510(k) · Cleared
ClearedD3 Fastpoint L-Dfa Parainfluenza Virus/Adenovirus Identification Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Hybrids, Inc. · GQS Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4
Cleared on Dec 23, 2009 as substantially equivalent to K061101 (Diagnostic Hybrids, Inc., 2006) and 1 other predicate after a 51-day review. Its family tree reaches back 3 generations to 2002.
- Decided
- Dec 23, 2009
- Review
- 51 days
- Class
- Class I
- Product code
- GQS
- 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 deviceK093415 D3 Fastpoint L-Dfa Parainfluenza Virus/Adenovirus 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) | K093415 | D3 Fastpoint L-Dfa Parainfluenza Virus/Adenovirus 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 GQS? 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…lass - Class I Panel Microbiology (83) Legally marketed devices to which equivalence, is claimed: D'3 Ultra DFA Respiratory Virus Screening & ID Kit (k061 101) Intended Use: The Diagnostic Hybrids, Inc. D 3 Ultra DFA (direct fluorescent antibody) Respiratory Vi… | 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. D3 Duet DFA RSVlRespiratory Virus Screening Kit (k081928) Intended Use: The Diagnostic Hybrids, Inc. device, D3 Duet DFA RSV/Respiratory Virus Screening Kit (D… | 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 GQS devicesGQS Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · GQS
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · GQS
Too few GQS 510(k)s in any year since 2007 to give a median.
Recalls per year · GQS
No recall names GQS since 2007.
Adverse event reports per year · GQS
No MAUDE report names GQS 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 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 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 H-ybrids, Inc. device, D 3 FastPoint L-DFA Parainfluenza Virus/Adenovirus Identification Kit is intended for the qualitative identification of adenovirus and to screen for the presence of parainfluenza virus types 1, 2, and 3 in nasal and nasopharyngeal swabs and aspirates/washes specimens from patients with signs and symptoms of respiratory infection by direct detection of inmmuofluorescence using monoclonal antibodies (MAbs). It is…
Read the full statement (113 words)
The Diagnostic H-ybrids, Inc. device, D 3 FastPoint L-DFA Parainfluenza Virus/Adenovirus Identification Kit is intended for the qualitative identification of
adenovirus and to screen for the presence of parainfluenza virus types 1, 2, and 3 in nasal
and nasopharyngeal swabs and aspirates/washes specimens from patients with signs and
symptoms of respiratory infection by direct detection of inmmuofluorescence using
monoclonal antibodies (MAbs).
It is recommended that specimens found to be negative for parainfluenza virus and
adenovirus after examination of the direct specimen result be confirmed by cell culture.
Negative results do not preclude parainfluenza virus and adenovirus 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/K093415 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093415: D3 Fastpoint L-Dfa Parainfluenza Virus/Adenovirus 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/K093415
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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