510(k) · Cleared
Recalled · Class II · 2026Access Cortisol; DxC 500i Clinical Analyzer
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 Mar 5, 2025 as substantially equivalent to K050202 (Beckman Coulter, Inc., 2005) and 1 other predicate after a 223-day review. Its family tree reaches back 2 generations to 1995. It has been recalled 4 times.
- Decided
- Mar 5, 2025
- Review
- 223 days
- Class
- Class II
- Product code
- CGR
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 2 generations to K954733 (1995). 5 ancestors in all, the oldest K922823 (1992). 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 deviceK242190 Access Cortisol; DxC 500i Clinical AnalyzerBeckman Coulter, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K954733 | Access Cortisol Assay (Modification) | Bio-Rad Laboratories, Inc. | 1995 | 1 |
| −1 | K050202 | Cortisol and Cortisol Calibrators on the Access Immunoassay Systems | Beckman Coulter, Inc. | 2005 | 1 |
| 0 (this device) | K242190 | Access Cortisol; DxC 500i Clinical Analyzer | Beckman Coulter, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 2005 | 1 | 0 |
| 2013 | 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 K223038 Access Cortisolscore 3.1 · 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? (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 |
|---|---|---|---|
| * | K050202 | Cortisol and Cortisol Calibrators on the Access Immunoassay SystemsSummary page 5…Candidate Test System Predicate Test System Predicate Docket Access Cortisol on the DxC 500i Access Cortisol on the Access 2 K050202 Clinical Analyzer Immunoassay System… | 2005 |
| * | K121214 | Access Accutni+3 Reagent and Access ACCUTN1+3 Calibrators for Use on the Access 2…Summary page 8…Access Cortisol on DxC 500i Table 2 Predicate Device Comparison (Instrument) Predicate Device: K121214, Candidate Device: Feature Access 2 Immunoassay System DxC 500i Clinical Analyzer Intend… | 2013 |
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 2, 2026 | Class II | Z-0083-2027 | Software design | Beckman Coulter has identified a software issue affecting DxC 500i Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry test to use units different from the system default, a subsequent… |
| Jul 15, 2026 | Class II | Z-2973-2026 | Software design (manufacturing process) | a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously modified by the user, upon import of a new Parameter Package version. As a result… |
| Sep 19, 2025 | Class II | Z-0215-2026 | Software design | Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the DxC 500i Clinical Analyzer that may prevent correct application of user-specified manual dilution factors when ordering additional tests for… |
| Aug 4, 2025 | Class II | Z-0032-2026 | Software Design Change | On a clinical analyzer, when ordering a Clinical Chemistry (CC) combination test simultaneously with an Immunoassay (IA) test, if the IA test is processed between the CC tests, CC sample status will remain In Progress with no errors, may… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 2 companies; a new generation was cleared every 20.1 years on median.
- 5 of the 5 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. 2025, 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…
Read the full statement (168 words)
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.
The DxC 500i Clinical Analyzer combines the DxC 500 AU Clinical Chemistry Analyzer and the Access 2 Immunoassay System into a single instrument presentation. The system is for in vitro diagnostic use only. The chemistry module of the DxC 500i Clinical Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. The immunoassay module of the DxC 500i Clinical Analyzer is an in-vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242190 · printed Nov 5, 2026
Cite this page
510(k) Report. “K242190: Access Cortisol; DxC 500i Clinical Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K242190
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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