# K181464: LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set

- Pathway: 510(k) (Traditional)
- Applicant: DiaSorin, Inc.
- Decided: Aug 31, 2018 after 88 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: 4 generations back to K010668 (2001). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053335: Premier Platinum Hpsa Plus, Models 601396, 601480, Meridian Bioscience, Inc. (2006) Summary page 4.
- K161139: LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set, DiaSorin, Inc. (2016) Summary page 4.

## Indications for use
The LIAISON® Helicobacter Antigen assay is a chemiluminescent immunoassay (CLIA) intended for the qualitative determination of Helicobacter pylori (H. pylori) antigen in human stool. The test is an aid in the diagnosis of patients suspected of H. pylori infection and to measure post therapy response from patients who have discontinued therapy for at least 4 weeks. Assay results should be used in conjunction with other clinical and laboratory data to assist the clinician in making individual patient management decisions. The test must be performed on the LIAISON® XL Analyzer. The LIAISON® Helicobacter Antigen Control Set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® Helicobacter Antigen assay. The performance characteristics of the LIAISON® Helicobacter Antigen Control Set have not been established for any other assay or instrument platforms different from the LIAISON® XL.

Source page: https://510kreport.com/device/K181464
Methodology: https://510kreport.com/methodology