510(k) · Cleared
ClearedProflu+ Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gen-Probe Prodesse, Inc. · OCC Respiratory Virus Panel Nucleic Acid Assay System
Cleared on Jun 27, 2011 as substantially equivalent to DEN070013 (Luminex Molecular Diagnostics, Inc., 2008) and 5 other predicates after an 82-day review. Its family tree reaches back 4 generations to 2008. 15 later devices descend from it.
- Decided
- Jun 27, 2011
- Review
- 82 days
- Class
- Class II
- Product code
- OCC
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 4 generations to DEN070013 (2008). 7 ancestors in all. 15 later devices descend from it, 4 citing it directly.
- Root · 4 generations backDEN070013 ID-Tag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008
- 3 generations backK081483 Xtag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008 · Recalled
- 2 generations backK091667 Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112…Luminex Molecular Diagnostics, Inc. · 2009 · Recalled
- 1 generation backK092500 Modification to Proflu+ AssayProdesse, Inc. · 2009
- This deviceK110968 Proflu+ AssayGen-Probe Prodesse, Inc. · 2011
- Descendant · cites it directly · 13 of its ownK132129 Prodesse Proflu+ AssayGen-Probe Prodesse, Inc. · 2013
- Descendant · cites it directly · 5 of its ownK142045 Xpert Flu/RSV XC AssayCepheid · 2014
- Descendant · cites it directly · 4 of its ownK153544 cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas…Iquum, Inc. · 2016
- Descendant · 2 generations on · 4 of its ownK151226 Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit…Cepheid · 2015
- Descendant · 2 generations on · 3 of its ownK200065 cobas Influenza A/B Nucleic acid test for use on the cobas Liat…Roche Molecular Systems, Inc. · 2020
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K132129Prodesse Proflu+ AssayGen-Probe Prodesse, Inc. · 2013 · cites it directly13descendants
- K142045Xpert Flu/RSV XC AssayCepheid · 2014 · cites it directly5descendants
- K153544cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat SystemIquum, Inc. · 2016 · cites it directly4descendants
- K151226Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress…Cepheid · 2015 · 2 generations on4descendants
- K200065cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas Influenza…Roche Molecular Systems, Inc. · 2020 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN070013 | ID-Tag Respiratory Viral Panel | Luminex Molecular Diagnostics, Inc. | 2008 | — |
| −3 | K081483 | Xtag Respiratory Viral Panel | Luminex Molecular Diagnostics, Inc. | 2008 | 1 |
| −2 | K091667 | Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112… | Luminex Molecular Diagnostics, Inc. | 2009 | 1 |
| −1 | K092500 | Modification to Proflu+ Assay | Prodesse, Inc. | 2009 | — |
| 0 (this device) | K110968 | Proflu+ Assay | Gen-Probe Prodesse, Inc. | 2011 | — |
| +1 | K132129 | Prodesse Proflu+ Assay | Gen-Probe Prodesse, Inc. | 2013 | — |
| +1 | K142045 | Xpert Flu/RSV XC Assay | Cepheid | 2014 | — |
| +1 | K153544 | cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System | Iquum, Inc. | 2016 | — |
| +2 | K151226 | Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert… | Cepheid | 2015 | — |
| +2 | K200065 | cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas… | Roche Molecular Systems, Inc. | 2020 | — |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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? (6)
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…TM Assay Regulation Number: 21 CER 866.3980 Classification Name: Respiratory viral panel multiplex nucleic acid assay PREDICATE DEVICE * K063765, K08 1483, K09 1677 -ID Tag Respiratory Virus Panel, Luminex Molecular Diagnostics * K073029, K08 1030, K092500 - ProFlu+ Assay, Gen… | 2008 |
| * | DEN110001 | Norovirus Serological Reagent Our reading of the summary gave K091677, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN110001, Norovirus Serological Reagent (), granted —; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | |
| * | K073029 | Proflu+ AssaySummary page 1…atory viral panel multiplex nucleic acid assay PREDICATE DEVICE * K063765, K08 1483, K09 1677 -ID Tag Respiratory Virus Panel, Luminex Molecular Diagnostics * K073029, K08 1030, K092500 - ProFlu+ Assay, Gen-Probe Prodesse, Inc. INTENDED USE The ProFluTM+ Assay is a multiplex Real-Time PCR (RT… | 2008 |
| * | K081030 | Modification to Proflu+ AssaySummary page 1…al panel multiplex nucleic acid assay PREDICATE DEVICE * K063765, K08 1483, K09 1677 -ID Tag Respiratory Virus Panel, Luminex Molecular Diagnostics * K073029, K08 1030, K092500 - ProFlu+ Assay, Gen-Probe Prodesse, Inc. INTENDED USE The ProFluTM+ Assay is a multiplex Real-Time PCR (RT-PCR) in v… | 2008 |
| * | K092500 | Modification to Proflu+ AssaySummary page 1…ultiplex nucleic acid assay PREDICATE DEVICE * K063765, K08 1483, K09 1677 -ID Tag Respiratory Virus Panel, Luminex Molecular Diagnostics * K073029, K08 1030, K092500 - ProFlu+ Assay, Gen-Probe Prodesse, Inc. INTENDED USE The ProFluTM+ Assay is a multiplex Real-Time PCR (RT-PCR) in vitro diag… | 2009 |
What descends from it? (15)
See all 154 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 3 companies; a new generation was cleared every 12 months on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K132129 (Gen-Probe Prodesse, Inc., 2013) has gone furthest, with 13 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 ProFluTM+ Assay is a multiplex Real-Time PCR (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…
Read the full statement (285 words)
The ProFluTM+ Assay is a multiplex Real-Time PCR (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. Conversely, 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 and clinical presentation must be considered in order to obtain the final diagnosis of respiratory viral infection.
Performance characteristics for Influenza A Virus were established when Influenza A/H and A/H I were the predominant Influenza A viruses in circulation (2006 - 2007 respiratory season). Performance characteristics for Influenza A were confirmed when Influenza AMHi, Influenza A/1-13, and Influenza A/2009 H IN I were the predominant Influenza A viruses in circulation (2008 and 2009). 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 as stated in the FDA summary.
https://510kreport.com/device/K110968 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110968: Proflu+ Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110968
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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