510(k) · Cleared
ClearedZeus Scientific, Inc VZV Igm Elisa Test System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zeus Scientific, Inc. · LFY Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster
Cleared on Jul 5, 2007 after a 153-day review. The FDA summary names its predicate without a number.
- Decided
- Jul 5, 2007
- Review
- 153 days
- Class
- Class II
- Product code
- LFY
- 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 LFY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LFY device
- #1 K231214 LIAISON VZV IgG HT, LIAISON Control VZV IgG HTscore 6.8 · 3 generations · no Class I recall
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 |
|---|---|---|---|
| * | — | Captia VZV IgM ELISA Test 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 LFY devicesLFY Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · LFY
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · LFY
Too few LFY 510(k)s in any year since 2007 to give a median.
Recalls per year · LFY
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LFY
2in 2024
MAUDE reports naming product code LFY, 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 | 2 | — | 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 | 1 | — | 0 | 20 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 1 | 2 |
| 2023 | 1 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Zeus Scientific Varicella Zoster Virus (VZV) IgM ELISA Test System is
intended for the qualitative detection of IgM class antibodies to Varicella Zoster
Virus in human serum as an aid in the diagnosis of primary infection or
reactivation.
The assay performance in detecting antibodies to VZV in individuals vaccinated
with the FDA licensed VZV vaccine is unknown.
The user of this assay is responsible for establishing the performance
characteristics with VZV vaccinated individuals.
The assay performance in detecting antibodies to VZV in cord blood and
neonates has not been established.
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/K070317 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070317: Zeus Scientific, Inc VZV Igm Elisa Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070317
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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