510(k) · Cleared

Cleared

D3 Ultra Dfa Respiratory Virus Screening & ID Kit

K061101510(k) TraditionalCleared Nov 20, 2006214-day reviewClass I21 CFR 866.3330

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Diagnostic Hybrids, Inc. · GNW Antisera, Cf, Influenza Virus A, B, C

Cleared on Nov 20, 2006 as substantially equivalent to K022713 (Diagnostic Hybrids, Inc., 2002) after a 214-day review. Its family tree reaches back 1 generation to 2002. 7 later devices descend from it.

Decided: Nov 20, 2006
Review: 214 days
Class: Class I
Product code: GNW
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K022713 (2002). 7 later devices descend from it, 7 citing it directly.

By dateBy generation

Root · 1 generation backK022713 Dfa Respiratory Virus Screening & ID KitDiagnostic Hybrids, Inc. · 2002
This deviceK061101 D3 Ultra Dfa Respiratory Virus Screening & ID KitDiagnostic Hybrids, Inc. · 2006
Descendant · cites it directly · 4 of its ownK081928 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

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2008high 5 (2009) · low 0 (2010)2026

Most influential descendants

Showing 5 of 7 · See all

K081928D3 Duet Dfa RSV/Respiratory Virus Screening KitDiagnostic Hybrids, Inc. · 2008 · cites it directly4descendants
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
−1	K022713	Dfa Respiratory Virus Screening & ID Kit	Diagnostic Hybrids, Inc.	2002	—
0 (this device)	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	—
+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
2008	2	0
2009	5	0

FIG. 1 — Lineage of K061101, 2002–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K022713	Dfa Respiratory Virus Screening & ID Kit Summary page 3 …azide. J. Substantial Equivalence Information: 1. Predicate device name(s): DFA Respiratory Virus Screening & ID Kit 2. Predicate 5 10(k) number(s): K022713 3. Comparison with predicate: The similarities to predicate device are in indicated use, operating principle, basic…	Diagnostic Hybrids, Inc.	2002	—

What descends from it? (7)

7 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K081928	D3 Duet Dfa RSV/Respiratory Virus Screening Kit	Diagnostic Hybrids, Inc.	2008	4
K093415	D3 Fastpoint L-Dfa Parainfluenza Virus/Adenovirus Identification Kit	Diagnostic Hybrids, Inc.	2009	0
K093233	D3 Fastpoint L-Dfa RSV/MVP Identification Kit	Diagnostic Hybrids, Inc.	2009	0
K092882	D3 Fastpoint L-Dfa Influenza a/Influenza B Virus Identification Kit	Diagnostic Hybrids, Inc.	2009	0
K091171	D3 Ultra Duet Dfa Respiratory Virus Identification Kit	Diagnostic Hybrids, Inc.	2009	0
K092300	Modification to D3 Ultra Dfa Respiratory Virus Screening & ID Kit	Diagnostic Hybrids, Inc.	2009	0
K081746	D3 Duet Dfa Influenza a/Respiratory Virus Screening Kit	Diagnostic Hybrids, Inc.	2008	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?

Its one ancestor has no recall.
Of its descendants, K081928 (Diagnostic Hybrids, Inc., 2008) has gone furthest, with 4 descendants of its own.

How does its category compare?

All GNW devices

GNW 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

2007high 2 (2009) · low 0 (2007)2026

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

2007high 2 (2008) · low 0 (2007)2026

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.'s 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 (107 words)

The Diagnostic Hybrids, Inc.'s 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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K061101 · printed Nov 4, 2026

Cite this page

510(k) Report. “K061101: 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/K061101

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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