510(k) · Cleared
ClearedQuidel Molecular HMPV Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quidel Corp. · OEM Human Metapneumovirus (Hmpv) Rna Assay System
Cleared on Dec 15, 2011 as substantially equivalent to K082688 (Prodesse, Inc., 2008) after a 108-day review. Its family tree reaches back 2 generations to 2008. 2 later devices descend from it.
- Decided
- Dec 15, 2011
- Review
- 108 days
- Class
- Class II
- Product code
- OEM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN070013 (2008). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backDEN070013 ID-Tag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008
- 1 generation backK082688 Pro HMPV+ AssayProdesse, Inc. · 2008
- This deviceK112490 Quidel Molecular HMPV AssayQuidel Corp. · 2011
- Descendant · cites it directly · 1 of its ownK123838 Pro HMPV+ AssayGen-Probe Prodesse, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK132200 Pro HMPV+ AssayGen-Probe Prodesse, Inc. · 2013
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN070013 | ID-Tag Respiratory Viral Panel | Luminex Molecular Diagnostics, Inc. | 2008 | — |
| −1 | K082688 | Pro HMPV+ Assay | Prodesse, Inc. | 2008 | — |
| 0 (this device) | K112490 | Quidel Molecular HMPV Assay | Quidel Corp. | 2011 | — |
| +1 | K123838 | Pro HMPV+ Assay | Gen-Probe Prodesse, Inc. | 2013 | — |
| +2 | K132200 | Pro HMPV+ Assay | Gen-Probe Prodesse, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 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 |
|---|---|---|---|
| * | K082688 | Pro HMPV+ AssaySummary page 1…eic acid assay Product Code - OEM Regulation -21 CFR 866.3980 Legally marketed devices to which equivalence is claimed: Gen-Probe Prodesse Pro bMPV+ (k082688) The Pro hMPV+ Assay is a Real Time RT-PCR in vitro diagnostic test for the qualitative detection of human Metapneumo… | 2008 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123838 | Pro HMPV+ Assay | 2013 | 1 |
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 3 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K123838 (Gen-Probe Prodesse, Inc., 2013) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K082688.
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. 2011, 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 Quidel Molecular hMPV assay is a multiplex Real Time RT-PCR assay for the in vitro qualitative detection of human metapneumnovirus RNA in nasal and nasopharyngeal swab specimens from patients with signs and symptomjs of respiratory infection. This test is intended for use as an aid in the differential diagnosis of human mnetapneumnovirus infections in humans in conjunction with clinical and epidemiological risk factors. 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 patient management decisions.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K112490 · printed Nov 3, 2026
Cite this page
510(k) Report. “K112490: Quidel Molecular HMPV Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K112490
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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