510(k) · Cleared
ClearedJbaids Influenza a/H5 Detection Kit, Model JRPD-Asy-0136
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
U.S. Army Medical Material Development Command · NXD Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna
Cleared on Jul 6, 2010 as substantially equivalent to K080570 (Centers for Disease Control and Prevention, 2008) after a 158-day review. Its family tree reaches back 2 generations to 2006.
- Decided
- Jul 6, 2010
- Review
- 158 days
- Class
- Class II
- Product code
- NXD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN060008 (2006). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backDEN060008 Influenza a/H5 (Asian Lineage) Virus Real-Time RT-PCR Primer and…Centers for Disease Control and Prevention · 2006
- 1 generation backK080570 CDC Human Influenza Virus Real-Time RT- PCR Detection and…Centers for Disease Control and Prevention · 2008
- This deviceK100287 Jbaids Influenza a/H5 Detection Kit, Model JRPD-Asy-0136U.S. Army Medical Material Development Command · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN060008 | Influenza a/H5 (Asian Lineage) Virus Real-Time RT-PCR Primer and Probe Set | Centers for Disease Control and Prevention | 2006 | — |
| −1 | K080570 | CDC Human Influenza Virus Real-Time RT- PCR Detection and Characterization Panel | Centers for Disease Control and Prevention | 2008 | — |
| 0 (this device) | K100287 | Jbaids Influenza a/H5 Detection Kit, Model JRPD-Asy-0136 | U.S. Army Medical Material Development Command | 2010 | — |
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 NXD? 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? (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 |
|---|---|---|---|
| * | K080570 | CDC Human Influenza Virus Real-Time RT- PCR Detection and Characterization PanelSummary page 5…ially equivalent to the Centers for Disease Control and Prevention (CDC) Human Influenza Virus Real-time RT-PCR Detection and Characterization Panel (rRT-PCR Flu Panel) (K080570). The CDC rRT-PCR Flu Panel is a panel of oligonucleotide primers and dual-labeled hydrolysis probes for the qualitative detecti… | 2008 |
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 4 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
- None of the 3 ancestors has a recall.
- 7 other devices also cite its predicate K080570.
How does its category compare?
All NXD devicesNXD Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · NXD
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · NXD
Too few NXD 510(k)s in any year since 2007 to give a median.
Recalls per year · NXD
No recall names NXD since 2007.
Adverse event reports per year · NXD
No MAUDE report names NXD 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 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 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 JBAIDS Influenza AIH5 (Asian lineage) Detection Kit is intended for use in real-time reverse-transcriptase polymerase chain reaction (rRT-PCR) assays on the Joint Biological Agent Identification and Diagnostic System (JBAIDS) instruments for the in vitro qualitative detection of Influenza A/F15 (Asian lineage) viral RNA in patient nasopharyngeal swab (NPS) or throat swab (TS) specimens for the presumptive laboratory identification of Influenza A/H5…
Read the full statement (329 words)
The JBAIDS Influenza AIH5 (Asian lineage) Detection Kit is intended for use in real-time reverse-transcriptase polymerase chain reaction (rRT-PCR) assays on the Joint Biological Agent Identification and Diagnostic System (JBAIDS) instruments for the in vitro qualitative detection of Influenza A/F15 (Asian lineage) viral RNA in patient nasopharyngeal swab (NPS) or throat swab (TS) specimens for the presumptive laboratory identification of Influenza A/H5 (Asian lineage) virus.
Testing with the JBAIDS Influenza A/H-5 (Asian lineage) Detection Kit should be in conjunction with other laboratory testing and clinical observations for the following indications:
1. Providing epidemiological information for the surveillance of human infection with Influenza A/H5 (Asian lineage) virus.
2. Identifying patients who may be infected with Influenza AIH5 (Asian lineage) virus based on clinical and epidemiological risk factors.
Testing with the JBAIDS Influenza AIH5 (Asian lineage) Detection Kit should not be performed unless the patient meets the most current U.S. Department of Health and Human Services (DHHS) clinical and epidemniologic criteria for testing suspected A/H5 specimens.
The definitive identification of influenza A/H-5 (Asian lineage) either directly from patient specimens or from virus cultures requires additional laboratory testing, along with clinical and epidemiological assessment in consultation with national influenza surveillance experts.
Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions.
Use is limited to laboratories with appropriate biosafety equipment and containment procedures. It is intended for use by experienced laboratory personnel who have training in standardized molecular testing procedures and expertise in viral diagnosis, and have received training on the JBAIDS Instrument.
If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteriarecommended by public health authorities, specimens should be collected with appropriateinfection control precautionsfor novel virulent influenza viruses and sent to state or local health departmentsfor 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/K100287 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100287: Jbaids Influenza a/H5 Detection Kit, Model JRPD-Asy-0136.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100287
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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