510(k) Report

510(k) · Cleared

Cleared

Xtag Respiratory Viral Panel Fast, Xtag Data Analysis Software for RVP Fast

K103776510(k) TraditionalCleared Jul 1, 2011186-day reviewClass II21 CFR 866.3980

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

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.

  1. Root · 3 generations backDEN070013 ID-Tag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008
  2. 2 generations backK081483 Xtag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008 · Recalled
  3. 1 generation backK091667 Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112…Luminex Molecular Diagnostics, Inc. · 2009 · Recalled
  4. 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

GenerationNumberDeviceApplicantDecidedRecalls
−3DEN070013ID-Tag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc.2008—
−2K081483Xtag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc.20081
−1K091667Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112…Luminex Molecular Diagnostics, Inc.20091
0 (this device)K103776Xtag Respiratory Viral Panel Fast, Xtag Data Analysis Software for RVP FastLuminex Molecular Diagnostics, Inc.2011—
FIG. 1 — Lineage of K103776, 2008–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K262747 ID NOW Influenza A & B 2; ID NOW RSV; ID NOW…score 15.2 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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.

TypeNumberDeviceApplicantDecidedRecalls
*DEN070013ID-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.
Luminex Molecular Diagnostics, Inc.2008—
*K081483Xtag 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”.
Luminex Molecular Diagnostics, Inc.20081
*K091667Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112, I019E0113, S019-0116
Summary 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…
Luminex Molecular Diagnostics, Inc.20091

Also cleared against DEN070013: 11 other devices →

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 devices

OCC 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

2008: 42009: 62010: 22011: 92012: 62013: 62014: 42015: 82016: 72017: 102018: 42019: 52020: 22021: 12022: 12023: 22024: 12026 (partial year): 3
2007high 10 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OCC

31in 2019

2008: 28 days median2009: 24 days median2011: 82 days median2012: 125 days median2013: 79 days median2014: 94 days median2015: 85 days median2016: 92 days median2017: 136 days median2018: 134 days median2019: 31 days median2026 (partial year): 130 days median
2007high 136 (2017) · low 24 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · OCC

1in 2024

2014: 12018: 12019: 12024: 1
2007high 1 (2014) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OCC

2in 2025

2011: 22012: 12014: 522015: 12016: 362017: 12018: 12019: 22020: 172021: 6862022: 22023: 12024: 32025: 2
2007high 686 (2021) · low 0 (2007)2025

MAUDE reports naming product code OCC, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
200842800
200962400
20102—00
201198202
2012612501
201367900
2014494152
201588501
2016792036
20171013601
2018413411
201953112
20202—017
20211—0686
20221—02
20232—01
20241—13
20250—02
202631300—

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.

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

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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