# K193051: LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set

- Pathway: 510(k) (Traditional)
- Applicant: DiaSorin, Inc.
- Decided: Jan 29, 2020 after 89 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 K113397 (2012). 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)
- K113397: Zeus Elisa Borrelia Vlse-1/PEPC10 Igg/Igm Test System, Zeus Scientific, Inc. (2012) Summary page 3.

## Indications for use
LIAISON® Lyme Total Antibody Plus: The LIAISON® Lyme Total Antibody Plus assay uses chemiluminescent immunoassay (CLIA) technology for the qualitative determination of lgG and IgM antibodies to Borrelia burgdorferi in human serum and plasma (K2-EDTA, Li-heparin) samples. This assay is intended for use 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 B. burgdorferi and can be used to support a clinical diagnosis of Lyme disease. Negative results by LIAISON® Lyme Total Antibody Plus assay should not be used to exclude Lyme disease. The test has to be performed on the LIAISON® XL Analyzer. The LIAISON® Lyme Total Antibody Plus Control Set: The LIAISON® Lyme Total Antibody Plus Control Set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® Lyme Total Antibody Plus assay. The performance characteristics of LIAISON® Lyme Total Antibody Plus Control Set have not been established for any other assays or instrument platforms different from the LIAISON® XL.

Source page: https://510kreport.com/device/K193051
Methodology: https://510kreport.com/methodology