# K111778: Jbaids Influenza a Subtyping Kit

- Pathway: 510(k) (Traditional)
- Applicant: U.S Army Medical Materiel Development Activity
- Decided: Sep 13, 2011 after 82 days
- Product code: OQW (2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification)
- 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: 3 generations back to DEN060008 (2006). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 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 3.
- K101564: CDC Influenza 2009 a (H1N1)PDM Real-Time RT-PCR Panel, Centers for Disease Control and Prevention (2010) Summary page 4.

## Indications for use
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.

Source page: https://510kreport.com/device/K111778
Methodology: https://510kreport.com/methodology