510(k) · Cleared
ClearedJbaids Tularemia Detection Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biofire Diagnostics, Inc. · OEH Joint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection Kit
Cleared on Jul 31, 2013 as substantially equivalent to K072547 (Idaho Technology, Inc., 2007) after a 34-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Jul 31, 2013
- Review
- 34 days
- Class
- Class II
- Product code
- OEH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K952138 (1995). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K952138 | Sas Francisella Tularensis Antigen | Sa Scientific, Inc. | 1995 | — |
| −1 | K072547 | Jbaids Tularemia Detection Kit, Model JRPD-Asy-0124 | Idaho Technology, Inc. | 2007 | — |
| 0 (this device) | K131936 | Jbaids Tularemia Detection Kit | Biofire Diagnostics, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
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 OEH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | K072547 | Jbaids Tularemia Detection Kit, Model JRPD-Asy-0124Summary page 1…umber: 21 CER 866.3280 Classification Name: Reagent Kit: F. tlarcuisis,Class 11 Product Code: OEH Predicate Device: JBAIDS Tularemia Detection Kit (K072547) Intended Use: The Joint Biological Agent Identification and Diagnostic System (JBAIDS) Tularemia Detection Kit is… | 2007 |
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 18 years and passes through 3 companies; a new generation was cleared every 12.4 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All OEH devicesOEH Joint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection Kit: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · OEH
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · OEH
Too few OEH 510(k)s in any year since 2007 to give a median.
Recalls per year · OEH
No recall names OEH since 2007.
Adverse event reports per year · OEH
No MAUDE report names OEH since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 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 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Joint Biological Agent Identification and Diagnostic System (JBAIDS) Tularemia Detection Kit is a real-time polymerase chain reaction (PCR) test kit intended for the qualitative in vitro diagnostic (IVD) detection of target DNA sequences of Francisella tularensis. The system can be used to test human whole blood collected in sodium citrate or sputum collected aseptically from individuals greater than 18 years of age suspected of having tularemia. In…
Read the full statement (308 words)
The Joint Biological Agent Identification and Diagnostic System (JBAIDS) Tularemia Detection Kit is a real-time polymerase chain reaction (PCR) test kit intended for the qualitative in vitro diagnostic (IVD) detection of target DNA sequences of Francisella tularensis. The system can be used to test human whole blood collected in sodium citrate or sputum collected aseptically from individuals greater than 18 years of age suspected of having tularemia. In addition, positive blood cultures and colonies may be tested. This assay is intended to aid in the diagnosis of individual presenting with signs and symptoms of pneumonic or typhoidal tularemia. It is not intended to aid in the diagnosis of glandular, ulceroglandular, oculoglandular, or oropharyngeal tularemia.
The JBAIDS Tularemia Detection Kit is run on the JBAIDS instrument using the Diagnostic Wizard. Results are for the presumptive identification of F. tularensis in conjunction with culture and other laboratory tests. The definitive identification of F. tularensis from colony growth, liquid blood culture growth, blood specimens, or sputum specimens requires additional testing and confirmation procedures in consultation with public health or other authorities for whom reports are required.
The diagnosis of tularemia must be made based on history, signs, symptoms, exposure likelihood, and other laboratory evidence in addition to the identification of the target either from colonies, blood culture, whole blood or sputum specimens.
The JBAIDS Tularemia Detection Kit is intended for use by trained clinical laboratory personnel who have received specific training on the use of the JBAIDS Tularemia Detection Kit. The level of F. tularensis that would be present in blood or sputum from individuals with early systemic or pneumonic infection is unknown. Due to the difficulty in obtaining clinical specimens, this assay was not evaluated with blood or sputum from individuals presenting with signs and symptoms of tularemia who have subsequently developed pneumonic or typhoidal tularemia pneumonic or typhoidal tularemia.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K131936 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131936: Jbaids Tularemia Detection Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131936
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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