# K130321: Liaison Aldosterone, Liaison Aldosterone Control Set, Liaison Aldosterone Calibration Verifiers

- Pathway: 510(k) (Traditional)
- Applicant: Diasorin
- Decided: Apr 9, 2013 after 60 days
- Product code: CJM (Radioimmunoassay, Aldosterone)
- Device class: 2
- Regulation: 21 CFR 862.1045
- 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 K032844 (2004). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K831178: Coat-a-Count NO-Extraction Aldosterone, Diagnostic Products Corp. (1983) Summary page 1.
- K071480: Liaison 25 OH Vitamin D Total; Assay, Control Set and Specimen Diluent Set, Models 310600, 310601 and 310602, DiaSorin, Inc. (2007) Summary page 1.
- K090104: Liaison 25 OH Vitamin D Total Calibration Verifiers, Model: 310603, DiaSorin, Inc. (2009) Summary page 1.

## Indications for use
The LIAISON® Aldosterone assay uses chemiluminescent inurmunoassay (CLIA) technology and is intended for the quantitative determination of Aldosterone in human serum, EDTA plasma and urine samples. Aldosterone measurements are intended for use in the diagnosis and treatment of primary aldosteronism (a disorder caused by excessive secretion of aldosterone by the adrenal gland), hypertension caused by primary aldosteronism, selective hypoaldosteronism, edematous states and other conditions of electrolyte imbalance. The test has to be performed on the LIAISON® Analyzer. The LIAISONO Aldosterone Control Set is intended for use as assayed quality control samples to monitor the accuracy of the LIAISON® Aldosterone assay on the LIAISON® Analyzer. The LIAISON® Aldosterone Calibration Verifiers are assayed quality control materials intended for the quantitative verification of calibration and reportable range of the LIAISONO Aldosterone assay when performed on the LIAISON® Analyzer.

Source page: https://510kreport.com/device/K130321
Methodology: https://510kreport.com/methodology