510(k) · Cleared
ClearedProfast+ 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 Jul 23, 2010 as substantially equivalent to DEN070013 (Luminex Molecular Diagnostics, Inc., 2008) and 7 other predicates after a 22-day review. Its family tree reaches back 4 generations to 2008. 5 later devices descend from it.
- Decided
- Jul 23, 2010
- Review
- 22 days
- Class
- Class II
- Product code
- OQW
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 4 generations to DEN070013 (2008). 9 ancestors in all, the oldest DEN060008 (2006). 5 later devices descend from it, 3 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 deviceK101855 Profast+ AssayGen-Probe Prodesse, Inc. · 2010
- Descendant · cites it directly · 2 of its ownK103209 Verigene Respiratory Virus Nucleic Acid Test +(Rvnat+)Nanosphere, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 0 of its ownK163628 Idylla Respiratory (IFV-RSV) PanelJanssen Pharmaceutica NV · 2017
- Descendant · cites it directly · 0 of its ownK132237 Prodesse Profast+ AssayGen-Probe Prodesse, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK131584 Imdx Flu a/B and RSV for Abbott M2000Intelligent Medical Devices, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK121003 Abbott Plex-ID Flu AssayAbbott Laboratories · 2012
Most influential descendants
Showing 5 of 5 · See all- K103209Verigene Respiratory Virus Nucleic Acid Test +(Rvnat+)Nanosphere, Inc. · 2011 · cites it directly2descendants
- K163628Idylla Respiratory (IFV-RSV) PanelJanssen Pharmaceutica NV · 2017 · 2 generations on0descendants
- K132237Prodesse Profast+ AssayGen-Probe Prodesse, Inc. · 2013 · cites it directly0descendants
- K131584Imdx Flu a/B and RSV for Abbott M2000Intelligent Medical Devices, Inc. · 2013 · 2 generations on0descendants
- K121003Abbott Plex-ID Flu AssayAbbott Laboratories · 2012 · cites it directly0descendants
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) | K101855 | Profast+ Assay | Gen-Probe Prodesse, Inc. | 2010 | — |
| +1 | K103209 | Verigene Respiratory Virus Nucleic Acid Test +(Rvnat+) | Nanosphere, Inc. | 2011 | 1 |
| +2 | K163628 | Idylla Respiratory (IFV-RSV) Panel | Janssen Pharmaceutica NV | 2017 | — |
| +1 | K132237 | Prodesse Profast+ Assay | Gen-Probe Prodesse, Inc. | 2013 | — |
| +2 | K131584 | Imdx Flu a/B and RSV for Abbott M2000 | Intelligent Medical Devices, Inc. | 2013 | — |
| +1 | K121003 | Abbott Plex-ID Flu Assay | Abbott Laboratories | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 3 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 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 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? (8)
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…say Regulation Number: 21 CFR 866.3980 Classification Name: Respiratory viral panel multiplex nucleic acid assay PREDICATE DEVICE • K063765, K081483, K091677 - ID Tag Respiratory Virus Panel, Lumninex Molecular Diagnostics * K080570 - Human Influenza Virus Real Time RT… | 2008 |
| * | K091667 | Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112, I019E0113, S019-0116 Our reading of the summary gave K091677, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “ID Tag Respiratory Virus Panel”. | 2009 |
| * | K080570 | CDC Human Influenza Virus Real-Time RT- PCR Detection and Characterization PanelSummary page 1…ry viral panel multiplex nucleic acid assay PREDICATE DEVICE • K063765, K081483, K091677 - ID Tag Respiratory Virus Panel, Lumninex Molecular Diagnostics * K080570 - Human Influenza Virus Real Time RT-PCR Detection and Characterization Panel, CDC • K100148 - Simplexa Influenza A HINI… | 2008 |
| * | K100148 | Simplexa Influenza a H1N1 (2009) Model MOL2500Summary page 1…Respiratory Virus Panel, Lumninex Molecular Diagnostics * K080570 - Human Influenza Virus Real Time RT-PCR Detection and Characterization Panel, CDC • K100148 - Simplexa Influenza A HINI (2009), Focus Diagnostics * K073029, K08 1030, K092500 - ProFlu+ Assay, Gen-Probe Prodesse, Inc.… | 2010 |
| * | K073029 | Proflu+ AssaySummary page 1…K080570 - Human Influenza Virus Real Time RT-PCR Detection and Characterization Panel, CDC • K100148 - Simplexa Influenza A HINI (2009), Focus Diagnostics * K073029, K08 1030, K092500 - ProFlu+ Assay, Gen-Probe Prodesse, Inc. INTENDED USE The ProFASTTm+ Assay is a multiplex Real Time RT-PC… | 2008 |
| * | K081030 | Modification to Proflu+ AssaySummary page 1…- Human Influenza Virus Real Time RT-PCR Detection and Characterization Panel, CDC • K100148 - Simplexa Influenza A HINI (2009), Focus Diagnostics * K073029, K08 1030, K092500 - ProFlu+ Assay, Gen-Probe Prodesse, Inc. INTENDED USE The ProFASTTm+ Assay is a multiplex Real Time RT-PCR in vitro… | 2008 |
| * | K092500 | Modification to Proflu+ AssaySummary page 1…fluenza Virus Real Time RT-PCR Detection and Characterization Panel, CDC • K100148 - Simplexa Influenza A HINI (2009), Focus Diagnostics * K073029, K08 1030, K092500 - ProFlu+ Assay, Gen-Probe Prodesse, Inc. INTENDED USE The ProFASTTm+ Assay is a multiplex Real Time RT-PCR in vitro diagnc~s… | 2009 |
What descends from it? (5)
3 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 2 years and passes through 3 companies; a new generation was cleared every 11 months on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K103209 (Nanosphere, Inc., 2011) has gone furthest, with 2 descendants of its own.
- 11 other devices also cite its predicate DEN070013.
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. 2010, 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 ProFASTTm+ Assay is a multiplex Real Time RT-PCR in vitro diagnostic test for the qualitative detection and discrimination of seasonal Influenza A/HI, seasonal Influenza A/H3 and 2009 H1N1 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…
Read the full statement (215 words)
The ProFASTTm+ Assay is a multiplex Real Time RT-PCR in vitro diagnostic test for the qualitative detection and discrimination of seasonal Influenza A/HI, seasonal Influenza A/H3 and 2009 H1N1 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 ilemagglutinin (HA) gene for seasonal Influenza A/HI, seasonal Influenza A/H-3 and 2009 H1N1 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/K101855 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101855: Profast+ Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101855
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