510(k) · Cleared
ClearedAthena Multi-Lyte Borrelia Vlse-1/PEPC10 Plus 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 6, 2010 after a 113-day review. The FDA summary names its predicate without a number.
- Decided
- Jul 6, 2010
- Review
- 113 days
- Class
- Class II
- Product code
- LSR
- 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 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 12.5 · 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? (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 |
|---|---|---|---|
| * | — | Zeus Scientific Borrelia burgdorferi ELISA Test System 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 LSR devicesLSR Reagent, Borrelia Serological Reagent: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Scientific, Inc AtheNA Multi-Lyte Borrelia VIsE-1/ pepClO Plus Test System is a multiplexed sandwich immunoassay for the qualitative detection of lgG class antibody to recombinant VIsE-1 and the 1gM class of antibody to synthetic pepClO in human serum. The AtheNA Multi-lyte Borrelia VIsE-1/pepClO Plus Test System isintended for use with the Luminex®l 200 ISand the AtheNA Multi-Lyte data management package in testing serum samples from…
Read the full statement (140 words)
The Zeus Scientific, Inc AtheNA Multi-Lyte Borrelia VIsE-1/ pepClO Plus Test System is a multiplexed sandwich immunoassay for the qualitative detection of lgG class antibody to recombinant VIsE-1 and the 1gM class of antibody to synthetic pepClO in human serum. The AtheNA Multi-lyte Borrelia VIsE-1/pepClO Plus Test System isintended for use with the Luminex®l 200 ISand the AtheNA Multi-Lyte data management package in testing serum samples from symptomatic patients or those with a history of Lyme Borreliosis. All positive specimens should be tested with a second-tier test such as Western Blot which if positive, issupportive evidence of infection with B&burgdorferi. Diagnosis of 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 Borreliosis.
This kit isfor in vitro diagnostic use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100728 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100728: Athena Multi-Lyte Borrelia Vlse-1/PEPC10 Plus 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/K100728
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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