510(k) · Cleared
ClearedPro HMPV+ Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gen-Probe Prodesse, Inc. · OEM Human Metapneumovirus (Hmpv) Rna Assay System
Cleared on Jan 16, 2013 as substantially equivalent to K082688 (Prodesse, Inc., 2008) and 3 other predicates after a 34-day review. Its family tree reaches back 3 generations to 2008. 1 later device descends from it.
- Decided
- Jan 16, 2013
- Review
- 34 days
- Class
- Class II
- Product code
- OEM
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to DEN070013 (2008). 5 ancestors in all. 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 backK081483 Xtag Respiratory Viral PanelLuminex Molecular Diagnostics, Inc. · 2008 · Recalled
- 1 generation backK091667 Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112…Luminex Molecular Diagnostics, Inc. · 2009 · Recalled
- This deviceK123838 Pro HMPV+ AssayGen-Probe Prodesse, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK132200 Pro HMPV+ AssayGen-Probe Prodesse, Inc. · 2013
Most influential descendants
Showing 1 of 1 · See all- K132200Pro HMPV+ AssayGen-Probe Prodesse, Inc. · 2013 · 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 | K081483 | Xtag Respiratory Viral Panel | Luminex Molecular Diagnostics, Inc. | 2008 | 1 |
| −1 | K091667 | Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112… | Luminex Molecular Diagnostics, Inc. | 2009 | 1 |
| 0 (this device) | K123838 | Pro HMPV+ Assay | Gen-Probe Prodesse, Inc. | 2013 | — |
| +1 | K132200 | Pro HMPV+ Assay | Gen-Probe Prodesse, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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? (5)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K082688 | Pro HMPV+ AssaySummary page 1…gulation Number: 21 CER 866.3980 Product Code: OEM Classification Name: Nucleic acid amplification assay for human metapneumovirus RNA PREDICATE DEVICE * K082688, Gen-Probe Prodesse Pro hMPV+ Assay * KI 12490, Quidel Molecular hMPV Assay * K063765, K08 1483, K091667 Luminex ID-Tag RVP A… | 2008 |
| * | K112490 | Quidel Molecular HMPV Assay | 2011 |
| Kept off the family tree | K063765 | Luminex RVP Assay Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…c acid amplification assay for human metapneumovirus RNA PREDICATE DEVICE * K082688, Gen-Probe Prodesse Pro hMPV+ Assay * KI 12490, Quidel Molecular hMPV Assay * K063765, K08 1483, K091667 Luminex ID-Tag RVP Assay INTENDED USE The Pro hMPVTM+ Assay is a Real-Time PCR (RT-PCR) in vitro diagnostic… | |
| * | K081483 | Xtag Respiratory Viral PanelSummary page 1…plification assay for human metapneumovirus RNA PREDICATE DEVICE * K082688, Gen-Probe Prodesse Pro hMPV+ Assay * KI 12490, Quidel Molecular hMPV Assay * K063765, K08 1483, K091667 Luminex ID-Tag RVP Assay INTENDED USE The Pro hMPVTM+ Assay is a Real-Time PCR (RT-PCR) in vitro diagnostic test for t… | 2008 |
| * | K091667 | Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112, I019E0113, S019-0116Summary page 1…n assay for human metapneumovirus RNA PREDICATE DEVICE * K082688, Gen-Probe Prodesse Pro hMPV+ Assay * KI 12490, Quidel Molecular hMPV Assay * K063765, K08 1483, K091667 Luminex ID-Tag RVP Assay INTENDED USE The Pro hMPVTM+ Assay is a Real-Time PCR (RT-PCR) in vitro diagnostic test for the qualit… | 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 |
|---|---|---|---|
| K132200 | Pro HMPV+ Assay | 2013 | 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 5 years and passes through 2 companies; a new generation was cleared every 12 months on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K132200 (Gen-Probe Prodesse, Inc., 2013) has gone furthest, with 0 descendants 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. 2013, 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 Prodesse Pro hMPV+ Assay is a Real-Time PCR (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…
Read the full statement (120 words)
The Prodesse Pro hMPV+ Assay is a Real-Time PCR (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/K123838 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123838: 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/K123838
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