# K181205: Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set

- Pathway: 510(k) (Traditional)
- Applicant: Centers for Disease Control and Prevention
- Decided: Sep 20, 2018 after 136 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: 1 generation back to DEN060008 (2006). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN060008: Influenza a/H5 (Asian Lineage) Virus Real-Time RT-PCR Primer and Probe Set, Centers for Disease Control and Prevention (2006). Our reading of the summary gave K053469, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN060008, Influenza a/H5 (Asian Lineage) Virus Real-Time RT-PCR… (Centers for Disease Control and Prevention), granted Feb 3, 2006; older De Novo requests were first filed under a 510(k) number, so this links to the grant.

## Most influential descendants
- K221658: Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set (2022), 2 descendants of its own
- K221834: Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set (2022), 1 descendant of its own
- K222558: Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set (2022), 0 descendants of its own

## 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 Laboratory Response Network (LRN) reference 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 presumptive 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 Laboratory Response Network (LRN) designated laboratories.

Source page: https://510kreport.com/device/K181205
Methodology: https://510kreport.com/methodology