510(k) · Cleared
ClearedDiagnostic Hybrids D3 Dfa Varicella-Zoster Virus Identification Kit, 01-020000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Hybrids, Inc. · GQW Antigen, Cf, (Including Cf Control), Varicella-Zoster
Cleared on Aug 30, 2007 as substantially equivalent to K951799 (Light Diagnostics, 1996) and 1 other predicate after a 220-day review. Its family tree reaches back 2 generations to 1996.
- Decided
- Aug 30, 2007
- Review
- 220 days
- Class
- Class II
- Product code
- GQW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K951799 (1996). No later device cites it as a predicate yet.
- Root · 2 generations backK951799 Varicella-Zoster Virus Direct Immunofluorescence AssayLight Diagnostics · 1996
- 1 generation backK990141 Light Diagnostics Simulfluor HSV/VZV Immunoflourescence Assay, Model…Light Diagnostics · 1999
- This deviceK070206 Diagnostic Hybrids D3 Dfa Varicella-Zoster 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 |
|---|---|---|---|---|---|
| −2 | K951799 | Varicella-Zoster Virus Direct Immunofluorescence Assay | Light Diagnostics | 1996 | — |
| −1 | K990141 | Light Diagnostics Simulfluor HSV/VZV Immunoflourescence Assay, Model 3295 | Light Diagnostics | 1999 | — |
| 0 (this device) | K070206 | Diagnostic Hybrids D3 Dfa Varicella-Zoster Virus Identification Kit, 01-020000 | Diagnostic Hybrids, Inc. | 2007 | — |
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 GQW? 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 |
|---|---|---|---|
| * | K951799 | Varicella-Zoster Virus Direct Immunofluorescence AssaySummary page 2…Assay (DFA) 2. Light Diagnostics Simulfluor HSV/VZV Immunofluorescence Assay Predicate 510(k) number(s): 1. K951799 2. K990141 3. Comparison with Predicate: The similarities to predicate devices are in indicated use,… | 1996 |
| * | K990141 | Light Diagnostics Simulfluor HSV/VZV Immunoflourescence Assay, Model 3295Summary page 2…FA) 2. Light Diagnostics Simulfluor HSV/VZV Immunofluorescence Assay Predicate 510(k) number(s): 1. K951799 2. K990141 3. Comparison with Predicate: The similarities to predicate devices are in indicated use, operating principle,… | 1999 |
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 11 years and passes through 2 companies; a new generation was cleared every 7.9 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K951799.
How does its category compare?
All GQW devicesGQW Antigen, Cf, (Including Cf Control), Varicella-Zoster: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · GQW
1in 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · GQW
Too few GQW 510(k)s in any year since 2007 to give a median.
Recalls per year · GQW
No recall names GQW since 2007.
Adverse event reports per year · GQW
1in 2017
MAUDE reports naming product code GQW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 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 | 1 |
| 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 D3 DFA Varicella-zoster Virus Identification Kit is intended for use in the qualitative detection of varicella-zoster virus (VZV) 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 decision.
Performance testing has not been done on direct patient specimen testing.
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/K070206 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070206: Diagnostic Hybrids D3 Dfa Varicella-Zoster Virus Identification Kit, 01-020000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070206
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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