510(k) · Cleared
ClearedD3 Fastpoint L-Dfa Influenza a/Influenza B Virus Identification Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Hybrids, Inc. · GNW Antisera, Cf, Influenza Virus A, B, C
Cleared on Oct 21, 2009 as substantially equivalent to K061101 (Diagnostic Hybrids, Inc., 2006) and 1 other predicate after a 33-day review. Its family tree reaches back 3 generations to 2002.
- Decided
- Oct 21, 2009
- Review
- 33 days
- Class
- Class I
- Product code
- GNW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K022713 (2002). 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 deviceK092882 D3 Fastpoint L-Dfa Influenza a/Influenza B 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) | K092882 | D3 Fastpoint L-Dfa Influenza a/Influenza B Virus Identification Kit | Diagnostic Hybrids, Inc. | 2009 | — |
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 GNW? 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? (2)
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…gical reagents; 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 antibody) Respiratory Virus Scree… | 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. D 3 Duet DFA RSV/Respiratory Virus Screening Kit (k081928) Intended Use: The Diagnostic Hybrids, Inc. device, D 3 Duet DFA RSV/Respiratory Virus Screening Kit (D 3 Duet… | 2008 |
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 3 ancestors has a recall.
- 6 other devices also cite its predicate K061101.
How does its category compare?
All GNW devicesGNW Antisera, Cf, Influenza Virus A, B, C: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · GNW
2in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · GNW
Too few GNW 510(k)s in any year since 2007 to give a median.
Recalls per year · GNW
2in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GNW
No MAUDE report names GNW 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 | — | 2 | 0 |
| 2009 | 2 | — | 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, D 3 FastPoint L-DFA Influenza A/Influenza B Virus Identification Kit is intended for the qualitative identification of influenza A virus and influenza B virus 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…
Read the full statement (219 words)
The Diagnostic Hybrids, Inc. device, D 3 FastPoint L-DFA Influenza A/Influenza B Virus Identification Kit is intended for the qualitative identification of influenza A virus and influenza B virus 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 or influenza B virus after examination of the direct specimen result be confirmed by cell culture. Negative results do not preclude influenza A or influenza B 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 (HI N I) 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/K092882 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092882: D3 Fastpoint L-Dfa Influenza a/Influenza B Virus Identification Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092882
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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