510(k) · Cleared
ClearedVaricella-Zoster Virus Direct Immunofluorescence Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Light Diagnostics · GQX Antiserum, Cf, Varicella-Zoster
Cleared on Mar 20, 1996 after a 336-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- Mar 20, 1996
- Review
- 336 days
- Class
- Class II
- Product code
- GQX
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK951799 Varicella-Zoster Virus Direct Immunofluorescence AssayLight Diagnostics · 1996
- Descendant · cites it directly · 1 of its ownK990141 Light Diagnostics Simulfluor HSV/VZV Immunoflourescence Assay, Model…Light Diagnostics · 1999
- Descendant · cites it directly · 0 of its ownK070206 Diagnostic Hybrids D3 Dfa Varicella-Zoster Virus Identification Kit…Diagnostic Hybrids, Inc. · 2007
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K951799 | Varicella-Zoster Virus Direct Immunofluorescence Assay | Light Diagnostics | 1996 | — |
| +1 | K990141 | Light Diagnostics Simulfluor HSV/VZV Immunoflourescence Assay, Model 3295 | Light Diagnostics | 1999 | — |
| +1 | K070206 | Diagnostic Hybrids D3 Dfa Varicella-Zoster Virus Identification Kit, 01-020000 | Diagnostic Hybrids, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2007 | 1 | 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 GQX? 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? (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 | Decided |
|---|---|---|---|
| * | — | Meridian Diagnostics, Inc. Merifluor VZV Named without a submission number |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K990141 (Light Diagnostics, 1999) has gone furthest, with 1 descendant of its own.
How does its category compare?
All GQX devicesGQX Antiserum, Cf, Varicella-Zoster: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GQX
FDA has decided no GQX device since 2007.
Median 510(k) review, days · GQX
Too few GQX 510(k)s in any year since 2007 to give a median.
Recalls per year · GQX
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GQX
No MAUDE report names GQX 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 | — | 1 | 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?
Light Diagnostics Varicella-zoster virus Direct Immunofluorescence Assay is intended for in vitro diagnostic use in the qualitative detection of VZV from vesicular smears and in cell culture viral isolation and confirmation.
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/K951799 · printed Nov 4, 2026
Cite this page
510(k) Report. “K951799: Varicella-Zoster Virus Direct Immunofluorescence Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K951799
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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