510(k) · Cleared
ClearedProflu+ 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 Jan 4, 2008 after a 67-day review. The FDA summary names its predicate without a number. 85 later devices descend from it.
- Decided
- Jan 4, 2008
- Review
- 67 days
- Class
- Class II
- Product code
- OCC
- Recalls
- None
- Predicates
- 0
85 later devices descend from it, 10 citing it directly.
- This deviceK073029 Proflu+ AssayProdesse, Inc. · 2008
- Descendant · cites it directly · 59 of its ownK080570 CDC Human Influenza Virus Real-Time RT- PCR Detection and…Centers for Disease Control and Prevention · 2008
- Descendant · cites it directly · 45 of its ownK081030 Modification to Proflu+ AssayProdesse, Inc. · 2008
- Descendant · 2 generations on · 41 of its ownK092500 Modification to Proflu+ AssayProdesse, Inc. · 2009
- Descendant · 2 generations on · 34 of its ownK100148 Simplexa Influenza a H1N1 (2009) Model MOL2500Focus Diagnostics, Inc. · 2010
- Descendant · cites it directly · 27 of its ownK103766 Xpert Flu, Genexpert DX Systems, Genexpert Infinity System…Cepheid · 2011 · Recalled
Showing 5 of 85 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 85 · See all- K080570CDC Human Influenza Virus Real-Time RT- PCR Detection and Characterization PanelCenters for Disease Control and Prevention · 2008 · cites it directly59descendants
- K081030Modification to Proflu+ AssayProdesse, Inc. · 2008 · cites it directly45descendants
- K092500Modification to Proflu+ AssayProdesse, Inc. · 2009 · 2 generations on41descendants
- K100148Simplexa Influenza a H1N1 (2009) Model MOL2500Focus Diagnostics, Inc. · 2010 · 2 generations on34descendants
- K103766Xpert Flu, Genexpert DX Systems, Genexpert Infinity System, Genexpert System Software…Cepheid · 2011 · cites it directly27descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K073029 | Proflu+ Assay | Prodesse, Inc. | 2008 | — |
| +1 | K080570 | CDC Human Influenza Virus Real-Time RT- PCR Detection and Characterization Panel | Centers for Disease Control and Prevention | 2008 | — |
| +1 | K081030 | Modification to Proflu+ Assay | Prodesse, Inc. | 2008 | — |
| +2 | K092500 | Modification to Proflu+ Assay | Prodesse, Inc. | 2009 | — |
| +2 | K100148 | Simplexa Influenza a H1N1 (2009) Model MOL2500 | Focus Diagnostics, Inc. | 2010 | — |
| +1 | K103766 | Xpert Flu, Genexpert DX Systems, Genexpert Infinity System, Genexpert System… | Cepheid | 2011 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2009 | 4 | 0 |
| 2010 | 5 | 0 |
| 2011 | 8 | 0 |
| 2012 | 7 | 0 |
| 2013 | 9 | 0 |
| 2014 | 7 | 0 |
| 2015 | 7 | 0 |
| 2016 | 6 | 0 |
| 2017 | 8 | 0 |
| 2018 | 4 | 0 |
| 2019 | 4 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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? (1)
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 |
|---|---|---|---|
| * | — | xTAG Respiratory Viral Panel Luminex Molecular Diagnostics Named without a submission number |
What descends from it? (85)
See all 8510 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080570 | CDC Human Influenza Virus Real-Time RT- PCR Detection and Characterization Panel | 2008 | 59 |
| K081030 | Modification to Proflu+ Assay | 2008 | 45 |
| K103766 | Xpert Flu, Genexpert DX Systems, Genexpert Infinity System, Genexpert System Software… | 2011 | 27 |
| K110968 | Proflu+ Assay | 2011 | 15 |
| K101855 | Profast+ Assay | 2010 | 5 |
| K083088 | Verigene Respiratory Virus Nucleic Acid Test | 2009 | 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 |
| K121003 | Abbott Plex-ID Flu Assay | 2012 | 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?
- Of its descendants, K080570 (Centers for Disease Control and Prevention, 2008) has gone furthest, with 59 descendants of its own.
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. 2008, 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+TM 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 (219 words)
The ProFlu+TM 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.
A negative test is presumptive and it is recommended these results be confirmed by cell culture. 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.
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 A viruses are emerging, performance characteristics may vary.
If infections with a novel Influenza A virus are 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/K073029 · printed Nov 5, 2026
Cite this page
510(k) Report. “K073029: Proflu+ Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K073029
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