510(k) · Cleared
Recalled · Class III · 2014Jbaids Anthrax Detection Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biofire Diagnostics, Inc. · NHT Assay, Nucleic Acid Amplification, Bacillus Anthracis
Cleared on Aug 5, 2013 as substantially equivalent to K051713 (Idaho Technology, Inc., 2005) and 1 other predicate after a 39-day review. Its family tree reaches back 6 generations to 1993. It has been recalled once.
- Decided
- Aug 5, 2013
- Review
- 39 days
- Class
- Class II
- Product code
- NHT
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 6 generations to K922906 (1993). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK922906 Amplicor Chlamydia Trachomatis TestRoche Molecular Systems, Inc. · 1993
- 5 generations backK964506 Roche Cobas Amplicor AnalyzerRoche Molecular Systems, Inc. · 1997 · Recalled
- 4 generations backK012966 Roche Cobas Taqman AnalyzerRoche Molecular Systems, Inc. · 2002 · Recalled
- 3 generations backK033734 Lightcycler Instrument Version 1.2Roche Diagnostics Corp. · 2003 · Recalled
- 2 generations backK051713 Jbaids Anthrac Detection SystemIdaho Technology, Inc. · 2005
- 1 generation backK071188 Modification to Jbaids Anthrax Detection SystemIdaho Technology, Inc. · 2007
- This deviceK131930 Jbaids Anthrax Detection KitBiofire Diagnostics, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K922906 | Amplicor Chlamydia Trachomatis Test | Roche Molecular Systems, Inc. | 1993 | — |
| −5 | K964506 | Roche Cobas Amplicor Analyzer | Roche Molecular Systems, Inc. | 1997 | 1 |
| −4 | K012966 | Roche Cobas Taqman Analyzer | Roche Molecular Systems, Inc. | 2002 | 3 |
| −3 | K033734 | Lightcycler Instrument Version 1.2 | Roche Diagnostics Corp. | 2003 | 1 |
| −2 | K051713 | Jbaids Anthrac Detection System | Idaho Technology, Inc. | 2005 | — |
| −1 | K071188 | Modification to Jbaids Anthrax Detection System | Idaho Technology, Inc. | 2007 | — |
| 0 (this device) | K131930 | Jbaids Anthrax Detection Kit | Biofire Diagnostics, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 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 NHT? 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? (2)
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 |
|---|---|---|---|
| * | K051713 | Jbaids Anthrac Detection SystemSummary page 1…Number: 21 CFR 866.3045 Classification Name: Reagent Kit: B. anthracis, Class 11 Product Code: NHT Predicate Device: JBAIDS Anthrax Detection Kit (K05 1713 and K071 188) Intended Use: The Joint Biological Agent Identification and Diagnostic System (JBAIDS) Anthrax Detec… | 2005 |
| * | K071188 | Modification to Jbaids Anthrax Detection SystemSummary page 1…FR 866.3045 Classification Name: Reagent Kit: B. anthracis, Class 11 Product Code: NHT Predicate Device: JBAIDS Anthrax Detection Kit (K05 1713 and K071 188) Intended Use: The Joint Biological Agent Identification and Diagnostic System (JBAIDS) Anthrax Detection System i… | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 13, 2014 | Class III | Z-2644-2014 | Software Manufacturing/Software Deployment | BioFire Defense, LLC is initiating a field action for JBAIDS Software version 3.5.0.72 because the wrong version software may have been installed. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 3.9 years on median.
- 4 of the 8 ancestors have a recall of any class.
- 2 other devices also cite its predicate K051713.
How does its category compare?
All NHT devicesNHT Assay, Nucleic Acid Amplification, Bacillus Anthracis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · NHT
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · NHT
Too few NHT 510(k)s in any year since 2007 to give a median.
Recalls per year · NHT
No recall names NHT since 2007.
Adverse event reports per year · NHT
1in 2021
MAUDE reports naming product code NHT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 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 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Joint Biological Agent Identification and Diagnostic System (JBAIDS) Anthrax Detection System is a real-time polymerase chain reaction (PCR) test system intended for the qualitative in vitro diagnostic (IVD) detection of target DNA sequences on the pXO I plasmid (Target 1) and the pXO2 plasmid (Target 2) from Bacillus anthracis. The system can be used to test the following: Human whole blood collected in sodium citrate from individuals suspected of…
Read the full statement (304 words)
The Joint Biological Agent Identification and Diagnostic System (JBAIDS) Anthrax Detection System is a real-time polymerase chain reaction (PCR) test system intended for the qualitative in vitro diagnostic (IVD) detection of target DNA sequences on the pXO I plasmid (Target 1) and the pXO2 plasmid (Target 2) from Bacillus anthracis. The system can be used to test the following:
Human whole blood collected in sodium citrate from individuals suspected of having anthrax
Positive blood cultures
Cultured organisms grown on blood agar plates.
The JBAIDS Anthrax Target 2 assay is used as a supplementary test only after a positive result with the Target I Assay.
The JBAIDS Anthrax Target I and Target 2 Assays are run on the JBAIDS instrument using the Diagnostic Wizard. Results are for the presumptive identification of B. anthracis, in conjunction with culture and other laboratory tests. The following considerations also apply:
The diagnosis of anthrax infection must be made based on history, signs, symptoms, exposure likelihood, and other laboratory evidence, in addition to the identification of pXOI and pXO2 targets either from cultures or from direct blood specimens.
The assays have not been evaluated with blood from individuals without clinical signs or symptoms who were presumed exposed and who subsequently developed anthrax (inhalation or other forms of the disease), or from individuals with any form of anthrax (inhalational, cutaneous, or gastrointestinal).
The level of plasmid targets that would be present in blood from individuals with early systemic infection is unknown.
The definitive identification of B. anthracis from colony growth, liquid blood culture growth, or from blood specimens requires additional testing and confirmation procedures in consultation with public health or other authorities for whom reports are required.
The safety and effectiveness of other types of tests or sample types (not identified as "For in vitro diagnostic use") have not been established.
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/K131930 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131930: Jbaids Anthrax 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/K131930
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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