510(k) · Cleared
Recalled · Class II · 2018Cortisol and Cortisol Calibrators on the Access Immunoassay Systems
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 9, 2005 as substantially equivalent to K954733 (Bio-Rad Laboratories, Inc., 1995) after a 12-day review. Its family tree reaches back 1 generation to 1995. 2 later devices descend from it. It has been recalled once.
- Decided
- Feb 9, 2005
- Review
- 12 days
- Class
- Class II
- Product code
- CGR
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K954733 (1995). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK954733 Access Cortisol Assay (Modification)Bio-Rad Laboratories, Inc. · 1995 · Recalled
- This deviceK050202 Cortisol and Cortisol Calibrators on the Access Immunoassay SystemsBeckman Coulter, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK242190 Access Cortisol; DxC 500i Clinical AnalyzerBeckman Coulter, Inc. · 2025 · Recalled
- Descendant · cites it directly · 0 of its ownK223038 Access CortisolBeckman Coulter, Inc. · 2023 · Recalled
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 |
|---|---|---|---|---|---|
| −1 | K954733 | Access Cortisol Assay (Modification) | Bio-Rad Laboratories, Inc. | 1995 | 1 |
| 0 (this device) | K050202 | Cortisol and Cortisol Calibrators on the Access Immunoassay Systems | Beckman Coulter, Inc. | 2005 | — |
| +1 | K242190 | Access Cortisol; DxC 500i Clinical Analyzer | Beckman Coulter, Inc. | 2025 | 4 |
| +1 | K223038 | Access Cortisol | Beckman Coulter, Inc. | 2023 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 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 |
|---|---|---|---|
| * | K954733 | Access Cortisol Assay (Modification)Summary page 1…fication Name: Radioimmunoassay, Cortisol Predicate Device Access Cortisol Assay Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318 510(k) Number: k954733 Beckman Coulter, Inc. Telephone: (952) 448-4848 1000 Lake Hazeltine Drive Internet: www.beckmancoult… | 1995 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 18, 2018 | Class II | Z-2763-2019 | Process design | Cross contamination may have occurred between wells for the reagent pack. As a result of this defect, patient results may be negatively impacted (falsely decreased) by up to 16%). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- Of its descendants, K242190 (Beckman Coulter, Inc., 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All CGR devicesCGR Radioimmunoassay, Cortisol: FDA decisions, review times, recalls and adverse event reports over 20 years.
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/K050202 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050202: Cortisol and Cortisol Calibrators on the Access Immunoassay Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050202
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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