# K991180: Borrelia Burgdorferi Igg Western Blot Test System

- Pathway: 510(k) (Traditional)
- Applicant: Zeus Scientific, Inc.
- Decided: Sep 3, 1999 after 148 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Zeus Scientific, Inc., B. burgdorferi Westem Blot Test System is designed for the qualitative detection of IgG class antibodies to “specific proteins associated with B. burgdorferi, the causative agent of Lyme Disease. The test system is intended to be used for testing human serum samples which have been found to be positive or equivocal by an EIA or IFA screening procedure. The test is therefore intended to provide supportive evidence of infection of Borrelia burgdorferi.

Source page: https://510kreport.com/device/K991180
Methodology: https://510kreport.com/methodology