# K103776: Xtag Respiratory Viral Panel Fast, Xtag Data Analysis Software for RVP Fast

- Pathway: 510(k) (Traditional)
- Applicant: Luminex Molecular Diagnostics, Inc.
- Decided: Jul 1, 2011 after 186 days
- Product code: OCC (Respiratory Virus Panel Nucleic Acid Assay System)
- Device class: 2
- Regulation: 21 CFR 866.3980
- 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 DEN070013 (2008). 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)
- DEN070013: ID-Tag Respiratory Viral Panel, Luminex Molecular Diagnostics, Inc. (2008). Our reading of the summary gave K063765, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN070013, ID-Tag Respiratory Viral Panel (Luminex Molecular Diagnostics, Inc.), granted Jan 3, 2008; older De Novo requests were first filed under a 510(k) number, so this links to the grant.
- K081483: Xtag Respiratory Viral Panel, Luminex Molecular Diagnostics, Inc. (2008). Our reading of the summary gave K081843, FDA’s number for Ultrasound Data Analysis System, Model Das-RS1 (Aloka Co., Ltd.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “xTAG Respiratory Viral Panel”. Summary page 3.
- K091667: Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112, I019E0113, S019-0116, Luminex Molecular Diagnostics, Inc. (2009) Summary page 3.

## Indications for use
The xTAG®&Respiratory Viral Panel Fast (RVP FAST) isa qualitative nucleic acid multiplex test intended for the simultaneous detection and identification of multiple respiratory virus nucleic acids in nasopharyngeal swabs from individuals suspected of respiratory tract infections..The following virus types and subtypes are identified using RVP FAST: Influenza A, Influenza A subtype Hi, Influenza A subtype H3, Influenza B, Respiratory Syncytial Virus, Human Metapneumovirus, Rhinovirus, and Adenovirus. The detection and identification of specific viral nucleic acids from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection if used in conjunction with other clinical and epidemiological information. Negative results do not preclude respiratory viral infection and should not be used as the sole basis for diagnosis, treatment or other management decisions. Positive results do not rule out bacterial infection, or co-infection with other organisms. The agent detected may not be the definite cause of disease. The use of additional laboratory testing (e.g., bacterial and viral culture, immunofluorescence, and radiography) and clinical presentation-must-be taken into consideration in order to obtain the final diagnosis of respiratory infection. Due to the genetic similarity between human Rhinovirus and Enterovirus, the RVP FAST primers for the detection of rhinovirus cross-react with enterovirus. A rhinovirus reactive result should be confirmed by an alternate method (e.g., cell culture). Performance characteristics for Influenza A Virus were established when Influenza A/H3 and A/Hi were the predominant Influenza A viruses in circulation. When other Influenza Aviruses are emerging, performance characteristics may vary. 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 a state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

Source page: https://510kreport.com/device/K103776
Methodology: https://510kreport.com/methodology