510(k) · Cleared
ClearedNichols Advantage Aldosterone Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nichols Institute Diagnostics · CJM Radioimmunoassay, Aldosterone
Cleared on Jul 31, 2003 as substantially equivalent to K831178 (Diagnostic Products Corp., 1983) after a 14-day review. Its family tree reaches back 1 generation to 1983.
- Decided
- Jul 31, 2003
- Review
- 14 days
- Class
- Class II
- Product code
- CJM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K831178 (1983). No later device cites it as a predicate yet.
- Root · 1 generation backK831178 Coat-a-Count NO-Extraction AldosteroneDiagnostic Products Corp. · 1983
- This deviceK032188 Nichols Advantage Aldosterone AssayNichols Institute Diagnostics · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K831178 | Coat-a-Count NO-Extraction Aldosterone | Diagnostic Products Corp. | 1983 | — |
| 0 (this device) | K032188 | Nichols Advantage Aldosterone Assay | Nichols Institute Diagnostics | 2003 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CJM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K831178 | Coat-a-Count NO-Extraction AldosteroneSummary page 1…. Comparison to Predicate Device: The Nichols Advantage@Aldosterone (Y) was compared to the DPC Coat-A-Count Aldosterone RIA (X) previously cleared by the FDA (K831178, 5/27/83). One hundred three (103) remnant serum samples in which the clinical diagnosis were unknown were assayed in… | 1983 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K831178.
How does its category compare?
All CJM devicesCJM Radioimmunoassay, Aldosterone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CJM
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · CJM
Too few CJM 510(k)s in any year since 2007 to give a median.
Recalls per year · CJM
No recall names CJM since 2007.
Adverse event reports per year · CJM
No MAUDE report names CJM since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032188 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032188: Nichols Advantage Aldosterone Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032188
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026