510(k) · Cleared
ClearedProFlu+ Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hologic, Inc. · OCC Respiratory Virus Panel Nucleic Acid Assay System
Cleared on Nov 20, 2015 as substantially equivalent to K081030 (Prodesse, Inc., 2008) and 1 other predicate after a 15-day review. Its family tree reaches back 6 generations to 2008. 1 later device descends from it.
- Decided
- Nov 20, 2015
- Review
- 15 days
- Class
- Class II
- Product code
- OCC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to DEN070013 (2008). 9 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backDEN070013 ID-Tag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008
- 5 generations backK081483 Xtag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008 · Recalled
- 4 generations backK091667 Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112…Luminex Molecular Diagnostics, Inc. · 2009 · Recalled
- 3 generations backK092500 Modification to Proflu+ AssayProdesse, Inc. · 2009
- 2 generations backK110968 Proflu+ AssayGen-Probe Prodesse, Inc. · 2011
- 1 generation backK132129 Prodesse Proflu+ AssayGen-Probe Prodesse, Inc. · 2013
- This deviceK153219 ProFlu+ AssayHologic, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK171963 Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids…Hologic, Inc. · 2017 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K171963Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther Fusion…Hologic, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | DEN070013 | ID-Tag Respiratory Viral Panel | Luminex Molecular Diagnostics, Inc. | 2008 | — |
| −5 | K081483 | Xtag Respiratory Viral Panel | Luminex Molecular Diagnostics, Inc. | 2008 | 1 |
| −4 | K091667 | Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112… | Luminex Molecular Diagnostics, Inc. | 2009 | 1 |
| −3 | K092500 | Modification to Proflu+ Assay | Prodesse, Inc. | 2009 | — |
| −2 | K110968 | Proflu+ Assay | Gen-Probe Prodesse, Inc. | 2011 | — |
| −1 | K132129 | Prodesse Proflu+ Assay | Gen-Probe Prodesse, Inc. | 2013 | — |
| 0 (this device) | K153219 | ProFlu+ Assay | Hologic, Inc. | 2015 | — |
| +1 | K171963 | Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther… | Hologic, Inc. | 2017 | 1 |
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 |
|---|---|---|
| 2017 | 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? (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 4…er: 21 CFR 866.3980 Classification Name: Respiratory Virus Panel Multiplex Nucleic Acid Assay Product Code: OCC Predicate Devices K081030 – ProFluTM+ Assay, Hologic, Inc. K132129 – ProFlu+ Assay, Gen-Probe Prodesse, Inc. Intended Use The Prodesse® ProFluTM+ Assay i… | 2008 |
| * | K132129 | Prodesse Proflu+ AssaySummary page 4…ation Name: Respiratory Virus Panel Multiplex Nucleic Acid Assay Product Code: OCC Predicate Devices K081030 – ProFluTM+ Assay, Hologic, Inc. K132129 – ProFlu+ Assay, Gen-Probe Prodesse, Inc. Intended Use The Prodesse® ProFluTM+ Assay is a multiplex Real-Time PCR (RT-PCR) in v… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171963 | Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther Fusion… | 2017 | 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 7 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K171963 (Hologic, Inc., 2017) has gone furthest, with 0 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. 2015, 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 Prodesse® 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…
Read the full statement (284 words)
The Prodesse® 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/H3 and A/H1 were the predominant
Influenza A viruses in circulation (2006 – 2007 respiratory season). Performance characteristics for Influenza A were
confirmed when Influenza A/H1, Influenza A/H3, and Influenza A/2009 H1N1 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/K153219 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153219: 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/K153219
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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