# K113846: Borrelia Burgdorferi Igm Blot Test

- Pathway: 510(k) (Traditional)
- Applicant: Gold Standard Diagnostics
- Decided: Jun 1, 2012 after 155 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 K951709 (1996). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951709: Mardx Lyme Disease (Igm) Marblot Strip Test System, Mardx Diagnostics, Inc. (1996) Summary page 1.

## Most influential descendants
- K203292: Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit (2021), 0 descendants of its own
- K203295: Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit (2021), 0 descendants of its own

## Indications for use
The Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit is intended for the qualitative detection of IgM antibodies to B. burgdorferi sensu stricto (B31) in human serum. This test is intended for use in testing human serum samples which have been found positive or equivocal using an ELISA or IFA test procedure to provide supportive evidence of infection with B. burgdorferi.

Source page: https://510kreport.com/device/K113846
Methodology: https://510kreport.com/methodology