# K172722: Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)

- Pathway: 510(k) (Traditional)
- Applicant: Euroimmun Us, Inc.
- Decided: Dec 10, 2017 after 90 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 Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) kit is a Western blot assay intended for the qualitative determination of IgM class antibodies against Borrelia burgdorferi in human serum and plasma (K+-EDTA, Li+-heparin, Na+-citrate) samples that have been found positive or equivocal/borderline using an enzyme immunoassay (EIA) or immunofluorescence assay (IFA) test procedure for Borrelia burgdorferi antibodies. Results can be read manually or automated utilizing EUROLineScan. This test is used as an aid in the diagnosis of infections with Borrelia burgdorferi and the associated diseases, in conjunction with other laboratory and clinical findings.

Source page: https://510kreport.com/device/K172722
Methodology: https://510kreport.com/methodology