510(k) · Cleared
ClearedProParaFlu+ Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hologic, Inc. · OOU Parainfluenza Multiplex Nucleic Acid Assay
Cleared on Dec 9, 2015 as substantially equivalent to K132238 (Gen-Probe Prodesse, Inc., 2013) and 1 other predicate after a 33-day review. Its family tree reaches back 3 generations to 2008. 1 later device descends from it.
- Decided
- Dec 9, 2015
- Review
- 33 days
- Class
- Class II
- Product code
- OOU
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to DEN070013 (2008). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backDEN070013 ID-Tag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008
- 2 generations backK091053 Proparaflu+AssayProdesse, Inc. · 2009
- 1 generation backK132238 Proparaflu+ AssayGen-Probe Prodesse, Inc. · 2013
- This deviceK153223 ProParaFlu+ AssayHologic, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK172282 Panther Fusion Paraflu AssayHologic, Inc. · 2017
Most influential descendants
Showing 1 of 1 · See all- K172282Panther Fusion Paraflu AssayHologic, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN070013 | ID-Tag Respiratory Viral Panel | Luminex Molecular Diagnostics, Inc. | 2008 | — |
| −2 | K091053 | Proparaflu+Assay | Prodesse, Inc. | 2009 | — |
| −1 | K132238 | Proparaflu+ Assay | Gen-Probe Prodesse, Inc. | 2013 | — |
| 0 (this device) | K153223 | ProParaFlu+ Assay | Hologic, Inc. | 2015 | — |
| +1 | K172282 | Panther Fusion Paraflu Assay | Hologic, Inc. | 2017 | — |
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 OOU? 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? (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 |
|---|---|---|---|
| * | K132238 | Proparaflu+ AssaySummary page 4…gulation Number: 21 CFR 866.3980 Classification Name: Parainfluenza Multiplex Nucleic Acid Assay Product Code: OOU Predicate Devices K132238 – ProParaFlu®+ Assay, Hologic, Inc. K091053 – ProParaFlu®+ Assay, Prodesse Inc. Intended Use The Prodesse® ProParaflu®+ Assay i… | 2013 |
| * | K091053 | Proparaflu+AssaySummary page 4…Classification Name: Parainfluenza Multiplex Nucleic Acid Assay Product Code: OOU Predicate Devices K132238 – ProParaFlu®+ Assay, Hologic, Inc. K091053 – ProParaFlu®+ Assay, Prodesse Inc. Intended Use The Prodesse® ProParaflu®+ Assay is a multiplex Real-Time PCR (RT-PCR) in vitr… | 2009 |
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 |
|---|---|---|---|
| K172282 | Panther Fusion Paraflu Assay | 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 2.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K172282 (Hologic, Inc., 2017) has gone furthest, with 0 descendants of its own.
How does its category compare?
All OOU devicesOOU Parainfluenza Multiplex Nucleic Acid Assay: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · OOU
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · OOU
Too few OOU 510(k)s in any year since 2007 to give a median.
Recalls per year · OOU
No recall names OOU since 2007.
Adverse event reports per year · OOU
No MAUDE report names OOU since 2007.
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 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 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 Prodesse® ProParaflu®+ Assay is a multiplex Real-Time PCR (RT-PCR) in vitro diagnostic test for the qualitative detection and discrimination of Parainfluenza 1 Virus, Parainfluenza 2 Virus and Parainfluenza 3 Virus (HPIV-1, HPIV-2 and HPIV-3) nucleic acids isolated and purified from nasopharyngeal (NP) swab specimens obtained from individuals exhibiting signs and symptoms of respiratory tract infections. This Assay targets the conserved regions of…
Read the full statement (159 words)
The Prodesse® ProParaflu®+ Assay is a multiplex Real-Time PCR (RT-PCR) in vitro diagnostic test for the qualitative detection and discrimination of Parainfluenza 1 Virus, Parainfluenza 2 Virus and Parainfluenza 3 Virus (HPIV-1, HPIV-2 and HPIV-3) nucleic acids isolated and purified from nasopharyngeal (NP) swab specimens obtained from individuals exhibiting signs and symptoms of respiratory tract infections. This Assay targets the conserved regions of the Hemagglutinin-Neuraminidase (HN) gene of HPIV-1, HPIV-2 and HPIV-3, respectively. The detection and discrimination of HPIV-1, HPIV-2 and HPIV-3 nucleic acids from symptomatic patients aid in the diagnosis of human respiratory tract parainfluenza infections if used in conjunction with other clinical and laboratory findings. This test is not intended to detect Parainfluenza 4a or Parainfluenza 4b Viruses.
Negative test results are presumptive and should be confirmed by cell culture. Negative results do not preclude Parainfluenza 1, 2 or 3 virus infections and should not be used as the sole basis for treatment or other management decisions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153223 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153223: ProParaFlu+ Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153223
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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