510(k) · Cleared
ClearedJbaids Influenza a Subtyping 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 · OQW 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification
Cleared on Sep 13, 2011 as substantially equivalent to K080570 (Centers for Disease Control and Prevention, 2008) and 1 other predicate after an 82-day review. Its family tree reaches back 3 generations to 2006.
- Decided
- Sep 13, 2011
- Review
- 82 days
- Class
- Class II
- Product code
- OQW
- Recalls
- None
- Predicates
- 2
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 backK101564 CDC Influenza 2009 a (H1N1)PDM Real-Time RT-PCR PanelCenters for Disease Control and Prevention · 2010
- This deviceK111778 Jbaids Influenza a Subtyping KitU.S Army Medical Materiel Development Activity · 2011
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 | K101564 | CDC Influenza 2009 a (H1N1)PDM Real-Time RT-PCR Panel | Centers for Disease Control and Prevention | 2010 | — |
| 0 (this device) | K111778 | Jbaids Influenza a Subtyping Kit | U.S Army Medical Materiel Development Activity | 2011 | — |
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 OQW? 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 |
|---|---|---|---|
| * | K080570 | CDC Human Influenza Virus Real-Time RT- PCR Detection and Characterization PanelSummary page 3…substantially equivalent to the CDC Human Influenza Virus real-time RT-PCR Detection and Characterization Panel, which was cleared on September 30, 2008 under 5 10(k) # K080570, and the CDC Influenza 2009 A(H1Nl)pdmn Real- Time RT-PCR Panel, which was cleared on June 22, 2010 under 510(k) #101564. U.S… | 2008 |
| * | K101564 | CDC Influenza 2009 a (H1N1)PDM Real-Time RT-PCR PanelSummary page 4…CDC rRT-PCR Flu Panel A(HINI)pdm Flu Panel Subtyping Kit (K(080570) (K101564) Qualitative in vitro detection Qualitative in vitro detection of Qualitative in vitro detection of… | 2010 |
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 5 years and passes through 2 companies; a new generation was cleared every 1.7 years on median.
- None of the 4 ancestors has a recall.
- 7 other devices also cite its predicate K080570.
How does its category compare?
All OQW devicesOQW 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · OQW
3in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · OQW
39in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OQW
No recall names OQW since 2007.
Adverse event reports per year · OQW
1in 2011
MAUDE reports naming product code OQW, 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 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 3 | 22 | 0 | 0 |
| 2011 | 3 | 83 | 0 | 1 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 3 | 39 | 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) Influenza A Subtyping Kit is intended for the in vitro qualitative detection and differentiation of seasonal Influenza A/Hi, seasonal Influenza A/H3, and 2009 H INlIlnfluenza viral nucleic acids isolated and purified from nasopharyngeal swab (NPS) and nasopharyngeal wash (NPW) specimens from human patients with signs and symptoms of respiratory infection, in conjunction with…
Read the full statement (393 words)
The Joint Biological Agent Identification and Diagnostic System (JBAIDS) Influenza A Subtyping Kit is intended for the in vitro qualitative detection and differentiation of seasonal Influenza A/Hi, seasonal Influenza A/H3, and 2009 H INlIlnfluenza viral nucleic acids isolated and purified from nasopharyngeal swab (NPS) and nasopharyngeal wash (NPW) specimens from human patients with signs and symptoms of respiratory infection, in conjunction with clinical and epidemiological risk factors. The JBAIDS Influenza A Subtyping Kit contains reverse transcriptase real-time polymerase chain reaction (rRT-PCR) assays for use on the JBAIDS instruments. The Flu A HlI, Flu A H3, and Flu A Hi1 2009 assays of the MBAIDS Influenza A Subtyping Kit target a region of the hemnagglutinin (HA) gene of the respective Influenza A virus. The Flu A Sw assay of the JBAIDS Influenza A Subtyping Kit targets a region of the nucleocapsid protein (NP) gene of the 2009 H IN I Influenza virus, as well as some other Influenza A viruses of swine lineage. This kit is not intended to detect Influenza B or Influenza C viruses.
A negative result for all assays in the JBAIDS Influenza A Subtyping Kit is a presumptive negative result for Influenza A. These results should be confirmed using the JBAJDS Influenza A & B Detection Kit.
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.
Due to low seasonal prevalence, performance characteristics for detection of seasonal Influenza A/H I were established primarily with retrospective and contrived clinical specimens.
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K111778 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111778: Jbaids Influenza a Subtyping Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111778
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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