# K033070: Borrelia Burgdorferi Igm Elisa Test System

- Pathway: 510(k) (Traditional)
- Applicant: Trinity Biotech USA
- Decided: Nov 26, 2003 after 58 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 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) BioWhittaker’s Lyme M STAT test: named in the summary without a submission number

## Most influential descendants
- K203292: Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit (2021), 0 descendants of its own
- K180264: Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit (2018), 0 descendants of its own

## Indications for use
The Trinity Biotech Captia™ Borrelia burgdorferi IgM ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative presumptive detection of IgM antibodies to Borrelia burgdorferi in human serum. This ELISA should be used for patients with signs and symptoms that are consistent with Lyme disease. Equivocal or positive results must 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/K033070
Methodology: https://510kreport.com/methodology