510(k) · Cleared
ClearedThe Aptus (Automated) Application of the HSV-1 Igg Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) for
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zeus Scientific, Inc. · GQL Antisera, Fluorescent, Herpesvirus Hominis 1,2
Cleared on May 26, 1999 after a 189-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- May 26, 1999
- Review
- 189 days
- Class
- Class II
- Product code
- GQL
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
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?
This test system is designed for the manual or automated, qualitative detection of IgG antibodies to HSV-1 in human serum. The test system is intended to be used to evaluate serologic evidence of primary or reactivated infection with HSV. Due to cross reactivity of shared antigens, the HSV-2 IgG ELISA test should be performed in conjunction with this test system to fully evaluate the patient serum. The test is for in vitro diagnostic use.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K984135 · printed Nov 4, 2026
Cite this page
510(k) Report. “K984135: The Aptus (Automated) Application of the HSV-1 Igg Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) for.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984135
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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