# K161139: LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set

- Pathway: 510(k) (Traditional)
- Applicant: DiaSorin, Inc.
- Decided: Jul 22, 2016 after 91 days
- Product code: LYR (Helicobacter Pylori)
- Device class: 1
- Regulation: 21 CFR 866.3110
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K010668 (2001). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000463: Immulite H. Pylori Igg and Immulite 2000 H. Pylori Igg, Diagnostic Products Corp. (2000) Summary page 4.
- K132234: Liaison (R) Toxo Igg II, Liaison (R) Control Toxo Igg II, DiaSorin, Inc. (2013) Summary page 4.

## Most influential descendants
- K181464: LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set (2018), 0 descendants of its own

## Indications for use
The LIAISON® H. pylori IgG assay uses chemiluminescent immunoassay (CLIA) technology for the qualitative determination of IgG antibodies to Helicobacter pylori in human serum from symptomatic adults as an aid in the diagnosis of Helicobacter pylori infection. Assay results should be used in conjunction with other clinical or laboratory data to assist the clinician in making individual patient management decisions. The test has to be performed on the LIAISON® XL Analyzer. The LIAISON® H. pylori IgG Control Set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® H. pylori IgG assay.

Source page: https://510kreport.com/device/K161139
Methodology: https://510kreport.com/methodology