510(k) · Cleared
ClearedPro HMPV+ Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prodesse, Inc. · OEM Human Metapneumovirus (Hmpv) Rna Assay System
Cleared on Nov 7, 2008 as substantially equivalent to DEN070013 (Luminex Molecular Diagnostics, Inc., 2008) after a 53-day review. Its family tree reaches back 1 generation to 2008. 15 later devices descend from it.
- Decided
- Nov 7, 2008
- Review
- 53 days
- Class
- Class II
- Product code
- OEM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN070013 (2008). 15 later devices descend from it, 5 citing it directly.
- Root · 1 generation backDEN070013 ID-Tag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008
- This deviceK082688 Pro HMPV+ AssayProdesse, Inc. · 2008
- Descendant · cites it directly · 7 of its ownK131813 Quidel Molecular RSV + HMPV AssayQuidel Corp. · 2013
- Descendant · 2 generations on · 4 of its ownK161375 Alere i RSV, Alere i Instrument, Alere i RSV Control Swab KitAlere Scarborough, Inc. · 2016 · Recalled
- Descendant · 3 generations on · 3 of its ownK173932 Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i…Alere Scarborough, Inc. · 2018
- Descendant · cites it directly · 2 of its ownK112490 Quidel Molecular HMPV AssayQuidel Corp. · 2011
- Descendant · cites it directly · 2 of its ownK090073 D3 Dfa Metapneumovirus Identification KitDiagnostic Hybrids, Inc. · 2009
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K131813Quidel Molecular RSV + HMPV AssayQuidel Corp. · 2013 · cites it directly7descendants
- K161375Alere i RSV, Alere i Instrument, Alere i RSV Control Swab KitAlere Scarborough, Inc. · 2016 · 2 generations on4descendants
- K173932Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2Alere Scarborough, Inc. · 2018 · 3 generations on3descendants
- K112490Quidel Molecular HMPV AssayQuidel Corp. · 2011 · cites it directly2descendants
- K090073D3 Dfa Metapneumovirus Identification KitDiagnostic Hybrids, Inc. · 2009 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN070013 | ID-Tag Respiratory Viral Panel | Luminex Molecular Diagnostics, Inc. | 2008 | — |
| 0 (this device) | K082688 | Pro HMPV+ Assay | Prodesse, Inc. | 2008 | — |
| +1 | K131813 | Quidel Molecular RSV + HMPV Assay | Quidel Corp. | 2013 | — |
| +2 | K161375 | Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit | Alere Scarborough, Inc. | 2016 | 2 |
| +3 | K173932 | Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2 | Alere Scarborough, Inc. | 2018 | — |
| +1 | K112490 | Quidel Molecular HMPV Assay | Quidel Corp. | 2011 | — |
| +1 | K090073 | D3 Dfa Metapneumovirus Identification Kit | Diagnostic Hybrids, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 3 | 0 |
| 2011 | 1 | 0 |
| 2013 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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 OEM? 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 OEM device
- #1 K230349 Lyra RSV+hMPV Assayscore 6.2 · 5 generations · no Class I recall
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 |
|---|---|---|---|
| * | 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 |
What descends from it? (15)
See all 155 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?
How does its category compare?
All OEM devicesOEM Human Metapneumovirus (Hmpv) Rna 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 · OEM
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · OEM
34in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OEM
No recall names OEM since 2007.
Adverse event reports per year · OEM
1in 2023
MAUDE reports naming product code OEM, 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 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 3 | 34 | 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 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Pro hMPV+ Assay is a Real Time RT-PCR in vitro diagnostic test for the qualitative detection of human Metapneumovirus (hMPV) nucleic acid isolated and purified from nasopharyngeal swab (NP) specimens obtained from individuals exhibiting signs and symptoms of acute respiratory infection. This assay targets a highly conserved region of the Nucleocapsid gene of hMPV. The detection of hMPV nucleic acid from symptomatic patients aids in the diagnosis of…
Read the full statement (119 words)
The Pro hMPV+ Assay is a Real Time RT-PCR in vitro diagnostic test for the qualitative detection of human Metapneumovirus (hMPV) nucleic acid isolated and purified from nasopharyngeal swab (NP) specimens obtained from individuals exhibiting signs and symptoms of acute respiratory infection. This assay targets a highly conserved region of the Nucleocapsid gene of hMPV. The detection of hMPV nucleic acid from symptomatic patients aids in the diagnosis of human respiratory hMPV infection if used in conjunction with other clinical and laboratory findings. This test is not intended to differentiate the four genetic sub-lineages of hMPV.
Negative results do not preclude hMPV infection and should not be used as the sole basis for diagnosis, treatment or other management decisions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082688 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082688: Pro HMPV+ Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082688
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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