Centers for Disease Control and Prevention · Class II · Cleared Mar 30, 2026
| K-number | K260812 |
| Device name | Francisella tularensis Real-time PCR Assay |
| Applicant | Centers for Disease Control and Prevention |
| Product code | SGA |
| Device class | Class II |
| Decision date | Mar 30, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 866.4000 |
The Francisella tularensis Real-time PCR Assay is an in vitro diagnostic test that detects chromosomal DNA sequences from F. tularensis bacteria using real-time PCR technology. It is intended for qualitative detection in human whole blood (EDTA), pleural fluid, and bacterial culture isolates from individuals suspected of having tularemia, and use is limited to CDC-designated laboratories.
The technological characteristics remain identical to the predicate device (K252072). The assay consists of Ft Pan1 and Ft Pan2 primer and probe sets for universal F. tularensis detection, plus an RNase P control set and positive/negative controls. No technological characteristics were changed in this modification.
Not stated in this summary.
The modification was made only to update the Predetermined Change Control Plan (PCCP) for the FDA-cleared assay version 01, with no changes to technological characteristics, analytical limit of detection, or performance specifications. The submission supports substantial equivalence because the device remains functionally and technically identical to the predicate.
View the full FDA submission: accessdata.fda.gov