# K260812: Francisella tularensis Real-time PCR Assay

- Pathway: 510(k) (Special)
- Applicant: Centers for Disease Control and Prevention
- Decided: Mar 30, 2026 after 17 days
- Product code: SGA (Biothreat Microbial Agent Nucleic Acid Detection Test)
- Device class: 2
- Regulation: 21 CFR 866.4000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K170883 (2017). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K252072: Francisella tularensis Real-time PCR assay, Centers for Disease Control and Prevention (2025) Summary page 5.

## Indications for use
The Francisella tularensis Real-time PCR Assay is an in vitro diagnostic test for the qualitative detection of chromosomal DNA sequences from F. tularensis. The assay can be used to test human whole blood EDTA, pleural fluid, and bacterial culture isolates grown on agar from individuals suspected of having tularemia. Results generated from direct specimen testing are presumptive for the identification of F. tularensis. Results generated from culture isolate testing are used as part of the LRN Francisella tularensis Testing Algorithm. The diagnosis of F. tularensis infection must be made based on history, signs, symptoms, exposure likelihood, and other laboratory evidence, in addition to the identification of F. tularensis from culture isolates or from clinical specimens. Negative results do not preclude infection with the biothreat microbial agents targeted by the device and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Use is limited to Centers for Disease Control and Prevention (CDC) designated laboratories.

Source page: https://510kreport.com/device/K260812
Methodology: https://510kreport.com/methodology