510(k) · Cleared
ClearedIDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration Verifiers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Immunodiagnostic Systems, Ltd. · CJM Radioimmunoassay, Aldosterone
Cleared on Apr 21, 2015 as substantially equivalent to K831178 (Diagnostic Products Corp., 1983) and 2 other predicates after a 187-day review. Its family tree reaches back 1 generation to 1983.
- Decided
- Apr 21, 2015
- Review
- 187 days
- Class
- Class II
- Product code
- CJM
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K831178 (1983). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK831178 Coat-a-Count NO-Extraction AldosteroneDiagnostic Products Corp. · 1983
- This deviceK142994 IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS…Immunodiagnostic Systems, Ltd. · 2015
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) | K142994 | IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS… | Immunodiagnostic Systems, Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 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 4…use. We claim equivalency to the currently marketed Siemens Healthcare Diagnostics Ltd. Coat-A-Count® Aldosterone; TKAL 6615154 (K831178). The IDS-iSYS Aldosterone Calibration Verifiers are substantially equivalent to other prod… | 1983 |
| * | K111650 | Ids-Isys CTX-1 (Crosslaps) Calibration Verifiers, Ids-Isys 25 Hydroxy Vitamin D…Summary page 5…Page 1(12) IDS-iSYS 25-Hydroxy Vitamin DS Calibration Verifiers (K111650). The IDS-iSYS Aldosterone Control Set is substantially equivalent to other products… | 2011 |
| * | K091849 | Ids-Isys 25-Hydroxy Vitamin D Assay, Ids-Isys 25-Hydroxy Vitamin D Control SetSummary page 5…ribution intended for similar use. We claim equivalency to the currently marketed IDS-iSYS 25-Hydroxy Vitamin DS Control Set (K091849). Device Description The IDS-iSYS Aldosterone assay is based on chemiluminescence technology. A biotinylate… | 2010 |
| † | K130321 | Liaison Aldosterone, Liaison Aldosterone Control Set, Liaison Aldosterone Calibration… | 2013 |
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?
- None of the 3 ancestors has a 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. 2015, 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 IDS-iSYS Aldosterone assay (IS-3300) is a device intended for use in clinical laboratories for the quantitative determination of Aldosterone in human EDTA plasma on the IDS-iSYS Multi-Discipline Automated System. 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…
Read the full statement (129 words)
The IDS-iSYS Aldosterone assay (IS-3300) is a device intended for use in clinical laboratories for the quantitative determination of Aldosterone in human EDTA plasma on the IDS-iSYS Multi-Discipline Automated System. 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 hyperaldosteronism, edematous states and other conditions of electrolyte balance.
The IDS-iSYS Aldosterone Control Set (IS-3330) is intended for use as assayed quality control samples to monitor the accuracy of the IDS-iSYS Aldosterone assay on the IDS-iSYS Multi-Discipline Automated System.
The IDS-iSYS Aldosterone Calibration Verifiers (IS-3335) are intended for medical purposes for use in the quantitative verification of calibration of the IDS-iSYS Aldosterone assay on the IDS-iSYS Multi-Discipline Automated System.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K142994 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142994: IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS 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/K142994
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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