510(k) · Cleared
ClearedAxsym Cortisol Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujirebio Diagnostics,Inc. · JFT Fluorometric, Cortisol
Cleared on Feb 20, 2004 after an 84-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- Feb 20, 2004
- Review
- 84 days
- Class
- Class II
- Product code
- JFT
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K033731 | Axsym Cortisol Assay | Fujirebio Diagnostics,Inc. | 2004 | — |
| +1 | K062204 | Architect Cortisol Assay | Seradyn, Inc. | 2006 | — |
| +2 | K242505 | Elecsys Cortisol III | Roche Diagnostics | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2025 | 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 JFT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JFT device
- #1 K242505 Elecsys Cortisol IIIscore 10.0 · 2 generations · no Class I recall
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | — | Beckman Access® Cortisol assay Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062204 | Architect Cortisol Assay | 2006 | 1 |
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, K062204 (Seradyn, Inc., 2006) has gone furthest, with 1 descendant of its own.
How does its category compare?
All JFT devicesJFT Fluorometric, Cortisol: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JFT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JFT
Too few JFT 510(k)s in any year since 2007 to give a median.
Recalls per year · JFT
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JFT
9in 2025
MAUDE reports naming product code JFT, 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 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 1 | 16 |
| 2013 | 0 | — | 0 | 6 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 1 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 1 | — | 0 | 9 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The AxSYM® Cortisol assay is a Fluorescence Polarization Immunoassay (FPIA) for the quantitative measurement of Cortisol in human serum, plasma or urine on the AxSYM® System to aid in the diagnosis and treatment of adrenal disorders.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033731 · printed Nov 4, 2026
Cite this page
510(k) Report. “K033731: Axsym Cortisol Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K033731
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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