510(k) Report

510(k) · Cleared

Cleared

Immulite Dhea-S04

K935806510(k) TraditionalCleared Apr 26, 1994145-day reviewClass I21 CFR 862.1245

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

Diagnostic Products Corp. · JKC Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

Cleared on Apr 26, 1994 after a 145-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Apr 26, 1994
Review
145 days
Class
Class I
Product code
JKC
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2011: 1 descendant cleared1990200020102020
  1. This deviceK935806 Immulite Dhea-S04Diagnostic Products Corp. · 1994
  2. Descendant · cites it directly · 1 of its ownK040181 Access Dhea-S Reagent AssayBeckman Coulter, Inc. · 2004
  3. Descendant · 2 generations on · 0 of its ownK111762 ST Aia-Pack Dhea-S Calibrator SetTosoh Bioscience, Inc. · 2011

Most influential descendants

Showing 2 of 2 · See all
  • K040181Access Dhea-S Reagent AssayBeckman Coulter, Inc. · 2004 · cites it directly1descendant
  • K111762ST Aia-Pack Dhea-S Calibrator SetTosoh Bioscience, Inc. · 2011 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K935806Immulite Dhea-S04Diagnostic Products Corp.1994—
+1K040181Access Dhea-S Reagent AssayBeckman Coulter, Inc.2004—
+2K111762ST Aia-Pack Dhea-S Calibrator SetTosoh Bioscience, Inc.2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
201110
FIG. 1 — Lineage of K935806, 1994–2011Source: 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 JKC? 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
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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? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K040181Access Dhea-S Reagent AssayBeckman Coulter, Inc.20041

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, K040181 (Beckman Coulter, Inc., 2004) has gone furthest, with 1 descendant of its own.

How does its category compare?

All JKC devices

JKC Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JKC

FDA has decided no JKC device since 2007.

Median 510(k) review, days · JKC

Too few JKC 510(k)s in any year since 2007 to give a median.

Recalls per year · JKC

2in 2025

2010: 12012: 12025: 2
2007high 2 (2025) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JKC

5in 2025

2016: 12017: 32018: 12019: 22020: 12021: 12022: 22024: 42025: 5
2007high 5 (2025) · low 0 (2007)2025

MAUDE reports naming product code JKC, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—10
20110—00
20120—10
20130—00
20140—00
20150—00
20160—01
20170—03
20180—01
20190—02
20200—01
20210—01
20220—02
20230—00
20240—04
20250—25
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 JKC

The JKC category page

  • K040181Access Dhea-S Reagent AssayBeckman Coulter, Inc. · 2004
  • K003174Elecsys Dhea-SRoche Diagnostics Corp. · 2001
  • K973897DHEA-SKmi Diagnostics, Inc. · 1997
  • K962895DSL Dhea-S-7Diagnostic Systems Laboratories, Inc. · 1996
  • K955114DSL Aactive Dhea Eia KitDiagnostic Systems Laboratories, Inc. · 1996

https://510kreport.com/device/K935806 · printed Nov 6, 2026

Cite this page

510(k) Report. “K935806: Immulite Dhea-S04.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K935806

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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