510(k) · Cleared
ClearedFrancisella tularensis Real-time PCR Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Centers for Disease Control and Prevention · SGA Biothreat Microbial Agent Nucleic Acid Detection Test
Cleared on Mar 30, 2026 as substantially equivalent to K252072 (Centers for Disease Control and Prevention, 2025) after a 17-day review. Its family tree reaches back 2 generations to 2017.
- Decided
- Mar 30, 2026
- Review
- 17 days
- Class
- Class II
- Product code
- SGA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K170883 (2017). No later device cites it as a predicate yet.
- Root · 2 generations backK170883 FilmArray NGDS Warrior PanelBiofire Defense, LLC · 2017 · Recalled
- 1 generation backK252072 Francisella tularensis Real-time PCR assayCenters for Disease Control and Prevention · 2025
- This deviceK260812 Francisella tularensis Real-time PCR AssayCenters for Disease Control and Prevention · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K170883 | FilmArray NGDS Warrior Panel | Biofire Defense, LLC | 2017 | 3 |
| −1 | K252072 | Francisella tularensis Real-time PCR assay | Centers for Disease Control and Prevention | 2025 | — |
| 0 (this device) | K260812 | Francisella tularensis Real-time PCR Assay | Centers for Disease Control and Prevention | 2026 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in SGA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new SGA device
- #1 K252072 Francisella tularensis Real-time PCR assayscore 13.1 · 1 generation · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K252072 | Francisella tularensis Real-time PCR assaySummary page 5…Detection System For Biothreat Agents Product Code: SGA Predicate device(s): Francisella tularensis Real-time PCR assay (K252072) Page 1 of 3 Centers for D… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 8.3 years on median.
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All SGA devicesSGA Biothreat Microbial Agent Nucleic Acid Detection Test: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · SGA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · SGA
Too few SGA 510(k)s in any year since 2007 to give a median.
Recalls per year · SGA
No recall names SGA since 2007.
Adverse event reports per year · SGA
No MAUDE report names SGA since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (160 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260812 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260812: Francisella tularensis Real-time PCR Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260812
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026