# K142038: EUROIMMUN LYME ELISA (IgG/IgM)

- Pathway: 510(k) (Traditional)
- Applicant: Euroimmun US
- Decided: May 4, 2015 after 280 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 EUROIMMUN Lyme ELISA (IgG/IgM) test kit is intended for the qualitative determination of IgG and/or IgM class antibodies against Borrelia burgdorferi in human serum and plasma (K+-EDTA, Li+-heparin) from symptomatic patients or people suspected of B. burgdorferi infection. It is used as an aid in the diagnosis of Lyme disease, in conjunction with other laboratory and clinical findings. All positive and borderline results should be supplemented by a second step testing method such as Western blot.

Source page: https://510kreport.com/device/K142038
Methodology: https://510kreport.com/methodology