510(k) · Cleared
Recalled · Class II · 2023ADVIA Centaur Cortisol (COR) Assy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · JFT Fluorometric, Cortisol
Cleared on Mar 31, 2015 as substantially equivalent to K962559 (Ciba Corning Diagnostics Corp., 1996) after a 189-day review. Its family tree reaches back 1 generation to 1996. 1 later device descends from it. It has been recalled once.
- Decided
- Mar 31, 2015
- Review
- 189 days
- Class
- Class II
- Product code
- JFT
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K962559 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK962559 Acs Cortisol ImmunoassayCiba Corning Diagnostics Corp. · 1996 · Recalled
- This deviceK142723 ADVIA Centaur Cortisol (COR) AssySiemens Healthcare Diagnostics, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK192788 ADVIA Centaur Cortisol (COR)Siemens Healthcare Diagnostics, Inc. · 2019
Most influential descendants
Showing 1 of 1 · See all- K192788ADVIA Centaur Cortisol (COR)Siemens Healthcare Diagnostics, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K962559 | Acs Cortisol Immunoassay | Ciba Corning Diagnostics Corp. | 1996 | 2 |
| 0 (this device) | K142723 | ADVIA Centaur Cortisol (COR) Assy | Siemens Healthcare Diagnostics, Inc. | 2015 | — |
| +1 | K192788 | ADVIA Centaur Cortisol (COR) | Siemens Healthcare Diagnostics, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 |
|---|---|---|---|
| * | K962559 | Acs Cortisol ImmunoassaySummary page 4…hydroxycorticosterone) test system III. PREDICATE DEVICE Name of Device: ADVIA Centaur® Cortisol (COR) Assay 510 (k): k962559 Section 006, Page 1 of 12… | 1996 |
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 |
|---|---|---|---|
| K192788 | ADVIA Centaur Cortisol (COR) | 2019 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 16, 2023 | Class II | Z-1504-2023 | Under Investigation by firm | There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All JFT devicesJFT Fluorometric, Cortisol: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
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 ADVIA Centaur® Cortisol (COR) Assay is for in vitro diagnostic use in the quantitative determination of cortisol in serum or urine using the ADVIA Centaur XP system. Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142723 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142723: ADVIA Centaur Cortisol (COR) Assy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142723
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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