510(k) · Cleared
ClearedZeus Elisa Borrelia Vlse-1/PEPC10 Igg/Igm Test System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zeus Scientific, Inc. · LSR Reagent, Borrelia Serological Reagent
Cleared on Jul 26, 2012 after a 252-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Jul 26, 2012
- Review
- 252 days
- Class
- Class II
- Product code
- LSR
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK113397 Zeus Elisa Borrelia Vlse-1/PEPC10 Igg/Igm Test SystemZeus Scientific, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK193051 LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus…DiaSorin, Inc. · 2020
Most influential descendants
Showing 1 of 1 · See all- K193051LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control SetDiaSorin, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K113397 | Zeus Elisa Borrelia Vlse-1/PEPC10 Igg/Igm Test System | Zeus Scientific, Inc. | 2012 | — |
| +1 | K193051 | LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set | DiaSorin, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
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 LSR? 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 LSR device
- #1 K254295 Sofia Lyme FIA; Sofia 2 Campylobacter FIAscore 12.6 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K193051 | LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set | 2020 | 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?
- Of its descendants, K193051 (DiaSorin, Inc., 2020) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LSR devicesLSR Reagent, Borrelia Serological Reagent: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · LSR
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LSR
133in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LSR
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LSR
1in 2025
MAUDE reports naming product code LSR, 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 | 2 | — | 0 | 2 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 3 | 155 | 0 | 0 |
| 2013 | 2 | — | 1 | 0 |
| 2014 | 0 | — | 0 | 53 |
| 2015 | 1 | — | 0 | 25 |
| 2016 | 1 | — | 0 | 10 |
| 2017 | 6 | 150 | 0 | 9 |
| 2018 | 3 | 92 | 0 | 4 |
| 2019 | 4 | 86 | 0 | 15 |
| 2020 | 3 | 91 | 0 | 7 |
| 2021 | 6 | 133 | 2 | 4 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 2 | — | 1 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The ZEUS ELISA Borrelia VIsE1/PepClO lgG/lgM Test System is intended for the qualitative detection of lgG and 1gM class antibodies to VIsEl and pepClO antigens from Borrelia burgdorferi in human serum. The assay is intended for testing serum samples from symptomatic patients or those with a history of Lyme Borreliosis. All positive and equivocal specimens should be tested with a second-tier test such as Western Blot, which if positive, is supportive…
Read the full statement (119 words)
The ZEUS ELISA Borrelia VIsE1/PepClO lgG/lgM Test System is intended for the
qualitative detection of lgG and 1gM class antibodies to VIsEl and pepClO antigens from
Borrelia burgdorferi in human serum. The assay is intended for testing serum samples
from symptomatic patients or those with a history of Lyme Borreliosis. All positive and
equivocal specimens should be tested with a second-tier test such as Western Blot,
which if positive, is supportive evidence of infection with Borrelia burgdorferi. Diagnosis
of Lyme Borreliosis should be made based on the presence of B. burgdorferi antibodies,
history, symptoms, and other laboratory data. Negative first or second tier results
should not be used to exclude Borreliasis. This kit is for in vitro diagnostic use.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K113397 · printed Nov 4, 2026
Cite this page
510(k) Report. “K113397: Zeus Elisa Borrelia Vlse-1/PEPC10 Igg/Igm Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K113397
Report an extraction error
Are you the manufacturer?
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