# K100287: Jbaids Influenza a/H5 Detection Kit, Model JRPD-Asy-0136

- Pathway: 510(k) (Traditional)
- Applicant: U.S. Army Medical Material Development Command
- Decided: Jul 6, 2010 after 158 days
- Product code: NXD (Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna)
- Device class: 2
- Regulation: 21 CFR 866.3332
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN060008 (2006). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080570: CDC Human Influenza Virus Real-Time RT- PCR Detection and Characterization Panel, Centers for Disease Control and Prevention (2008) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K100287
Methodology: https://510kreport.com/methodology