# K965131: Borrelia Burgdorferi Igg/Igm Elisa Test System

- Pathway: 510(k) (Traditional)
- Applicant: Wampole Laboratories
- Decided: Mar 26, 1997 after 93 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. The FDA summary names its predicate without a number.
- (no number) BioWhitttaker’s Lyme STAT test: named in the summary without a submission number

## Most influential descendants
- K981913: Prevue (TM) Borrelia Burgdorferi Antibody Detection Assay (1999), 0 descendants of its own

## Indications for use
The Borrelia burgdorferi 1gG/IgM ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative presumptive detection of total (IgG/IgM) antibodies to Borrelia burgdorferi in human serum. This ELISA should only be used for patients with signs and patients with symptoms that are consistent with Lyme disease. Equivocal or positive results should be supplemented by testing with a standardized Western blot procedure. Positive supplemental results are supportive evidence of exposure to B. burgdorferi and can be used to support a clinical diagnosis of Lyme disease.

Source page: https://510kreport.com/device/K965131
Methodology: https://510kreport.com/methodology