510(k) · Cleared
Recalled · Class II · 2024Access Cortisol
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · CGR Radioimmunoassay, Cortisol
Cleared on Feb 8, 2023 as substantially equivalent to K050202 (Beckman Coulter, Inc., 2005) after a 132-day review. Its family tree reaches back 2 generations to 1995. It has been recalled once.
- Decided
- Feb 8, 2023
- Review
- 132 days
- Class
- Class II
- Product code
- CGR
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K954733 (1995). No later device cites it as a predicate yet.
- Root · 2 generations backK954733 Access Cortisol Assay (Modification)Bio-Rad Laboratories, Inc. · 1995 · Recalled
- 1 generation backK050202 Cortisol and Cortisol Calibrators on the Access Immunoassay SystemsBeckman Coulter, Inc. · 2005 · Recalled
- This deviceK223038 Access CortisolBeckman Coulter, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
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 CGR? 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 CGR device
- #1 K242190 Access Cortisol; DxC 500i Clinical Analyzerscore 7.3 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K050202 | Cortisol and Cortisol Calibrators on the Access Immunoassay SystemsSummary page 4…cation Name: Cortisol (hydrocortisone and hydroxycorticosterone) test system Classification Regulation: 21 CFR 862.1205 Predicate Device: Access Cortisol 510(k) Number: k050202 Device Description: The Access Cortisol assay is a competitive binding immunoenzymatic assay. The Access Cortisol reagent kit is… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 30, 2024 | Class II | Z-0313-2025 | Process design | The Access Cortisol assay protocol file (APF) applies an incorrect calibration curve acceptance parameter at the S1 calibrator level that can lead to a high rate of calibration failures which can vary by reagent lot number. Calibration… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 2 companies; a new generation was cleared every 18.0 years on median.
- 2 of the 2 ancestors have a recall of any class.
- 1 other device also cites its predicate K050202.
How does its category compare?
All CGR devicesCGR Radioimmunoassay, Cortisol: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · CGR
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CGR
113in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CGR
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CGR
1in 2018
MAUDE reports naming product code CGR, 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 | — | 1 | 1 |
| 2010 | 0 | — | 1 | 1 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 1 | 2 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 3 | 113 | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 1 | 0 |
| 2025 | 1 | — | 2 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cortisol levels in human serum, plasma (heparin, EDTA) and urine using the Access Immunoassay Systems.
A cortisol (hydrocortisone and hydroxycorticosterone) test system is a device intended to measure the cortisol hormones secreted by the adrenal gland in serum, plasma and urine. 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/K223038 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223038: Access Cortisol.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223038
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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