# K100728: Athena Multi-Lyte Borrelia Vlse-1/PEPC10 Plus Test System

- Pathway: 510(k) (Traditional)
- Applicant: Zeus Scientific, Inc.
- Decided: Jul 6, 2010 after 113 days
- Product code: LSR (Reagent, Borrelia Serological Reagent)
- Device class: 2
- Regulation: 21 CFR 866.3830
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Zeus Scientific Borrelia burgdorferi ELISA Test System: named in the summary without a submission number

## Indications for use
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.

Source page: https://510kreport.com/device/K100728
Methodology: https://510kreport.com/methodology