# K032188: Nichols Advantage Aldosterone Assay

- Pathway: 510(k) (Traditional)
- Applicant: Nichols Institute Diagnostics
- Decided: Jul 31, 2003 after 14 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: 1 generation back to K831178 (1983). 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)
- K831178: Coat-a-Count NO-Extraction Aldosterone, Diagnostic Products Corp. (1983) Summary page 1.

## Indications for use
The Nichols Advantage" Aldosterone assay is intended for use with the Nichols Advantage@ Specialty System to quantitatively measure aldosterone in human serum and EDTA plasma. Aldosterone measurements are used 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/K032188
Methodology: https://510kreport.com/methodology