510(k) · Cleared
ClearedDfa 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 Dec 18, 2002 after a 126-day review. The FDA summary names its predicate without a number. 8 later devices descend from it.
- Decided
- Dec 18, 2002
- Review
- 126 days
- Class
- Class I
- Product code
- GNW
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 1 citing it directly.
- This deviceK022713 Dfa Respiratory Virus Screening & ID KitDiagnostic Hybrids, Inc. · 2002
- Descendant · cites it directly · 7 of its ownK061101 D3 Ultra Dfa Respiratory Virus Screening & ID KitDiagnostic Hybrids, Inc. · 2006
- Descendant · 2 generations on · 4 of its ownK081928 D3 Duet Dfa RSV/Respiratory Virus Screening KitDiagnostic Hybrids, Inc. · 2008
- Descendant · 2 generations on · 0 of its ownK093415 D3 Fastpoint L-Dfa Parainfluenza Virus/Adenovirus Identification KitDiagnostic Hybrids, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK093233 D3 Fastpoint L-Dfa RSV/MVP Identification KitDiagnostic Hybrids, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK092882 D3 Fastpoint L-Dfa Influenza a/Influenza B Virus Identification KitDiagnostic Hybrids, Inc. · 2009
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K061101D3 Ultra Dfa Respiratory Virus Screening & ID KitDiagnostic Hybrids, Inc. · 2006 · cites it directly7descendants
- K081928D3 Duet Dfa RSV/Respiratory Virus Screening KitDiagnostic Hybrids, Inc. · 2008 · 2 generations on4descendants
- K093415D3 Fastpoint L-Dfa Parainfluenza Virus/Adenovirus Identification KitDiagnostic Hybrids, Inc. · 2009 · 2 generations on0descendants
- K093233D3 Fastpoint L-Dfa RSV/MVP Identification KitDiagnostic Hybrids, Inc. · 2009 · 2 generations on0descendants
- K092882D3 Fastpoint L-Dfa Influenza a/Influenza B Virus Identification KitDiagnostic Hybrids, Inc. · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 | — |
| +2 | K081928 | D3 Duet Dfa RSV/Respiratory Virus Screening Kit | Diagnostic Hybrids, Inc. | 2008 | — |
| +2 | K093415 | D3 Fastpoint L-Dfa Parainfluenza Virus/Adenovirus Identification Kit | Diagnostic Hybrids, Inc. | 2009 | — |
| +2 | K093233 | D3 Fastpoint L-Dfa RSV/MVP Identification Kit | Diagnostic Hybrids, Inc. | 2009 | — |
| +2 | K092882 | D3 Fastpoint L-Dfa Influenza a/Influenza B Virus Identification Kit | Diagnostic Hybrids, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 5 | 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 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 |
|---|---|---|---|
| * | — | Bartels Viral Respiratory Screening and Identification Kit Named without a submission number | |
| * | — | Diagnostic Hybrids, Inc. IFA Respiratory Viruses Screening and Identification Kit Named without a submission number |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061101 | D3 Ultra Dfa Respiratory Virus Screening & ID Kit | 2006 | 7 |
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?
- Of its descendants, K061101 (Diagnostic Hybrids, Inc., 2006) has gone furthest, with 7 descendants of its own.
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.
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. DFA (Direct Fluorescent Antibody) Respiratory Virus Screening & ID Kit is intended for the qualitative detection and identification of the common respiratory viruses, Influenza A, Influenza B, Respiratory Syncytial Virus (RSV), Adenovirus, Parainfluenza 1, Parainfluenza 2 and Parainfluenza 3 in direct specimens and cell cultures. It is recommended that specimens found to be negative after examination of the direct specimen result be confirmed by cell culture.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022713 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022713: Dfa Respiratory Virus Screening & ID Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022713
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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