510(k) · Cleared
ClearedDiagnostic Hybrids' D3 Dfa Herpes Simplex Virus Identification Kit, Model 01-080000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Hybrids, Inc. · GQN Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2
Cleared on Sep 21, 2007 as substantially equivalent to K902662 (Baxter Healthcare Corp, 1990) and 2 other predicates after a 273-day review. Its family tree reaches back 1 generation to 1988.
- Decided
- Sep 21, 2007
- Review
- 273 days
- Class
- Class II
- Product code
- GQN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K880157 (1988). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK880157 Microtrak HSV 1/HSV 2 Culture Identi./Typing TestSyva Co. · 1988
- This deviceK063798 Diagnostic Hybrids' D3 Dfa Herpes Simplex Virus Identification Kit…Diagnostic Hybrids, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K880157 | Microtrak HSV 1/HSV 2 Culture Identi./Typing Test | Syva Co. | 1988 | — |
| 0 (this device) | K063798 | Diagnostic Hybrids' D3 Dfa Herpes Simplex Virus Identification Kit, Model… | Diagnostic Hybrids, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 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 GQN? 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? (3)
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 |
|---|---|---|---|
| * | K902662 | Bartels Herpes Simplex Vir Flu Mono Antibody TestSummary page 1…, HERPESVIRUS HOMINIS 1,2 (21 CFR 866.3305, product code GQL) Legally marketed devices to which equivalence is K902662 Bartels" Herpes Simplex Virus Fluorescent Monoclonal Antibody Test claimed: K90… | 1990 |
| * | K904167 | Pathodx Herpes TypingSummary page 1…to which equivalence is K902662 Bartels" Herpes Simplex Virus Fluorescent Monoclonal Antibody Test claimed: K904167 Pathodx® Herpes Typing Kit K880157 MicroTrak® HSV 1/HSV 2 Culture Identification… | 1990 |
| * | K880157 | Microtrak HSV 1/HSV 2 Culture Identi./Typing TestSummary page 1…Fluorescent Monoclonal Antibody Test claimed: K904167 Pathodx® Herpes Typing Kit K880157 MicroTrak® HSV 1/HSV 2 Culture Identification and Typing Test Device Description The Diagnostic Hy… | 1988 |
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?
- None of the 3 ancestors has a recall.
How does its category compare?
All GQN devicesGQN Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · GQN
2in 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · GQN
Too few GQN 510(k)s in any year since 2007 to give a median.
Recalls per year · GQN
No recall names GQN since 2007.
Adverse event reports per year · GQN
No MAUDE report names GQN since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 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 D 3 DFA Herpes Simplex Virus Identification Kit is intended for use in the qualitative detection of human herpes simplex virus (HSV) in cell cultures by immunofluorescence using fluoresceinated monoclonal antibodies (MAbs).
Negative results do not preclude an infection and should not be used as the sole basis for diagnosis, treatment or other management decisions.
Performance using direct specimen testing has not been evaluated.
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/K063798 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063798: Diagnostic Hybrids' D3 Dfa Herpes Simplex Virus Identification Kit, Model 01-080000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063798
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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