# K984138: Aptus (Automated) Application for the B. Burgdorferi Antibody Elisa Test System

- Pathway: 510(k) (Traditional)
- Applicant: Zeus Scientific, Inc.
- Decided: Mar 23, 1999 after 125 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
This test system is designed for the manual or automated, qualitative, for the presumptive (first-step) detection of IgG and/or IgM antibody to Borrelia burgdorferi in human serum from patients with history, signs, or symptoms suggestive of infection with B. burgdorferi. The test system is intended to be used as an aid in the diagnosis of Lyme disease, and is for in vitro diagnostic use.

Source page: https://510kreport.com/device/K984138
Methodology: https://510kreport.com/methodology