510(k) · Cleared
ClearedXtag Respiratory Viral Panel Fast, Xtag Data Analysis Software for RVP Fast
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Luminex Molecular Diagnostics, Inc. · OCC Respiratory Virus Panel Nucleic Acid Assay System
Cleared on Jul 1, 2011 as substantially equivalent to DEN070013 (Luminex Molecular Diagnostics, Inc., 2008) and 2 other predicates after a 186-day review. Its family tree reaches back 3 generations to 2008.
- Decided
- Jul 1, 2011
- Review
- 186 days
- Class
- Class II
- Product code
- OCC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to DEN070013 (2008). No later device cites it as a predicate yet.
- Root · 3 generations backDEN070013 ID-Tag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008
- 2 generations backK081483 Xtag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008 · Recalled
- 1 generation backK091667 Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112…Luminex Molecular Diagnostics, Inc. · 2009 · Recalled
- This deviceK103776 Xtag Respiratory Viral Panel Fast, Xtag Data Analysis Software for…Luminex Molecular Diagnostics, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN070013 | ID-Tag Respiratory Viral Panel | Luminex Molecular Diagnostics, Inc. | 2008 | — |
| −2 | K081483 | Xtag Respiratory Viral Panel | Luminex Molecular Diagnostics, Inc. | 2008 | 1 |
| −1 | K091667 | Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112… | Luminex Molecular Diagnostics, Inc. | 2009 | 1 |
| 0 (this device) | K103776 | Xtag Respiratory Viral Panel Fast, Xtag Data Analysis Software for RVP Fast | Luminex Molecular Diagnostics, Inc. | 2011 | — |
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 OCC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OCC device
- #1 K262747 ID NOW Influenza A & B 2; ID NOW RSV; ID NOW…score 15.2 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | DEN070013 | ID-Tag Respiratory Viral Panel 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. | 2008 |
| * | K081483 | Xtag Respiratory Viral Panel 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”. | 2008 |
| * | K091667 | Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112, I019E0113, S019-0116Summary page 3…onal 510(k) Submission Substantial Equivalence Information: a. Predicate device name(s): xTAG Respiratory Viral Panel b. Predicate 510(k) number(s): k063765, k081843, k091667 c. Comparison with predicate: The following tables compare the xTAG Respiratory Viral Panel FAST with the xTAG Respiratory Viral… | 2009 |
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 3 years and passes through 1 company; a new generation was cleared every 12 months on median.
- 2 of the 3 ancestors have a recall of any class.
- 11 other devices also cite its predicate DEN070013.
How does its category compare?
All OCC devicesOCC Respiratory Virus Panel Nucleic Acid Assay System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · OCC
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · OCC
31in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OCC
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OCC
2in 2025
MAUDE reports naming product code OCC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 4 | 28 | 0 | 0 |
| 2009 | 6 | 24 | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 9 | 82 | 0 | 2 |
| 2012 | 6 | 125 | 0 | 1 |
| 2013 | 6 | 79 | 0 | 0 |
| 2014 | 4 | 94 | 1 | 52 |
| 2015 | 8 | 85 | 0 | 1 |
| 2016 | 7 | 92 | 0 | 36 |
| 2017 | 10 | 136 | 0 | 1 |
| 2018 | 4 | 134 | 1 | 1 |
| 2019 | 5 | 31 | 1 | 2 |
| 2020 | 2 | — | 0 | 17 |
| 2021 | 1 | — | 0 | 686 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 2 | — | 0 | 1 |
| 2024 | 1 | — | 1 | 3 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 3 | 130 | 0 | — |
What is it indicated for?
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…
Read the full statement (316 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103776 · printed Nov 4, 2026
Cite this page
510(k) Report. “K103776: Xtag Respiratory Viral Panel Fast, Xtag Data Analysis Software for RVP Fast.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K103776
Report an extraction error
Are you the manufacturer?
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