510(k) · Cleared
ClearedLiaison Aldosterone, Liaison Aldosterone Control Set, Liaison Aldosterone Calibration Verifiers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diasorin · CJM Radioimmunoassay, Aldosterone
Cleared on Apr 9, 2013 as substantially equivalent to K831178 (Diagnostic Products Corp., 1983) and 2 other predicates after a 60-day review. Its family tree reaches back 3 generations to 2004.
- Decided
- Apr 9, 2013
- Review
- 60 days
- Class
- Class II
- Product code
- CJM
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K032844 (2004). 4 ancestors in all, the oldest K831178 (1983). No later device cites it as a predicate yet.
- Root · 3 generations backK032844 Liaison 25 OH Vitamin DDiaSorin, Inc. · 2004 · Recalled
- 2 generations backK071480 Liaison 25 OH Vitamin D Total; Assay, Control Set and Specimen…DiaSorin, Inc. · 2007
- 1 generation backK090104 Liaison 25 OH Vitamin D Total Calibration Verifiers, Model: 310603DiaSorin, Inc. · 2009
- This deviceK130321 Liaison Aldosterone, Liaison Aldosterone Control Set, Liaison…Diasorin · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K032844 | Liaison 25 OH Vitamin D | DiaSorin, Inc. | 2004 | 4 |
| −2 | K071480 | Liaison 25 OH Vitamin D Total; Assay, Control Set and Specimen Diluent Set… | DiaSorin, Inc. | 2007 | — |
| −1 | K090104 | Liaison 25 OH Vitamin D Total Calibration Verifiers, Model: 310603 | DiaSorin, Inc. | 2009 | — |
| 0 (this device) | K130321 | Liaison Aldosterone, Liaison Aldosterone Control Set, Liaison Aldosterone… | Diasorin | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
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? (3)
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…CJM, JJX PREDICATE DEVICE: Siemens Coat-A-Count® Aldosterone Reference K831178 LIAISON® 25 OH Vitamin D Control K071480… | 1983 |
| * | K071480 | Liaison 25 OH Vitamin D Total; Assay, Control Set and Specimen Diluent Set, Models…Summary page 1…t® Aldosterone Reference K831178 LIAISON® 25 OH Vitamin D Control K071480 LIAISON® 25 OH Vitamin D Calibration… | 2007 |
| * | K090104 | Liaison 25 OH Vitamin D Total Calibration Verifiers, Model: 310603Summary page 1…n D Control K071480 LIAISON® 25 OH Vitamin D Calibration Verifier K090104 DEVICE DESCRIPTION: INTENDED USE: The LIAISON® Aldlosterone assay uses chemiluminescent immunoassay (CLIA) technology and is in… | 2009 |
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?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 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. 2013, this device’s year, is highlighted.
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 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…
Read the full statement (135 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130321 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130321: Liaison Aldosterone, Liaison Aldosterone Control Set, Liaison Aldosterone Calibration Verifiers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130321
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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