510(k) · Cleared
ClearedModification to D3 Ultra Dfa Respiratory Virus Screening & ID 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 Aug 28, 2009 as substantially equivalent to K061101 (Diagnostic Hybrids, Inc., 2006) after a 30-day review. Its family tree reaches back 2 generations to 2002.
- Decided
- Aug 28, 2009
- Review
- 30 days
- Class
- Class I
- Product code
- GNW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K022713 (2002). No later device cites it as a predicate yet.
- 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 deviceK092300 Modification to D3 Ultra Dfa Respiratory Virus Screening & ID KitDiagnostic Hybrids, Inc. · 2009
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) | K092300 | Modification to D3 Ultra Dfa Respiratory Virus Screening & ID 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? (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….3330, Class I, Influenza virus serological reagents, Panel Microbiology (83) LEGALLY MARKETED DEVICE D 3 Ultra DFA Respiratory Virus Screening & ID Kit, K06 1101 DESCRIPTION of DEVICE MODIFICATION The product insert has been modified. The following has been added (see below):… | 2006 |
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 3.9 years on median.
- None of the 2 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. D 3 Ultra DFA (direct fluorescent antibody) Respiratory Virus Screening & ID Kit is intended for the qualitative detection and identification of the Influenza A, Influenza B, Respiratory Syncytial Virus (RSV), Adenovirus, Parainfluenza 1, Parainfluenza 2 and Parainfluenza 3 virus in respiratory specimens, by either direct detection or cell culture method, by immunofluorescence using fluoresceinated monoclonal antibodies…
Read the full statement (206 words)
The Diagnostic Hybrids, Inc. D 3 Ultra DFA (direct fluorescent antibody) Respiratory Virus Screening & ID Kit is intended for the qualitative detection and identification of the Influenza A, Influenza B, Respiratory Syncytial Virus (RSV), Adenovirus, Parainfluenza 1, Parainfluenza 2 and Parainfluenza 3 virus in respiratory specimens, by either direct detection or cell culture method, by immunofluorescence using fluoresceinated monoclonal antibodies (MAbs). 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 respiratory virus infection and should not be used as the sole basis for diagnosis, treatment or other management decisions.
Performance characteristics for influenza A were established when influenza A/H3 and A/HI were the predominant influenza A viruses in circulation. 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 state or local health departments for testing. Viral culture should not be attempted in these cases unless a BSL3+ facility' is available to receive and culture specimens. 2
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K092300 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092300: Modification to D3 Ultra Dfa Respiratory Virus Screening & ID Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092300
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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