510(k) · Cleared
ClearedAccess Dhea-S Reagent Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · JKC Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)
Cleared on Mar 24, 2004 as substantially equivalent to K935806 (Diagnostic Products Corp., 1994) and 1 other predicate after a 57-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.
- Decided
- Mar 24, 2004
- Review
- 57 days
- Class
- Class I
- Product code
- JKC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K935806 (1994). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K111762ST Aia-Pack Dhea-S Calibrator SetTosoh Bioscience, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K935806 | Immulite Dhea-S04 | Diagnostic Products Corp. | 1994 | — |
| 0 (this device) | K040181 | Access Dhea-S Reagent Assay | Beckman Coulter, Inc. | 2004 | — |
| +1 | K111762 | ST Aia-Pack Dhea-S Calibrator Set | Tosoh Bioscience, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K935806 | Immulite Dhea-S04Summary page 1…Number Immulite DHEA-SO4 Diagnostic Products, K935806 Access DHEA-S Reagent Corp.* Reagent… | 1994 |
| * | K003098 | Access Ultrasensitive HGH CalibratorsSummary page 1…Corp.* Reagent Access Ultrasensitive hGH Beckman Coulter, Inc. K003098 Access DHEA-S Calibrators Calibrators *Diagnostic Products, Corp., Los Angeles, C… | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111762 | ST Aia-Pack Dhea-S Calibrator Set | 2011 | 0 |
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 2 ancestors has a recall.
- Of its descendants, K111762 (Tosoh Bioscience, Inc., 2011) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JKC devicesJKC 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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JKC
5in 2025
MAUDE reports naming product code JKC, not matched to any one device; reports are not rates.
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 | — | 1 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 1 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 0 | — | 2 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Access DHEA-S assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Dehydroepiandrosterone sulfate levels in human serum and plasma using the Access Immunoassay Systems. Measurement of dehydroepiandrosterone sulfate may be used in the differential diagnosis of Cushing's syndrome, as well as in the evaluation of adrenocortical diseases, such as congenital adrenal hyperplasia and adrenal tumors. In hirsute…
Read the full statement (126 words)
The Access DHEA-S assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Dehydroepiandrosterone sulfate levels in human serum and plasma using the Access Immunoassay Systems.
Measurement of dehydroepiandrosterone sulfate may be used in the differential diagnosis of Cushing's syndrome, as well as in the evaluation of adrenocortical diseases, such as congenital adrenal hyperplasia and adrenal tumors. In hirsute female patients, increased DHEA-S levels have been associated with virilizing adrenal tumors. Patients with polycystic ovary syndrome have often demonstrated elevated levels of DHEA-S, suggesting an adrenal androgen contribution to the defect in this disorder.
The Access DHEA-S Calibrators are intended to calibrate the Access DHEA-S assay for the quantitative determination of Dehydroepiandrosterone sulfate levels in human serum and plasma using the Access Immunoassay Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040181 · printed Nov 5, 2026
Cite this page
510(k) Report. “K040181: Access Dhea-S Reagent Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040181
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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