# K200023: Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit

- Pathway: 510(k) (Traditional)
- Applicant: Gold Standard Diagnostics
- Decided: Apr 6, 2020 after 91 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
Longest line of descent: 1 generation back to K894293 (1989). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K894293: Mardx Lyme Disease Eia (Igm) Test System, Mardx Diagnostics, Inc. (1989) Summary page 3.

## Indications for use
The Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test kit is intended as a qualitative presumptive (first step) test for the detection of IgM antibodies to B. burgdorferi sensu stricto in human serum from symptomatic patients or people suspected of infection. Positive and equivocal results must be supplemented by testing with a second-step Western blot assay.

Source page: https://510kreport.com/device/K200023
Methodology: https://510kreport.com/methodology