# K113397: Zeus Elisa Borrelia Vlse-1/PEPC10 Igg/Igm Test System

- Pathway: 510(k) (Traditional)
- Applicant: Zeus Scientific, Inc.
- Decided: Jul 26, 2012 after 252 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K193051: LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set (2020), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K113397
Methodology: https://510kreport.com/methodology