510(k) · Cleared
ClearedD3 Ultra Duet Dfa Respiratory Virus 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 Sep 11, 2009 as substantially equivalent to K061101 (Diagnostic Hybrids, Inc., 2006) and 2 other predicates after a 142-day review. Its family tree reaches back 3 generations to 2002.
- Decided
- Sep 11, 2009
- Review
- 142 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 deviceK091171 D3 Ultra Duet Dfa Respiratory Virus 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) | K091171 | D3 Ultra Duet Dfa Respiratory Virus 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 1…Panel Microbiology (83) Legally marketed devices to which equivalence is claimed: D 3 Ultra DFA Respiratory Virus Screening & ID Kit (k061101) Intended Use: The Diagnostic Hybrids, Inc. D3 Ultra DFA (direct fluorescent a… | 2006 |
| * | K081928 | D3 Duet Dfa RSV/Respiratory Virus Screening KitSummary page 2…tempted in these cases unless a BSL3+ facility is available to receive and culture specimens. D3 Duet DFA RSV/Respiratory Virus Screening Kit (k081928) The Diagnostic Hybrids, Inc. device, D3 Duet DFA RSV/Respiratory Virus Screening Kit (D 3 D… | 2008 |
| * | K090073 | D3 Dfa Metapneumovirus Identification KitSummary page 3…attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. D3 DFA Metapneumovirus Identification Kit (k090073) The Diagnostic Hybrids, Inc. device, D3 DFA Metapneumovirus Identification Kit (D 3 MPV Kit… | 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 Respiratory Virus Identification Kit is intended for the qualitative identification of influenza A virus, influenza B virus, respiratory syncytial virus, human metapneumovirus, adenovirus and to screen for the presence of parainfluenza virus types 1, 2, and 3 in nasal and nasopharyngeal swabs and aspirates/washes specimens from, patients with signs and symptoms of respiratory infection by direct…
Read the full statement (262 words)
The Diagnostic Hybrids, Inc. device, D3 FastPoint L-DFA Respiratory Virus Identification Kit is intended for the qualitative identification of influenza A virus, influenza B virus, respiratory syncytial virus, human metapneumovirus, adenovirus and to screen for the presence of parainfluenza virus types 1, 2, and 3 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 influenza A virus, influenza B virus, respiratory syncytial virus, adenovirus or parainfluenza viruses 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 metapneumovirus molecular assay. Negative results do not preclude respiratory virus infection and should not be used as the sole basis for diagnosis, treatment or other management decisions.
Performance characteristics for influenza A virus detection and identification were established when influenza A (H3N2) and influenza A (H1N1) were the predominant influenza A strains circulating in the United States. Since influenza strains display antigenic drift and shift from year to year, performance characteristics may vary. If infection with a novel influenza A virus is suspected, based on clinical and epidemiological screening criteria communicated by public health authorities, collect specimens following appropriate infection control precautions and submit to state or local health departments, for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility' is available to receive and culture specimens.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091171 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091171: D3 Ultra Duet Dfa Respiratory Virus Identification Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091171
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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