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to DEN060008 (2006). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221834: Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set, Centers for Disease Control and Prevention (2022) Summary page 4.

## Indications for use
The Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set is intended for the in vitro qualitative presumptive detection of non-variola Orthopoxvirus DNA extracted from human pustular or vesicular rash specimens and viral cell culture lysates submitted to a Centers for Disease Control and Prevention designated laboratory. The assay detects non- variola Orthopoxvirus DNA, including vaccinia, cowpox, monkeypox and ectromelia viruses at varying concentrations. This assay does not differentiate vaccinia virus or monkeypox virus from other orthopoxviruses detected by this assay and does not detect variola virus. Refer to the CDC algorithm, Acute, Generalized Vesicular or Pustular Rash Illness Testing Protocol in the United States for recommended testing and evaluation algorithms for patients presenting with acute, generalized pustular or vesicular rash illness. Results of this assay are for the identification of non-variola Orthopoxvirus DNA. These results must be used in conjunction with other diagnostic assays and clinical observations to diagnose Orthopoxvirus infection. The assay should only be used to test specimens with low/moderate risk of smallpox. If a high risk of smallpox exists, viral culture should not be attempted. Negative results obtained with this device do not preclude Variola virus infection and should not be used as the sole basis for treatment or other patient management decisions. Use is limited to Centers for Disease Control and Prevention designated laboratories.

Source page: https://510kreport.com/device/K222558
Methodology: https://510kreport.com/methodology