510(k) · Cleared
ClearedLight Diagnostics Simulfluor HSV 1/2 Immunofluorecence Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Light Diagnostics · GQN Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2
Cleared on Nov 9, 1999 after a 160-day review. The FDA summary names its predicate without a number.
- Decided
- Nov 9, 1999
- Review
- 160 days
- Class
- Class II
- Product code
- GQN
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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? (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 |
|---|---|---|---|
| * | — | Bartels Herpes Simplex Virus Type-Specific Fluorescent Monoclonal Antibody Test (HSV… Named without a submission number | |
| * | — | DPC PathoDx® Herpes Typing Kit Named without a submission number |
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.
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.
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?
Light Diagnostics SimulFluor™ HSV1/2 Immunofluorescence Assay is a direct immunofluorescence test intended for the detection and identification of herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2) following amplification in cell culture or by direct examination of clinical specimens prepared by cytospin. Specimens found to be negative on direct specimen examination should be tested by cell culture.
For in vitro diagnostic use.
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/K991880 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991880: Light Diagnostics Simulfluor HSV 1/2 Immunofluorecence Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991880
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026