510(k) · Cleared
ClearedFilmarray Respiratory Panel (RP)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Idaho Technology, Inc. · OCC Respiratory Virus Panel Nucleic Acid Assay System
Cleared on Feb 17, 2011 as substantially equivalent to DEN070013 (Luminex Molecular Diagnostics, Inc., 2008) and 2 other predicates after a 112-day review. Its family tree reaches back 3 generations to 2008. 23 later devices descend from it.
- Decided
- Feb 17, 2011
- Review
- 112 days
- Class
- Class II
- Product code
- OCC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to DEN070013 (2008). 23 later devices descend from it, 5 citing it directly.
- 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 deviceK103175 Filmarray Respiratory Panel (RP)Idaho Technology, Inc. · 2011
- Descendant · cites it directly · 21 of its ownK120267 Filmarray RP PanelIdaho Technology, Inc. · 2012
- Descendant · cites it directly · 18 of its ownK123620 Filmarray Respiratory Panel (RP)Biofire Diagnostics, Inc. · 2013
- Descendant · 2 generations on · 10 of its ownK143080 FilmArray Respiratory Panel (RP) for use with Multi-instrument…Biofire Diagnostics, LLC · 2015
- Descendant · 3 generations on · 6 of its ownK160068 FilmArray Respiratory Panel (RP) for use with FilmArray TorchBiofire Diagnostics, LLC · 2016 · Recalled
- Descendant · cites it directly · 5 of its ownK133673 Illumigene Pertusis Dna Amplification Assay, Illumigene Pertussis…Meridian Bioscience, Inc. · 2014
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K120267Filmarray RP PanelIdaho Technology, Inc. · 2012 · cites it directly21descendants
- K123620Filmarray Respiratory Panel (RP)Biofire Diagnostics, Inc. · 2013 · cites it directly18descendants
- K143080FilmArray Respiratory Panel (RP) for use with Multi-instrument FilmArray SystemBiofire Diagnostics, LLC · 2015 · 2 generations on10descendants
- K160068FilmArray Respiratory Panel (RP) for use with FilmArray TorchBiofire Diagnostics, LLC · 2016 · 3 generations on6descendants
- K133673Illumigene Pertusis Dna Amplification Assay, Illumigene Pertussis External Control Kit…Meridian Bioscience, Inc. · 2014 · cites it directly5descendants
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) | K103175 | Filmarray Respiratory Panel (RP) | Idaho Technology, Inc. | 2011 | — |
| +1 | K120267 | Filmarray RP Panel | Idaho Technology, Inc. | 2012 | — |
| +1 | K123620 | Filmarray Respiratory Panel (RP) | Biofire Diagnostics, Inc. | 2013 | — |
| +2 | K143080 | FilmArray Respiratory Panel (RP) for use with Multi-instrument FilmArray System | Biofire Diagnostics, LLC | 2015 | — |
| +3 | K160068 | FilmArray Respiratory Panel (RP) for use with FilmArray Torch | Biofire Diagnostics, LLC | 2016 | 1 |
| +1 | K133673 | Illumigene Pertusis Dna Amplification Assay, Illumigene Pertussis External… | Meridian Bioscience, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 5 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
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 PanelSummary page 1…RP System Regulation Number: 21 CFR 866.3980 Classification Name: Respiratory Viral Panel Multiplex Nucleic Acid Assay Predicate Device: K063765, K08 1483, K09 1677 - LuminexO xTAGTM Respiratory Viral Panel (RVP). Intended Use: The FilmArray Respiratory Panel (RP) is a multi… | 2008 |
| * | K091667 | Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112, I019E0113, S019-0116 Our OCR of the scanned summary read K091677, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Luminex xTAG Respiratory Viral Panel (RVP)”. | 2009 |
What descends from it? (23)
See all 235 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120267 | Filmarray RP Panel | 2012 | 21 |
| K123620 | Filmarray Respiratory Panel (RP) | 2013 | 18 |
| K133673 | Illumigene Pertusis Dna Amplification Assay, Illumigene Pertussis External Control Kit… | 2014 | 5 |
| K143653 | Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) | 2015 | 1 |
| K143178 | FilmArray 2.0 System | 2015 | 0 |
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 2 companies; a new generation was cleared every 12 months on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K120267 (Idaho Technology, Inc., 2012) has gone furthest, with 21 descendants of its own.
- 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 FilmArray Respiratory Panel (RP) is a multiplexed nucleic acid test intended for use with the FilmArray instrument for the simultaneous qualitative detection and identification of multiple respiratory viral nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infections. The following virus types and subtypes are identified using the FilmArray RP: Adenovirus, Coronavirus HKU1, Coronavirus NL63, Human…
Read the full statement (405 words)
The FilmArray Respiratory Panel (RP) is a multiplexed nucleic acid test intended for use with the FilmArray instrument for the simultaneous qualitative detection and identification of multiple respiratory viral nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infections. The following virus types and subtypes are identified using the FilmArray RP: Adenovirus, Coronavirus HKU1, Coronavirus NL63, Human Metapneumovirus, Influenza A, Influenza A subtype H1, Influenza A subtype H3, Influenza A subtype 2009 H1, Influenza B, Parainfluenza virus 3, Rhinovirus/Enterovirus, and Respiratory Syncytial Virus. The detection and identification of specific viral nucleic acids from individuals exhibiting signs and symptoms of a respiratory infection aids in the diagnosis of respiratory infection if used in conjunction with other clinical and epidemiological information. Negative results do not preclude respiratory 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 seasonal prevalence, performance characteristics for Influenza A/H1, Influenza A/H3, Influenza A/2009 H1, and Influenza B were established primarily with retrospective clinical specimens.
Due to the genetic similarity between human Rhinovirus and Enterovirus, the FilmArray RP cannot reliably differentiate them. A positive FilmArray RP Rhinovirus/Enterovirus result should be followed-up using an alternate method (e.g. cell culture or sequence analysis).
The FilmArray RP detects Adenovirus species C serotype 6 with reduced sensitivity. It is recommended that specimens found to be negative for Adenovirus after examination using FilmArray RP be confirmed by an alternate method (e.g. FDA cleared molecular test or cell culture).
Performance characteristics for influenza A were established when influenza A/2009 H1N1, A/H1, and A/H3 were the predominant influenza A viruses 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 state or local health departments 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K103175 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103175: Filmarray Respiratory Panel (RP).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103175
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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