# K062473: Liaison Borrelia Igg/Igm Assay, Model 310870; Serum Controls, Model 310871

- Pathway: 510(k) (Traditional)
- Applicant: DiaSorin, Inc.
- Decided: Apr 12, 2007 after 231 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 K003754 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003754: Immunetics C6 Lyme Elisa Kit, Immunetics, Inc. (2001) Summary page 1.

## Indications for use
The LIAISON® Borrelia burgdorferi assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer for the qualitative presumptive detection of IgG and IgM antibodies to VIsE (variable major protein-like sequence, expressed) protein antigen of Borrelia burgdorferi in human serum. This assay should be used only on samples from patients with signs and symptoms that are consistent with Lyme disease. Positive or equivocal results should be supplemented by testing with a standardized Western blot procedure. Positive supplemental results provide evidence of exposure to Borrelia burgdorferi and can be used to support a clinical diagnosis of Lyme disease. Negative results by LIAISON® Borrelia burgdorferi should not be used to exclude Lyme disease. The LIAISON® Borrelia burgdorferi Serum Controls contains two assayed quality control sera (negative and positive) that are used to monitor the performance of the LIAISON® Borrelia burgdorferi assay.

Source page: https://510kreport.com/device/K062473
Methodology: https://510kreport.com/methodology