510(k) · Cleared
ClearedD3 Dfa Metapneumovirus Identification Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Hybrids, Inc. · OMG Antisera, Fluorescent, Human Metapneumovirus
Cleared on Mar 6, 2009 as substantially equivalent to K082688 (Prodesse, Inc., 2008) after a 53-day review. Its family tree reaches back 2 generations to 2008. 2 later devices descend from it.
- Decided
- Mar 6, 2009
- Review
- 53 days
- Class
- Class II
- Product code
- OMG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN070013 (2008). 2 later devices descend from it, 2 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 deviceK090073 D3 Dfa Metapneumovirus Identification KitDiagnostic Hybrids, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK093233 D3 Fastpoint L-Dfa RSV/MVP Identification KitDiagnostic Hybrids, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK091171 D3 Ultra Duet Dfa Respiratory Virus Identification KitDiagnostic Hybrids, Inc. · 2009
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) | K090073 | D3 Dfa Metapneumovirus Identification Kit | Diagnostic Hybrids, Inc. | 2009 | — |
| +1 | K093233 | D3 Fastpoint L-Dfa RSV/MVP Identification Kit | Diagnostic Hybrids, Inc. | 2009 | — |
| +1 | K091171 | D3 Ultra Duet Dfa Respiratory Virus Identification Kit | Diagnostic Hybrids, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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 OMG? 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? (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…lass II, Respiratory viral panel multiplex nucleic acid assay reagents; Panel Microbiology (83) Legally marketed device to which equivalence is claimed: K082688, Pro hMPV+ Assay Intended Use: The Pro hMPV+ Assay is a Real Time RT-PCR in vitro diagnostic test for the qualit… | 2008 |
What descends from it? (2)
2 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 1 year and passes through 3 companies; a new generation was cleared every 10 months on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K093233 (Diagnostic Hybrids, Inc., 2009) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K082688.
How does its category compare?
All OMG devicesOMG Antisera, Fluorescent, Human Metapneumovirus: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · OMG
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · OMG
53in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OMG
No recall names OMG since 2007.
Adverse event reports per year · OMG
No MAUDE report names OMG 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 | 3 | 53 | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 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 Diagnostic Hybrids, Inc. device, D 3 DFA Metapneumovirus Identification Kit, is intended for the qualitative detection and identification of human metapneumovirus (hMPV) in nasal and nasopharyngeal swabs and aspirates/washes or cell culture. The assay detects hMPV antigens by immunofluorescence using a blend of three monoclonal antibodies (MAbs), from patients with signs and symptoms of acute respiratory infection. This assay detects but is not…
Read the full statement (122 words)
The Diagnostic Hybrids, Inc. device, D 3 DFA Metapneumovirus Identification Kit, is intended for the qualitative detection and identification of human metapneumovirus (hMPV) in nasal and nasopharyngeal swabs and aspirates/washes or cell culture. The assay detects hMPV antigens by immunofluorescence using a blend of three monoclonal antibodies (MAbs), from patients with signs and symptoms of acute respiratory infection. This assay detects but is not intended to differentiate the four recognized 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. It is recommended that specimens found to be negative after examination of the direct specimen results be confirmed by an FDA cleared hMPV molecular assay.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090073 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090073: D3 Dfa Metapneumovirus Identification Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090073
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