510(k) · Cleared
ClearedProdesse Profast+ Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gen-Probe Prodesse, Inc. · OQW 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification
Cleared on Aug 26, 2013 as substantially equivalent to K101855 (Gen-Probe Prodesse, Inc., 2010) after a 39-day review. Its family tree reaches back 5 generations to 2008.
- Decided
- Aug 26, 2013
- Review
- 39 days
- Class
- Class II
- Product code
- OQW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to DEN070013 (2008). 10 ancestors in all, the oldest DEN060008 (2006). No later device cites it as a predicate yet.
- Root · 5 generations backDEN070013 ID-Tag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008
- 4 generations backK081483 Xtag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008 · Recalled
- 3 generations backK091667 Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112…Luminex Molecular Diagnostics, Inc. · 2009 · Recalled
- 2 generations backK092500 Modification to Proflu+ AssayProdesse, Inc. · 2009
- 1 generation backK101855 Profast+ AssayGen-Probe Prodesse, Inc. · 2010
- This deviceK132237 Prodesse Profast+ AssayGen-Probe Prodesse, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | DEN070013 | ID-Tag Respiratory Viral Panel | Luminex Molecular Diagnostics, Inc. | 2008 | — |
| −4 | K081483 | Xtag Respiratory Viral Panel | Luminex Molecular Diagnostics, Inc. | 2008 | 1 |
| −3 | K091667 | Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112… | Luminex Molecular Diagnostics, Inc. | 2009 | 1 |
| −2 | K092500 | Modification to Proflu+ Assay | Prodesse, Inc. | 2009 | — |
| −1 | K101855 | Profast+ Assay | Gen-Probe Prodesse, Inc. | 2010 | — |
| 0 (this device) | K132237 | Prodesse Profast+ Assay | Gen-Probe Prodesse, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 3 | 0 |
| 2010 | 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 OQW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K101855 | Profast+ AssaySummary page 1…of Influenza A Virus Subtypes: A/seasonal HI1, A/seasonal H3, and A/2009 HLNi Influenza Virus PREDICATE DEVICE K101855, ProFAST TM± Assay INTENDED USE The Prodesse® ProFAST®+ Assay is a multiplex Real Time RT-PCR in vitro diagnostic test for the q… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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 5 years and passes through 3 companies; a new generation was cleared every 11 months on median.
- 2 of the 10 ancestors have a recall of any class.
- 2 other devices also cite its predicate K101855.
How does its category compare?
All OQW devicesOQW 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · OQW
3in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · OQW
39in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OQW
No recall names OQW since 2007.
Adverse event reports per year · OQW
1in 2011
MAUDE reports naming product code OQW, 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 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 3 | 22 | 0 | 0 |
| 2011 | 3 | 83 | 0 | 1 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 3 | 39 | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ProdesseJProFASr®O+ Assay is a multiplex Real Time RT-PCR in vitro diagnostic test for the qualitative detection and discrimination of seasonal Influenza A/HI1, seasonal Influenza AIH3 and 2009 H IN I Influenza viral nucleic acids isolated and purified from nasopharyngeal (NP) swab specimens from human patients with signs and symptoms of respiratory infection in conjunction with clinical and epidemiological risk factors. This Assay targets conserved…
Read the full statement (218 words)
The ProdesseJProFASr®O+ Assay is a multiplex Real Time RT-PCR in vitro diagnostic test for the qualitative detection and discrimination of seasonal Influenza A/HI1, seasonal Influenza AIH3 and 2009 H IN I Influenza viral nucleic acids isolated and purified from nasopharyngeal (NP) swab specimens from human patients with signs and symptoms of respiratory infection in conjunction with clinical and epidemiological risk factors. This Assay targets conserved regions of the Hemagglutinin (HA) gene for seasonal Influenza A/I-l, seasonal Influenza A/H3 and 2009 HINI Influenza Virus, respectively. This Assay is not intended to detect Influenza B or Influenza C Viruses.
A negative ProFAST+ Assay result is a presumptive negative result for Influenza A. These results should be confirmed by an FDA cleared nucleic acid-based test (NAT) detecting Influenza A.
Negative results do not preclude Influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions.
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/K132237 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132237: Prodesse Profast+ Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132237
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