(223 days)
No
The summary describes a standard immunoassay and clinical analyzer system. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies focus on analytical performance metrics like linearity, precision, and method comparison, not clinical performance metrics derived from AI/ML analysis.
No
The device is an in vitro diagnostic device used for measuring cortisol levels, which aids in the diagnosis and treatment of adrenal gland disorders, but it does not directly provide therapy.
Yes
The device is described as a "competitive binding immuno-enzymatic assay designed for use on Beckman Coulter's Access immunoassay analyzers in a clinical laboratory setting" and the "DxC 500i Clinical Analyzer... is for in vitro diagnostic use only." The text explicitly states that "Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland," indicating a diagnostic purpose.
No
The device description clearly outlines a physical instrument (DxC 500i Clinical Analyzer) that combines a chemistry analyzer and an immunoassay system. It also describes a specific assay (Access Cortisol assay) which is a paramagnetic particle, chemiluminescent immunoassay, indicating the use of physical reagents and processes. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The DxC 500i Clinical Analyzer... is for in vitro diagnostic use only." and "The immunoassay module of the DxC 500i Clinical Analyzer is an in-vitro diagnostic device...".
- Purpose: The device is intended to measure cortisol levels in human serum, plasma, and urine. This is a test performed in vitro (outside the body) on biological samples to provide information for the diagnosis and treatment of disorders.
- Clinical Context: The measurements are used "in the diagnosis and treatment of disorders of the adrenal gland," which is a clear clinical application.
- Device Description: The description details a system designed for use in a "clinical laboratory setting," further supporting its IVD nature.
N/A
Intended Use / Indications for Use
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 (OC) material and other accessories. The immunoassay module of the DxC 500i Clinical Analyzer is an in-vitro diagnostic device used for the quantitative, semiquantitative, or qualitative determination of various analyte concentrations found in human body fluids.
Product codes (comma separated list FDA assigned to the subject device)
CGR, JJE
Device Description
The Access Cortisol assay is a competitive binding immuno-enzymatic assay designed for use on Beckman Coulter's Access immunoassay analyzers in a clinical laboratory setting. Table 1 summarizes the device characteristics of the Access Cortisol assay on the DxC 500i Clinical Analyzer.
The DxC 500i Clinical Analyzer is an integrated chemistry-immunoassay work cell that combines Beckman Coulter's DxC 500 AU Clinical Chemistry Analyzer and the Access 2 Immunoassay System into a single instrument presentation. The DxC 500i instrument has a single user interface and common point of entry for sample racks; the sample handling unit operates as a parallel processor and sample manager for both sides of the instrument. The DxC 500i operates in conjunction with the existing reagents, calibrators, controls, and system solutions for the AU and Access instrument families.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Adrenal gland
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical laboratory setting
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Substantial equivalence was demonstrated through non-clinical (bench) studies. CLSI study protocols were used to ensure that the technological differences between the candidate and predicate analyzer models did not adversely affect safety and effectiveness; these performance evaluations included method comparison, linearity, imprecision, and detection limit studies. Additional studies were conducted for carryover and thermal sensitivity.
The method comparison studies between the Access Cortisol assay on the DxC 500i Clinical Analyzer and the Access Cortisol assay on the Access 2 Immunoassay System were designed in accordance with CLSI Guideline EP09C-ED3, Measurement Procedure Comparison and Bias Estimation Using Patient Samples: Third Edition. The study evaluated both serum and urine using test samples that spanned the measuring range of the assay (2.3 - 60.0 µg/dL). The test results met the slope criteria of 1.00 ± 0.12 using Weighted Deming regression analysis.
Linearity studies were designed in accordance with CLSI Guideline EP06-ED2:2020, Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline, 2nd Edition. The Access Cortisol assay was determined to be linear throughout the analytical measuring range on the DxC 500i analyzer.
Repeatability (within-run) and within-laboratory (total) precision studies followed CLSI guideline EP05-A3, Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline - Third Edition. The Access Cortisol assay met the established performance specification for allowable imprecision of
§ 862.1205 Cortisol (hydrocortisone and hydroxycorticosterone) test system.
(a)
Identification. A cortisol (hydrocortisone and hydroxycorticosterone) test system is a device intended to measure the cortisol hormones secreted by the adrenal gland in plasma and urine. Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.(b)
Classification. Class II.
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March 5, 2025
Beckman Coulter, Inc. Mary Beth Tang Senior Staff Regulatory Affairs 250 South Kraemer Boulevard Brea, California 92821
Re: K242190
Trade/Device Name: Access Cortisol; DxC 500i Clinical Analyzer Regulation Number: 21 CFR 862.1205 Regulation Name: Cortisol (Hydrocortisone and Hydroxycorticosterone) Test System Regulatory Class: Class II Product Code: CGR, JJE Dated: January 24, 2025 Received: January 24, 2025
Dear Mary Beth Tang:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
2
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Paula V. Caposino -S
Paula V. Caposino, Ph.D. Deputy Division Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K242190
Device Name Access Cortisol; DxC 500i Clinical Analyzer
Indications for Use (Describe)
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 (OC) material and other accessories. The immunoassay module of the DxC 500i Clinical Analyzer is an in-vitro diagnostic device used for the quantitative, semiquantitative, or qualitative determination of various analyte concentrations found in human body fluids.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Submitted By:
Mary Beth Tang Senior Staff Regulatory Affairs Beckman Coulter, Inc. 250 S. Kraemer Boulevard Brea, CA 92821 Telephone: 714-961-3728 Fax: 714-961-4234 Email: mbtang@beckman.com
Date of Preparation:
March 4, 2025
Device Name(s):
| Proprietary Name: | Access Cortisol |
|---|---|
| Common Name: | Cortisol (hydrocortisone and hydroxycorticosterone) test system |
| Classification Name: | Radioimmunoassay, Cortisol |
| Class: | Class II |
| Regulation Number: | 21 CFR 862.1205 |
| Product Code: | CGR |
| Proprietary Name: | DxC 500i Clinical Analyzer |
| Common Name: | Discrete photometric analyzer for clinical use |
| Classification Name: | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use |
| Class: | Class I |
| Regulation Number: | 21 CFR 862.2160 |
| Product Code: | JJE |
Predicate Device:
| Candidate Test System | Predicate Test System | Predicate Docket |
|---|---|---|
| Access Cortisol on the DxC 500i | ||
| Clinical Analyzer | Access Cortisol on the Access 2 | |
| Immunoassay System | K050202 |
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Device Description:
The Access Cortisol assay is a competitive binding immuno-enzymatic assay designed for use on Beckman Coulter's Access immunoassay analyzers in a clinical laboratory setting. Table 1 summarizes the device characteristics of the Access Cortisol assay on the DxC 500i Clinical Analyzer.
The DxC 500i Clinical Analyzer is an integrated chemistry-immunoassay work cell that combines Beckman Coulter's DxC 500 AU Clinical Chemistry Analyzer and the Access 2 Immunoassay System into a single instrument presentation. The DxC 500i instrument has a single user interface and common point of entry for sample racks; the sample handling unit operates as a parallel processor and sample manager for both sides of the instrument. The DxC 500i operates in conjunction with the existing reagents, calibrators, controls, and system solutions for the AU and Access instrument families.
Indications for Use:
The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the guantitative 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, or qualitative determination of various analyte concentrations found in human body fluids.
Comparison to the Predicate:
The Access Cortisol assay run on the DxC 500i Clinical Analyzer was compared to the Access Cortisol assay run on the stand-alone Access 2 Immunoassay System. Tables 1 and 2 compare the assay and instrument platform characteristics, respectively. The information from the predicate device was derived from the predicate device 510(k) Summary and product labeling.
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| Feature | Predicate Device:
Access Cortisol assay
on the Access 2 Immunoassay System
(K050202) | Candidate Device:
Access Cortisol assay
on the DxC 500i
Clinical Analyzer |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| Intended Use/
Indications for Use | 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. | Same |
| Methodology | Competitive binding immunoassay with
chemiluminescence detection (automated) | Same |
| Solid Phase | Paramagnetic particles coated with goat anti-rabbit
lgG | Same |
| Conjugate | Cortisol-alkaline phosphatase (bovine) conjugate | Same |
| Substrate | Access Substrate | Same |
| Calibrators | Human serum containing cortisol (purified chemical
compound) at levels of 0 and approximately 2, 5,
10, 25, and 60 µg/dL | Same |
| Traceability | USP Reference Material | Same |
| Calibration Stability | 28 days | Same |
| Reagent Open-Pack
Stability | Stable at 2 to 10°C for 14 days after initial use | Same |
| Sample Type | Serum, plasma, urine | Same |
| Measuring Range | 0.4 to 60.0 µg/dL | 2.3 to 60.0 µg/dL |
| Instrument | Access 2 | Access 2 and DxC 500i
Clinical Analyzer |
| Reagent IFU | A33262 | D12398A |
Table 1 Predicate Device Comparison (Assay)
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| Feature | Predicate Device: K121214,
Access 2 Immunoassay System | Candidate Device:
DxC 500i Clinical Analyzer |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Access 2 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. | 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. |
| Analytical
Modules | Access 2 Immunoassay Analyzer
with closed chemiluminescence
module | A modified Access 2 system serves as the
immunoassay module in the DxC 500i work
cell configuration. Beckman Coulter's DxC
500 AU Clinical Chemistry Analyzer serves
as the chemistry module in the DxC 500i
work cell configuration. The analytical
processes on both analytical modules are
identical to those on the respective stand-
alone analyzers; technological
characteristics, sample and reagent
dispensing, chemistry analysis, and data
reduction modules are all unchanged. |
| Test Systems | Menu of cleared and exempt Access
assays; user-enabled system
configuration. | Menu of cleared and exempt Access
(immunoassay) and AU (chemistry) assays;
user-enabled system configuration. |
| Assay
Parameters | Database of Access Assay Protocol
Files for Access 2 Systems | Same for immunoassay module; chemistry
module uses current AU assay settings. |
| System Console | Access 2 console for hardware
configuration as currently marketed | Shared console for the integrated hardware
configuration; manages combined chemistry
and immunoassay module operations. |
| Feature | Predicate Device: K121214, Access 2 Immunoassay System | Candidate Device: DxC 500i Clinical Analyzer |
| GUI Application | User interface unique to Access 2 Systems | User interface common to new Beckman Coulter analyzers |
| Specimen Types | Serum, plasma, urine, amniotic fluid, whole blood hemolysate (off-line preparation) | Same; chemistry module includes whole blood (online hemolysate preparation) |
| Sample Input | Sample rack load area with a sample wheel that accommodates all sample types (routine, STAT, QC, calibration) | Shared sample input area: Continuous sample loading (routine, STAT, QC, calibration, maintenance) from single point of entry on the shared sample handler. |
| Sample Handling | Open primary tubes/cups loaded in a unique 10-tube rack, continuous loading (patient, STAT, QC, calibration, maintenance samples) | Open primary tubes/cups loaded in a 7-tube rack common to new Beckman Coulter analyzers, continuous loading (patient, STAT, QC, calibration, maintenance samples) |
| Sample Identification | Stationary internal barcode reader | Dynamic barcode reader attached to the rack shuttle on the shared sample handler |
| Reagent Loading | Internal fixed barcode reader with refrigerated onboard storage; reagents can be loaded during instrument measurement cycle. | Same |
| Results Management | The analytical module collects and sends the response data to the instrument console and calculates the final test results for reporting | Same; the shared console collates the chemistry and immunoassay test results. |
| Track Connectivity | No | Same |
Table 2 Predicate Device Comparison (Instrument)
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K242190 510(k) Summary
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Comparison Testing:
Substantial equivalence was demonstrated through non-clinical (bench) studies. CLSI study protocols were used to ensure that the technological differences between the candidate and predicate analyzer models did not adversely affect safety and effectiveness; these performance evaluations included method comparison, linearity, imprecision, and detection limit studies. Additional studies were conducted for carryover and thermal sensitivity.
Summary of Performance Data:
The method comparison studies between the Access Cortisol assay on the DxC 500i Clinical Analyzer and the Access Cortisol assay on the Access 2 Immunoassay System were designed in accordance with CLSI Guideline EP09C-ED3, Measurement Procedure Comparison and Bias Estimation Using Patient Samples: Third Edition. The study evaluated both serum and urine using test samples that spanned the measuring range of the assay (2.3 - 60.0 µg/dL). The test results met the slope criteria of 1.00 ± 0.12 using Weighted Deming regression analysis.
| Sample
Type | Concentration
Range
(µg/dL) | N | Slope | Slope 95% CI | Intercept
(µg/dL) | Correlation
Coefficient
(r) |
|----------------|-----------------------------------|-----|-------|---------------|----------------------|-----------------------------------|
| Serum | 2.3 – 56.2 | 104 | 0.974 | 0.952 - 0.996 | 0.33 | 0.993 |
| Urine* | 3.1 - 59.0 | 115 | 1.002 | 0.976- 1.029 | 0.18 | 0.992 |
*Unextracted, random collection
Linearity studies were designed in accordance with CLSI Guideline EP06-ED2:2020, Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline, 2nd Edition. The Access Cortisol assay was determined to be linear throughout the analytical measuring range on the DxC 500i analyzer.
Repeatability (within-run) and within-laboratory (total) precision studies followed CLSI guideline EP05-A3, Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline - Third Edition. The Access Cortisol assay met the established performance specification for allowable imprecision of