510(k) · Cleared
ClearedModification to Proflu+ Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prodesse, Inc. · OCC Respiratory Virus Panel Nucleic Acid Assay System
Cleared on Aug 20, 2009 as substantially equivalent to K081030 (Prodesse, Inc., 2008) and 1 other predicate after a 6-day review. Its family tree reaches back 3 generations to 2008. 41 later devices descend from it.
- Decided
- Aug 20, 2009
- Review
- 6 days
- Class
- Class II
- Product code
- OCC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to DEN070013 (2008). 5 ancestors in all. 41 later devices descend from it, 10 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 deviceK092500 Modification to Proflu+ AssayProdesse, Inc. · 2009
- Descendant · cites it directly · 15 of its ownK110968 Proflu+ AssayGen-Probe Prodesse, Inc. · 2011
- Descendant · 2 generations on · 13 of its ownK132129 Prodesse Proflu+ AssayGen-Probe Prodesse, Inc. · 2013
- Descendant · cites it directly · 7 of its ownK131813 Quidel Molecular RSV + HMPV AssayQuidel Corp. · 2013
- Descendant · 2 generations on · 5 of its ownK142045 Xpert Flu/RSV XC AssayCepheid · 2014
- Descendant · cites it directly · 5 of its ownK101855 Profast+ AssayGen-Probe Prodesse, Inc. · 2010
Showing 5 of 41 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 41 · See all- K110968Proflu+ AssayGen-Probe Prodesse, Inc. · 2011 · cites it directly15descendants
- K132129Prodesse Proflu+ AssayGen-Probe Prodesse, Inc. · 2013 · 2 generations on13descendants
- K131813Quidel Molecular RSV + HMPV AssayQuidel Corp. · 2013 · cites it directly7descendants
- K142045Xpert Flu/RSV XC AssayCepheid · 2014 · 2 generations on5descendants
- K101855Profast+ AssayGen-Probe Prodesse, Inc. · 2010 · 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) | K092500 | Modification to Proflu+ Assay | Prodesse, Inc. | 2009 | — |
| +1 | K110968 | Proflu+ Assay | Gen-Probe Prodesse, Inc. | 2011 | — |
| +2 | K132129 | Prodesse Proflu+ Assay | Gen-Probe Prodesse, Inc. | 2013 | — |
| +1 | K131813 | Quidel Molecular RSV + HMPV Assay | Quidel Corp. | 2013 | — |
| +2 | K142045 | Xpert Flu/RSV XC Assay | Cepheid | 2014 | — |
| +1 | K101855 | Profast+ Assay | Gen-Probe Prodesse, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 4 | 0 |
| 2013 | 6 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 4 | 0 |
| 2017 | 6 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2026 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K081030 | Modification to Proflu+ AssaySummary page 1…NAME OF DEVICE Trade Name: ProFlu+ Assay Regulation Number: 21 CFR 866.3980 Classification Name: Respiratory Viral Panel Multiplex Nucleic Acid Assay PREDICATE DEVICE K081030 - ProFtu+ Assay, Prodesse, Inc. K091667 - ID-Tag Respiratory Virus Panel, Luminex Molecular Diagnostics, Inc. INTENDED USE : The… | 2008 |
| * | K091667 | Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112, I019E0113, S019-0116Summary page 1…ay Regulation Number: 21 CFR 866.3980 Classification Name: Respiratory Viral Panel Multiplex Nucleic Acid Assay PREDICATE DEVICE K081030 - ProFtu+ Assay, Prodesse, Inc. K091667 - ID-Tag Respiratory Virus Panel, Luminex Molecular Diagnostics, Inc. INTENDED USE : The ProFlu+™ Assay is a multiplex Real Time… | 2009 |
What descends from it? (41)
See all 4110 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110968 | Proflu+ Assay | 2011 | 15 |
| K131813 | Quidel Molecular RSV + HMPV Assay | 2013 | 7 |
| K101855 | Profast+ Assay | 2010 | 5 |
| K153544 | cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System | 2016 | 4 |
| K120413 | Simplexa Flu a/B & RSV Direct, Simplexa Flu a/B & RSV Positive Control Pack | 2012 | 3 |
| K113777 | Quidel Molecular Influenza a+B | 2012 | 3 |
| K112172 | Quidel Molecular Influenza a + B Assay | 2011 | 3 |
| K131728 | Quidel Molecular Influenza a + B Assay | 2013 | 2 |
| K122189 | Quidel Molecular RSV + HMPV Assay | 2013 | 0 |
| K102170 | Simplexa Flu a/B & RSV | 2010 | 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 1 year and passes through 2 companies; a new generation was cleared every 6 months on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K110968 (Gen-Probe Prodesse, Inc., 2011) has gone furthest, with 15 descendants of its own.
- 7 other devices also cite its predicate K081030.
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. 2009, 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 ProFlu+™ Assay is a multiplex Real Time RT-PCR in vitro diagnostic test for the rapid and qualitative detection and discrimination of Influenza A Virus, Influenza B Virus, and Respiratory Syncytial Virus (RSV) nucleic acids isolated and purified from nasopharyngeal (NP) swab specimens obtained from symptomatic patients. This test is intended for use to aid in the differential diagnosis of Influenza A, Influenza B and RSV viral infections in humans…
Read the full statement (214 words)
The ProFlu+™ Assay is a multiplex Real Time RT-PCR in vitro diagnostic test for the rapid and qualitative detection and discrimination of Influenza A Virus, Influenza B Virus, and Respiratory Syncytial Virus (RSV) nucleic acids isolated and purified from nasopharyngeal (NP) swab specimens obtained from symptomatic patients. This test is intended for use to aid in the differential diagnosis of Influenza A, Influenza B and RSV viral infections in humans and is not intended to detect Influenza C.
Negative results do not preclude influenza or RSV virus infection and should not be used as the sole basis for treatment or other management decisions. It is recommended that negative RSV results be confirmed by culture.
Performance characteristics for Influenza A Virus were established when Influenza A/H3 and A/H1 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 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K092500 · printed Nov 3, 2026
Cite this page
510(k) Report. “K092500: Modification to Proflu+ Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K092500
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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