510(k) · Cleared
ClearedLight Diagnostics Simulfluor HSV/VZV Immunoflourescence Assay, Model 3295
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Light Diagnostics · GQW Antigen, Cf, (Including Cf Control), Varicella-Zoster
Cleared on Oct 19, 1999 as substantially equivalent to K951799 (Light Diagnostics, 1996) after a 273-day review. Its family tree reaches back 1 generation to 1996. 1 later device descends from it.
- Decided
- Oct 19, 1999
- Review
- 273 days
- Class
- Class II
- Product code
- GQW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K951799 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK951799 Varicella-Zoster Virus Direct Immunofluorescence AssayLight Diagnostics · 1996
- This deviceK990141 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 1 of 1 · See all- K070206Diagnostic Hybrids D3 Dfa Varicella-Zoster Virus Identification Kit, 01-020000Diagnostic Hybrids, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K951799 | Varicella-Zoster Virus Direct Immunofluorescence Assay | Light Diagnostics | 1996 | — |
| 0 (this device) | 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 |
|---|---|---|
| 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 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? (4)
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 3…against VZV used in the Light Diagnostics SimulFluor™ HSV/VZV reagent are identical to those used in the Light Diagnostics VZV DFA, cleared for in vitro diagnostic use (K951799). The monoclonal antibodies directed against HSV used in the Light Diagnostics SimulFluor™ HSV/VZV reagent were characterized fo… | 1996 |
| * | — | Bartels HSV Fluorescent Monoclonal Antibody Test Named without a submission number | |
| * | — | Meridian Merifluor™ VZV Named without a submission number | |
| * | — | DPC PathoDx® Herpes Typing Kit Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070206 | Diagnostic Hybrids D3 Dfa Varicella-Zoster Virus Identification Kit, 01-020000 | 2007 | 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?
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.
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?
Light Diagnostics SimulFluor™ HSV/VZV immunofluorescence Assay is a direct immunofluorescence test intended for the simultaneous detection and identification of HSV 1 and 2 and varicella-zoster virus (VZV) from patients with vesicular, oral, genital, or skin lesions, and following amplification of virus in culture. Specimens found to be negative on direct specimen examination should be tested by cell culture.
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/K990141 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990141: Light Diagnostics Simulfluor HSV/VZV Immunoflourescence Assay, Model 3295.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990141
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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