510(k) · Cleared
ClearedJBAIDS Influenza A & B Detection Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
U.S Army Medical Materiel Development Activity · OCC Respiratory Virus Panel Nucleic Acid Assay System
Cleared on Oct 1, 2015 as substantially equivalent to K111775 (U.S. Army Medical Material Development Acitvity, 2011) after a 28-day review. Its family tree reaches back 3 generations to 2006.
- Decided
- Oct 1, 2015
- Review
- 28 days
- Class
- Class II
- Product code
- OCC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN060008 (2006). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backDEN060008 Influenza a/H5 (Asian Lineage) Virus Real-Time RT-PCR Primer and…Centers for Disease Control and Prevention · 2006
- 2 generations backK080570 CDC Human Influenza Virus Real-Time RT- PCR Detection and…Centers for Disease Control and Prevention · 2008
- 1 generation backK111775 Jbaids Influenza a&B Detection KitU.S. Army Medical Material Development Acitvity · 2011
- This deviceK152523 JBAIDS Influenza A & B Detection KitU.S Army Medical Materiel Development Activity · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN060008 | Influenza a/H5 (Asian Lineage) Virus Real-Time RT-PCR Primer and Probe Set | Centers for Disease Control and Prevention | 2006 | — |
| −2 | K080570 | CDC Human Influenza Virus Real-Time RT- PCR Detection and Characterization Panel | Centers for Disease Control and Prevention | 2008 | — |
| −1 | K111775 | Jbaids Influenza a&B Detection Kit | U.S. Army Medical Material Development Acitvity | 2011 | — |
| 0 (this device) | K152523 | JBAIDS Influenza A & B Detection Kit | U.S Army Medical Materiel Development Activity | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 OCC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OCC device
- #1 K262747 ID NOW Influenza A & B 2; ID NOW RSV; ID NOW…score 15.2 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K111775 | Jbaids Influenza a&B Detection KitSummary page 6…nfluenza A H3N2v and H7N9 strains described is substantially equivalent to the JBAIDS Influenza A & B Detection Kit, which was cleared on September 13, 2011 under 510(k) K111775. 15 DEPARTMENT OF THE ARMY… | 2011 |
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 9 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All OCC devicesOCC Respiratory Virus Panel Nucleic Acid Assay System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · OCC
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · OCC
31in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OCC
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OCC
2in 2025
MAUDE reports naming product code OCC, 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 | 0 | — | 0 | 0 |
| 2008 | 4 | 28 | 0 | 0 |
| 2009 | 6 | 24 | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 9 | 82 | 0 | 2 |
| 2012 | 6 | 125 | 0 | 1 |
| 2013 | 6 | 79 | 0 | 0 |
| 2014 | 4 | 94 | 1 | 52 |
| 2015 | 8 | 85 | 0 | 1 |
| 2016 | 7 | 92 | 0 | 36 |
| 2017 | 10 | 136 | 0 | 1 |
| 2018 | 4 | 134 | 1 | 1 |
| 2019 | 5 | 31 | 1 | 2 |
| 2020 | 2 | — | 0 | 17 |
| 2021 | 1 | — | 0 | 686 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 2 | — | 0 | 1 |
| 2024 | 1 | — | 1 | 3 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 3 | 130 | 0 | — |
What is it indicated for?
The Joint Biological Agent Identification and Diagnostic System (JBAIDS) Influenza A & B Detection Kit is intended for use on the JBAIDS instruments, for the in vitro qualitative detection of influenza A and influenza B viral nucleic acids isolated and purified NPS and NPW specimens from human patients with signs and symptoms of respiratory infection. The JBAIDS Influenza A & B Detection Kit contains reverse transcriptase real-time polymerase chain…
Read the full statement (322 words)
The Joint Biological Agent Identification and Diagnostic System (JBAIDS) Influenza A & B Detection Kit is intended for use on the JBAIDS instruments, for the in vitro qualitative detection of influenza A and influenza B viral nucleic acids isolated and purified NPS and NPW specimens from human patients with signs and symptoms of respiratory infection.
The JBAIDS Influenza A & B Detection Kit contains reverse transcriptase real-time polymerase chain reaction (rRT-PCR) assays that target the Matrix protein gene of influenza A viruses, and the Non-structural protein gene of influenza B viruses. This kit is not intended to detect influenza C viruses.
Test results are to be used in conjunction with other clinical and epidemiological information. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions.
Performance characteristics for detection of influenza A were established when 2009 H1N1 Influenza, Influenza A H1N1, and Influenza A H3N2 were the predominant influenza A viruses in circulation. Due to low seasonal prevalence, performance characteristics for detection of seasonal Influenza A/H1 were established primarily with retrospective and surrogate clinical specimens. When other influenza A viruses are present, performance characteristics may vary. 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.
If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health departments for testing. Viral culture should not be attempted in these cases unless a biosafety laboratory (BSL) 3+ facility is available to receive and culture specimens.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152523 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152523: JBAIDS Influenza A & B 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/K152523
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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