# K131930: Jbaids Anthrax Detection Kit

- Pathway: 510(k) (Traditional)
- Applicant: Biofire Diagnostics, Inc.
- Decided: Aug 5, 2013 after 39 days
- Product code: NHT (Assay, Nucleic Acid Amplification, Bacillus Anthracis)
- Device class: 2
- Regulation: 21 CFR 866.3045
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K922906 (1993). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051713: Jbaids Anthrac Detection System, Idaho Technology, Inc. (2005) Summary page 1.
- K071188: Modification to Jbaids Anthrax Detection System, Idaho Technology, Inc. (2007) Summary page 1.

## Recalls of this device
- Aug 13, 2014 · Class III · Z-2644-2014: 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.

## Indications for use
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.

Source page: https://510kreport.com/device/K131930
Methodology: https://510kreport.com/methodology