# K203296: Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit

- Pathway: 510(k) (Traditional)
- Applicant: Gold Standard Diagnostics
- Decided: Mar 22, 2021 after 133 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: 2 generations back to K950829 (1996). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K894224: Mardx Lyme Disease Eia (Igg) Test System, Mardx Diagnostics, Inc. (1989) Summary page 4.
- K113847: Borrelia Burgdorferi Igg Blot Test, Gold Standard Diagnostics (2012) Summary page 4.

## Indications for use
The Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit is intended as a qualitative test for the detection of IgG antibodies to B. burgdorferi sensu stricto in human serum from symptomatic patients or people suspected of infection. When used as the first-tier screening test, positive and equivocal results must be supplemented through additional testing by one of the following methods: » Standard two-tier test methodology (STTT) using an IgG blot test following current interpretation guidelines, OR » Modified two-tier test methodology (MTTT) using the Gold Standard Diagnostics Borrelia burgdorferi VISE-OspC IgG/IgM ELISA Test. The assay can also be used as a second-tier confirmation test using the MTTT methodology when used with the Gold Standard Diagnostics Borrelia burgdorferi VISE-OspC IgG/IgM ELISA Test as the first-tier screening test. Positive test results by either the STTT or MTTT methodology are supportive evidence for the presence of antibodies and exposure to Borrelia burgdorferi, the cause of Lyme disease. A diagnosis of Lyme disease should be made based on the presence of Borrelia burgdorferi antibodies, history, symptoms, and other laboratory findings.

Source page: https://510kreport.com/device/K203296
Methodology: https://510kreport.com/methodology