# K894293: Mardx Lyme Disease Eia (Igm) Test System

- Pathway: 510(k) (Traditional)
- Applicant: Mardx Diagnostics, Inc.
- Decided: Aug 21, 1989 after 59 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.
7 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K081362: Platelia Lyme Igm (2008), 4 descendants of its own
- K122979: Vidas Lyme Igm (2013), 3 descendants of its own
- K173691: Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack (2018), 1 descendant of its own
- K254295: Sofia Lyme FIA; Sofia 2 Campylobacter FIA (2026), 0 descendants of its own
- K203295: Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit (2021), 0 descendants of its own

Source page: https://510kreport.com/device/K894293
Methodology: https://510kreport.com/methodology