# K112781: Tag Respiratory Viral Panel Tag Data Analysis Software (Tdas RVP-I)

- Pathway: 510(k) (Traditional)
- Applicant: Luminex Molecular Diagnostics, Inc.
- Decided: Feb 17, 2012 after 144 days
- Product code: OCC (Respiratory Virus Panel Nucleic Acid Assay System)
- Device class: 2
- Regulation: 21 CFR 866.3980
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to DEN070013 (2008). 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)
- 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 2.
- K112199: Xtag Respiratory Viral Panel, Xtag Data Analysis Software (Tdas RVP-1), Luminex Molecular Diagnostics, Inc. (2011) Summary page 1.

## Recalls of this device
- Jul 16, 2019 · Class II · Z-0161-2020: The Assay may give a false negative result when detecting and subtyping Influenza A (H3) and detecting RSV A in patient specimens. However, the assay will continue to detect Influenza A, Influenza B, 

## Indications for use
The xTAG' Respiratory Viral Panel (RVP) is a 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: Influenza A, Influenza B, Respiratory Syncytial Virus subtype A, Respiratory Syncytial Virus subtype B, Parainfluenza 1, Parainfluenza 2, and Parainfluenza 3 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 laboratory findings. xTAG RVP can also differentiate the hemagglutinin (HA) gene of some Influenza A subtypes HI and H3 strains. Differentiation of Influenza A HA subtypes is based on both a positive result for the Influenza A matrix gene and an accompanying positive result for the Influenza A HA subtype HI (circulating prior to the emergence of 2009 HINlpdm) or Influenza A HA subtype H3. This device cannot differentiate the Influenza A HA subtype 2009 HlNlpdm by design, and may not be able to differentiate potential newly emerging Influenza A HA subtypes. Positive results do not rule out bacterial infection, or co-infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing (e.g. bacterial culture, immunofluorescence, radiography) and clinical presentation must be taken into consideration in order to obtain the final diagnosis of respiratory viral infection. Negative results do not preclude respiratory virus infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. The RVP assay cannot adequately detect Adenovirus species C, or serotypes 7a and 41.. It is recommended that specimens found to be negative for Adenovirus after examination using RVP be confirmed by an alternate method (e.g., FDA cleared molecular test or cell culture). The RVP primers for 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 HA subtype H3, subtype HI (prior to the emergence of 2009 HI Nlpdm), and when subtype 2009 HINlIpdmn were the predominant Influenza A in circulation. When other Influenza A viruses 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/K112781
Methodology: https://510kreport.com/methodology