# K122979: Vidas Lyme Igm

- Pathway: 510(k) (Traditional)
- Applicant: Biomerieux S.A.
- Decided: Jun 4, 2013 after 251 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 K894293 (1989). 2 ancestors in all.
3 later devices descend from it; 2 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)
- K081362: Platelia Lyme Igm, Bio-Rad (2008) Summary page 2.

## Most influential descendants
- 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
- K163713: Sofia Lyme FIA, Sofia Lyme Control Set (2017), 0 descendants of its own

## Indications for use
The VIDAS Lyme IgM (LYM) assay is an automated qualitative enzyme immunoassay intended for use on the instruments of the VIDAS family in the presumptive detection of human IgM antibodies to Borrelia burgdorferi in human serum (plain or separation gel) or plasma (sodium heparin or lithium heparin). It should be used to test patients with a history and/or symptoms of infection with B. burgdorferi. All VIDAS Lyme IgM-positive and equivocal specimens should be further tested with a Western Blot IgM assay to obtain supportive evidence of infection with B. burgdorferi.

Source page: https://510kreport.com/device/K122979
Methodology: https://510kreport.com/methodology