510(k) · Cleared
ClearedJbaids Q Fever Detection Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Idaho Technology, Inc. · OVF Assay, Direct, Nucleic Acid Amplification, Q Fever
Cleared on May 20, 2011 as substantially equivalent to K922374 (Hillcrest Biologicals, 1992) and 1 other predicate after a 200-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- May 20, 2011
- Review
- 200 days
- Class
- Class I
- Product code
- OVF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K922374 (1992). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK922374 Q Fever Igm Ifa TestHillcrest Biologicals · 1992
- This deviceK103207 Jbaids Q Fever Detection KitIdaho Technology, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K922374 | Q Fever Igm Ifa Test | Hillcrest Biologicals | 1992 | — |
| 0 (this device) | K103207 | Jbaids Q Fever Detection Kit | Idaho Technology, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 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 OVF? 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 |
|---|---|---|---|
| * | K922374 | Q Fever Igm Ifa TestSummary page 4…under K05 1713. The predicate for the JBAIDS Q Fever Detection Kit is the Focus Diagnostics 1gM and IgG IFA tests cleared under K922374 and K91 3906. The following table compares the JBAIDS Q Fever Detection System with the p… | 1992 |
| * | K913906 | Q Fever Igg Ifa TestSummary page 4…713. The predicate for the JBAIDS Q Fever Detection Kit is the Focus Diagnostics 1gM and IgG IFA tests cleared under K922374 and K91 3906. The following table compares the JBAIDS Q Fever Detection System with the predicate test… | 1992 |
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All OVF devicesOVF Assay, Direct, Nucleic Acid Amplification, Q Fever: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · OVF
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · OVF
Too few OVF 510(k)s in any year since 2007 to give a median.
Recalls per year · OVF
No recall names OVF since 2007.
Adverse event reports per year · OVF
No MAUDE report names OVF 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 | 1 | — | 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 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (363 words)
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.
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/K103207 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103207: Jbaids Q Fever 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/K103207
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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