# K103207: Jbaids Q Fever Detection Kit

- Pathway: 510(k) (Traditional)
- Applicant: Idaho Technology, Inc.
- Decided: May 20, 2011 after 200 days
- Product code: OVF (Assay, Direct, Nucleic Acid Amplification, Q Fever)
- Device class: 1
- Regulation: 21 CFR 866.3500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K922374 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922374: Q Fever Igm Ifa Test, Hillcrest Biologicals (1992) Summary page 4.
- K913906: Q Fever Igg Ifa Test, Hillcrest Biologicals (1992) Summary page 4.

## Indications for use
The Joint Biological Agent Identification and Diagnostic System (JBAIDS) Q Fever Detection Kit is a qualitative real-time polymerase chain reaction (PCR) test kit intended to identify and detect target DNA sequence from Coxiella burnetii in serum collected from individuals suspected of having acute Q fever, typically 7-10 days after onset of symptoms or before antibody formation. This in vitro diagnostic (IVD) test is intended to aid in the diagnosis of Q fever in individuals presenting with signs and symptoms of acute Q fever when used in conjunction with other clinical and laboratory findings. This kit is only intended to aid in the diagnosis of Q fever of patients presenting in the acute stage of the disease. Negative results do not preclude C. burnetii infection and should not be used as the sole basis for diagnosis, treatment or other management decisions. The JBAIDS Q Fever assay is run on the JBAIDS instrument using the Diagnostic Wizard. Results are for the presumptive identification of C. burnetli in conjunction with serology and/or other laboratory tests. The following considerations also apply: * The diagnosis of acute Q fever must be made based on history, signs, symptoms, exposure likelihood, and other laboratory evidence, in addition to the identification of C burnetii from serum specimens. * Sensitivity is decreased by -25-40%, with no change in specificity, if the sample is collected after the patient has formed specific antibodies to C burnetii, typically 7- 10 days after onset of symptoms. * The definitive identification of C burnetii from serum specimens requires additional testing and confirmation procedures in consultation with public health or other authorities for whom reports are required. The test performance characteristics for this system were established with banked, frozen serum specimens that were sequentially received during a specified time period. The safety and effectiveness of other types of tests or sample types have not been established. All users, analysts, and any person reporting diagnostic results from use of this device should be trained to perform and interpret the results from this procedure by JBAIDS instructors or designees prior to use. Use of this device is limited to designated Department of Defense (DoD) laboratories equipped with the JBAIDS instruments.

Source page: https://510kreport.com/device/K103207
Methodology: https://510kreport.com/methodology