510(k) · Cleared
ClearedD3 Fastpoint L-Dfa RSV/MVP 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 Dec 4, 2009 as substantially equivalent to K061101 (Diagnostic Hybrids, Inc., 2006) and 2 other predicates after a 51-day review. Its family tree reaches back 3 generations to 2002.
- Decided
- Dec 4, 2009
- Review
- 51 days
- Class
- Class II
- Product code
- OMG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K022713 (2002). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK022713 Dfa Respiratory Virus Screening & ID KitDiagnostic Hybrids, Inc. · 2002
- 2 generations backK061101 D3 Ultra Dfa Respiratory Virus Screening & ID KitDiagnostic Hybrids, Inc. · 2006
- 1 generation backK081928 D3 Duet Dfa RSV/Respiratory Virus Screening KitDiagnostic Hybrids, Inc. · 2008
- This deviceK093233 D3 Fastpoint L-Dfa RSV/MVP Identification KitDiagnostic Hybrids, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K022713 | Dfa Respiratory Virus Screening & ID Kit | Diagnostic Hybrids, Inc. | 2002 | — |
| −2 | K061101 | D3 Ultra Dfa Respiratory Virus Screening & ID Kit | Diagnostic Hybrids, Inc. | 2006 | — |
| −1 | K081928 | D3 Duet Dfa RSV/Respiratory Virus Screening Kit | Diagnostic Hybrids, Inc. | 2008 | — |
| 0 (this device) | K093233 | D3 Fastpoint L-Dfa RSV/MVP Identification Kit | Diagnostic Hybrids, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2009 | 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 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? (3)
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 |
|---|---|---|---|
| * | K061101 | D3 Ultra Dfa Respiratory Virus Screening & ID KitSummary page 5…D' Ultra Kit D3 Duet RSV Kit D9 MPV Kit Characteristics Identification Kit 510(k) #k061 101 510(k) II k081928 510(k) II k090073 ___ ___ ___ ____ ___… | 2006 |
| * | K081928 | D3 Duet Dfa RSV/Respiratory Virus Screening KitSummary page 2…ttempted in these cases unless a BSL3-I facility is available to receive and culture specimens. D3 Duet DFA RSVlRespiratory Virus Screening Kit (k081928) Intended Use: The Diagnostic Hybrids, Inc. device, D3 Duet DEA RSV/Respiratory Virus Screening Kit (D3… | 2008 |
| * | K090073 | D3 Dfa Metapneumovirus Identification KitSummary page 3…not be attempted in these cases unless a BSL3+ facility is available to receive and culture specimens. D 3 DFA Metapneumovirus Identifi cation Kit (k090073) Intended Use: The Diagnostic Hybrids, Inc. device, D3 DFA Metapneumnovirus Identification Kit (D 3 MP… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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 1 company; a new generation was cleared every 2.1 years on median.
- None of the 6 ancestors has a recall.
- 6 other devices also cite its predicate K061101.
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, D3 FastPoint L-DFA RSV/MPV Identification Kit is intended for the qualitative identification of respiratory syncytial virus and human metapneumovirus in nasal and nasopharyngeal swabs and aspirates/washes specimens from patients with signs and symptoms of respiratory infection by direct detection of immunofluorescence using monoclonal antibodies (MAbs). It is recommended that specimens found to be negative for…
Read the full statement (128 words)
The Diagnostic Hybrids, Inc. device, D3 FastPoint L-DFA RSV/MPV Identification Kit is intended for the qualitative identification of respiratory syncytial virus and human metapneumovirus in nasal and nasopharyngeal swabs and aspirates/washes specimens from patients with signs and symptoms of respiratory infection by direct detection of immunofluorescence using monoclonal antibodies (MAbs).
It is recommended that specimens found to be negative for respiratory syncytial virus after examination of the direct specimen result be confirmed by cell culture. Specimens found to be negative for human metapneumovirus after examination of the direct specimen results should be confirmed by an FDA-cleared human metapneurnovirus molecular assay. Negative results do not preclude respiratory syncytial virus and human metapneumovirus 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/K093233 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093233: D3 Fastpoint L-Dfa RSV/MVP 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/K093233
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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