# K950829: Mardx Lyme Disease (Igg) Marblot Strip Test System

- Pathway: 510(k) (Traditional)
- Applicant: Mardx Diagnostics, Inc.
- Decided: Jun 5, 1996 after 468 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.
5 later devices descend from it; 3 cite it directly.
0 of 6 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 no predicate by number.

## Most influential descendants
- K113847: Borrelia Burgdorferi Igg Blot Test (2012), 2 descendants of its own
- K203292: Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit (2021), 0 descendants of its own
- K203296: Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit (2021), 0 descendants of its own
- K163095: Lyme B. burgdorferi (IgG) MarStripe Test (2017), 0 descendants of its own
- K032713: Boston Biomedica, Inc. Borrelia Burgdorferi Igm and Igg (2003), 0 descendants of its own

## Indications for use
MarDx Lyme Disease (IgG) Marblot Strip Test System is a Western blot assay for the qualitative detection of human IgG antibody to B. burgdorferi. The MarDx Lyme Disease (IgG) Marblot Strip Test System is intended for use in testing human serum samples which have been found positive or equivocal using an EIA or [FA test procedure.

Source page: https://510kreport.com/device/K950829
Methodology: https://510kreport.com/methodology