510(k) Report

510(k) · Cleared

Cleared

Coat-a-Count NO-Extraction Aldosterone

K831178510(k) TraditionalCleared May 27, 198346-day reviewClass II21 CFR 862.1045

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Diagnostic Products Corp. · CJM Radioimmunoassay, Aldosterone

Cleared on May 27, 1983 after a 46-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
May 27, 1983
Review
46 days
Class
Class II
Product code
CJM
Recalls
None
Predicates
0

3 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2015: 1 descendant cleared2003: 1 descendant cleared2013: 1 descendant cleared19801990200020102020
  1. This deviceK831178 Coat-a-Count NO-Extraction AldosteroneDiagnostic Products Corp. · 1983
  2. Descendant · cites it directly · 0 of its ownK142994 IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS…Immunodiagnostic Systems, Ltd. · 2015
  3. Descendant · cites it directly · 0 of its ownK130321 Liaison Aldosterone, Liaison Aldosterone Control Set, Liaison…Diasorin · 2013
  4. Descendant · cites it directly · 0 of its ownK032188 Nichols Advantage Aldosterone AssayNichols Institute Diagnostics · 2003

Most influential descendants

Showing 3 of 3 · See all
  • K142994IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone…Immunodiagnostic Systems, Ltd. · 2015 · cites it directly0descendants
  • K130321Liaison Aldosterone, Liaison Aldosterone Control Set, Liaison Aldosterone Calibration…Diasorin · 2013 · cites it directly0descendants
  • K032188Nichols Advantage Aldosterone AssayNichols Institute Diagnostics · 2003 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K831178Coat-a-Count NO-Extraction AldosteroneDiagnostic Products Corp.1983—
+1K142994IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS…Immunodiagnostic Systems, Ltd.2015—
+1K130321Liaison Aldosterone, Liaison Aldosterone Control Set, Liaison Aldosterone…Diasorin2013—
+1K032188Nichols Advantage Aldosterone AssayNichols Institute Diagnostics2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
201310
201510
FIG. 1 — Lineage of K831178, 1983–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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.

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  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (3)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K142994IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone…Immunodiagnostic Systems, Ltd.20150
K130321Liaison Aldosterone, Liaison Aldosterone Control Set, Liaison Aldosterone Calibration…Diasorin20130
K032188Nichols Advantage Aldosterone AssayNichols Institute Diagnostics20030

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?

  • Of its descendants, K142994 (Immunodiagnostic Systems, Ltd., 2015) has gone furthest, with 0 descendants of its own.

How does its category compare?

All CJM devices

CJM Radioimmunoassay, Aldosterone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CJM

1in 2015

2013: 12015: 1
2007high 1 (2013) · low 0 (2007)2026

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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20131—00
20140—00
20151—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Diagnostic Products Corp.

321 FDA decisions under this applicant name. See the company

  • K063045Immulite 2000, Immulite 2500 VancomycinDiagnostic Products Corp. · 2006
  • K034055Immulite 2500 CK-MB, 2500 Myoglobin, 2500 Stat Troponin IDiagnostic Products Corp. · 20041 recall
  • K033234Immulite 2500 Automated Immunoassay AnalyzerDiagnostic Products Corp. · 20033 recalls
  • K032881Immulite/Immulite 1000 Total Testosterone and Immulite 2000 Total TestosteroneDiagnostic Products Corp. · 20032 recalls
  • K023152Immulite 2000 Allergen-Specific IgeDiagnostic Products Corp. · 2002

Recent decisions in CJM

The CJM category page

  • K142994IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration VerifiersImmunodiagnostic Systems, Ltd. · 2015
  • K130321Liaison Aldosterone, Liaison Aldosterone Control Set, Liaison Aldosterone Calibration VerifiersDiasorin · 2013
  • K050784Nichols Advantage Aldosterone AssayNichols Institute Diagnostics · 2005
  • K032188Nichols Advantage Aldosterone AssayNichols Institute Diagnostics · 2003
  • K943397DSL Active Aldosterone Ria (DSL 8600)Diagnostic Systems Laboratories, Inc. · 1995

https://510kreport.com/device/K831178 · printed Nov 6, 2026

Cite this page

510(k) Report. “K831178: Coat-a-Count NO-Extraction Aldosterone.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K831178

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026