510(k) · Cleared
ClearedLight Diagnostics HSV 1/2 Typing Dfa Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Millipore Corporation · GQL Antisera, Fluorescent, Herpesvirus Hominis 1,2
Cleared on Apr 1, 2009 after a 303-day review. The FDA summary names its predicate without a number.
- Decided
- Apr 1, 2009
- Review
- 303 days
- Class
- Class II
- Product code
- GQL
- 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 GQL? 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 |
|---|---|---|---|
| * | — | Cell Culture 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 GQL devicesGQL Antisera, Fluorescent, Herpesvirus Hominis 1,2: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · GQL
2in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · GQL
Too few GQL 510(k)s in any year since 2007 to give a median.
Recalls per year · GQL
No recall names GQL since 2007.
Adverse event reports per year · GQL
1in 2009
MAUDE reports naming product code GQL, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 1 |
| 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 Light Diagnostics TM HSV 1/2 Typing DFA Kit is an in vitro diagnostic test for the qualitative detection and identification of herpes simplex virus type I and/or type 2 in direct specimens from patients with vesicular lesions and symptoms consistent with herpes infection and for culture confirmation by immunofluorescence. Negative results do not preclude an infection and should not be used as the sole basis for diagnosis, treatment or other management decisions. Specimens found negative on direct specimen detection should be confirmed by 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/K081527 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081527: Light Diagnostics HSV 1/2 Typing Dfa Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081527
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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