# K050784: Nichols Advantage Aldosterone Assay

- Pathway: 510(k) (Traditional)
- Applicant: Nichols Institute Diagnostics
- Decided: Jun 1, 2005 after 65 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) DSL-8600 ACTIVE® Aldosterone Coated-Tube Radioimmunoassay Kit: named in the summary without a submission number

## Indications for use
The Nichols Advantage Aldosterone Assay is intended for in vitro diagnostic laboratory use with the Nichols Advantage® Specialty System for quantitative measurement of aldosterone in human serum, EDTA plasma, and extracted urine. 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.

Source page: https://510kreport.com/device/K050784
Methodology: https://510kreport.com/methodology