510(k) · Cleared
ClearedD3 Duet Dfa RSV/Respiratory Virus Screening Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Hybrids, Inc. · LKT Respiratory Syncytial Virus, Antigen, Antibody, Ifa
Cleared on Dec 23, 2008 as substantially equivalent to K061101 (Diagnostic Hybrids, Inc., 2006) after a 169-day review. Its family tree reaches back 2 generations to 2002. 4 later devices descend from it.
- Decided
- Dec 23, 2008
- Review
- 169 days
- Class
- Class I
- Product code
- LKT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K022713 (2002). 4 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK022713 Dfa Respiratory Virus Screening & ID KitDiagnostic Hybrids, Inc. · 2002
- 1 generation backK061101 D3 Ultra Dfa Respiratory Virus Screening & ID KitDiagnostic Hybrids, Inc. · 2006
- This deviceK081928 D3 Duet Dfa RSV/Respiratory Virus Screening KitDiagnostic Hybrids, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK093415 D3 Fastpoint L-Dfa Parainfluenza Virus/Adenovirus 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 ownK092882 D3 Fastpoint L-Dfa Influenza a/Influenza B Virus 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 4 of 4 · See all- K093415D3 Fastpoint L-Dfa Parainfluenza Virus/Adenovirus Identification KitDiagnostic Hybrids, Inc. · 2009 · cites it directly0descendants
- K093233D3 Fastpoint L-Dfa RSV/MVP Identification KitDiagnostic Hybrids, Inc. · 2009 · cites it directly0descendants
- K092882D3 Fastpoint L-Dfa Influenza a/Influenza B Virus Identification KitDiagnostic Hybrids, Inc. · 2009 · cites it directly0descendants
- K091171D3 Ultra Duet Dfa Respiratory Virus Identification KitDiagnostic Hybrids, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K022713 | Dfa Respiratory Virus Screening & ID Kit | Diagnostic Hybrids, Inc. | 2002 | — |
| −1 | K061101 | D3 Ultra Dfa Respiratory Virus Screening & ID Kit | Diagnostic Hybrids, Inc. | 2006 | — |
| 0 (this device) | K081928 | D3 Duet Dfa RSV/Respiratory Virus Screening Kit | Diagnostic Hybrids, Inc. | 2008 | — |
| +1 | K093415 | D3 Fastpoint L-Dfa Parainfluenza Virus/Adenovirus Identification Kit | Diagnostic Hybrids, Inc. | 2009 | — |
| +1 | K093233 | D3 Fastpoint L-Dfa RSV/MVP Identification Kit | Diagnostic Hybrids, Inc. | 2009 | — |
| +1 | K092882 | D3 Fastpoint L-Dfa Influenza a/Influenza B Virus 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 | 4 | 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 LKT? 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 |
|---|---|---|---|
| * | K061101 | D3 Ultra Dfa Respiratory Virus Screening & ID KitSummary page 1…866.3480, Class I, respiratory syncytial virus serological reagents; Panel Microbiology (83) Legally marketed device to which equivalence is claimed: K061101, D 3 Ultra DFA Respiratory Virus Screening & ID Kit Intended Use: The Diagnostic Hybrids, Inc. device, D 3 Duet DFA RSV… | 2006 |
What descends from it? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093415 | D3 Fastpoint L-Dfa Parainfluenza Virus/Adenovirus Identification Kit | 2009 | 0 |
| K093233 | D3 Fastpoint L-Dfa RSV/MVP Identification Kit | 2009 | 0 |
| K092882 | D3 Fastpoint L-Dfa Influenza a/Influenza B Virus Identification Kit | 2009 | 0 |
| K091171 | D3 Ultra Duet Dfa Respiratory Virus Identification Kit | 2009 | 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 6 years and passes through 1 company; a new generation was cleared every 3.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K093415 (Diagnostic Hybrids, Inc., 2009) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K061101.
How does its category compare?
All LKT devicesLKT Respiratory Syncytial Virus, Antigen, Antibody, Ifa: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · LKT
1in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · LKT
Too few LKT 510(k)s in any year since 2007 to give a median.
Recalls per year · LKT
No recall names LKT since 2007.
Adverse event reports per year · LKT
No MAUDE report names LKT 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 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 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 Duet DFA RSV/Respiratory Virus Screening Kit, is intended for the qualitative detection and identification of respiratory syncytial virus, while screening for influenza A virus, influenza B virus, adenovirus, and parainfluenza virus types 1, 2 and 3 viral antigens, in nasal and nasopharyngeal swabs and aspirates or in cell culture. The assay detects viral antigens by immunofluorescence using monoclonal antibodies…
Read the full statement (262 words)
The Diagnostic Hybrids, Inc. device, D3 Duet DFA RSV/Respiratory Virus Screening Kit, is intended for the qualitative detection and identification of respiratory syncytial virus, while screening for influenza A virus, influenza B virus, adenovirus, and parainfluenza virus types 1, 2 and 3 viral antigens, in nasal and nasopharyngeal swabs and aspirates or in cell culture. The assay detects viral antigens by immunofluorescence using monoclonal antibodies (MAbs), from patients with signs and symptoms of respiratory infection.
It is recommended that specimens found to be negative after examination of the direct specimen result be confirmed by cell culture. Negative results do not preclude influenza 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 (HINI) were the predominant influenza A strains circulating in the United States. Performance characteristics for influenza A virus detection and identification were established when influenza A H3N2 and influenza A HI N 1 were the predominant influenza A strains circulating in the United States. When other Influenza A viruses are emerging, performance characteristics may vary. If infection with a novel Influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to a state or local health department 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/K081928 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081928: D3 Duet Dfa RSV/Respiratory Virus Screening Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081928
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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