K Number
K223038
Device Name
Access Cortisol
Date Cleared
2023-02-08

(132 days)

Product Code
Regulation Number
862.1205
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
Device Description
The Access Cortisol assay is a competitive binding immunoenzymatic assay. The Access Cortisol reagent kit is in a liquid ready-to-use format designed for optimal performance on Beckman Coulter's immunoassay analyzers. Each reagent kit contains two reagent packs. Other items needed to run the assay include Calibrators, substrate, and wash buffer. The Access Cortisol assay reagent pack, Access Cortisol assay calibrators, along with the UniCel Dxl wash buffer II are designed for use with the Dxl 9000 Access Immunoassay Analyzer in a clinical laboratory setting.
More Information

No
The document describes a standard immunoassay for measuring cortisol levels and does not mention any AI or ML components in the device description or performance studies.

No
This device is an in vitro diagnostic (IVD) immunoassay system intended for the quantitative determination of cortisol levels, used in the diagnosis and treatment of adrenal gland disorders, not for direct therapeutic intervention.

Yes
The "Intended Use / Indications for Use" section explicitly states that "Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland." This indicates its role in identifying and managing medical conditions.

No

The device is an immunoassay kit and associated calibrators/buffers designed for use with a specific immunoassay analyzer hardware system (Beckman Coulter's immunoassay analyzers, specifically the Dxl 9000). It is a reagent-based diagnostic test, not a software-only device.

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is "for the quantitative determination of cortisol levels in human serum, plasma (heparin, EDTA) and urine." It also states that "Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland." This clearly indicates that the device is intended to be used in vitro (outside the body) to analyze biological samples (serum, plasma, urine) for diagnostic purposes.
  • Device Description: The description details a "paramagnetic particle, chemiluminescent immunoassay" and a "competitive binding immunoenzymatic assay," which are common techniques used in in vitro diagnostic tests. It also mentions the use of reagents, calibrators, substrate, and wash buffer, all components of an in vitro diagnostic system.
  • Care Setting: The intended user is in a "clinical laboratory setting," which is where in vitro diagnostic tests are typically performed.

The definition of an IVD is a medical device that is used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening. This device fits that definition perfectly.

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.

Product codes

CGR

Device Description

The Access Cortisol assay is a competitive binding immunoenzymatic assay. The Access Cortisol reagent kit is in a liquid ready-to-use format designed for optimal performance on Beckman Coulter's immunoassay analyzers. Each reagent kit contains two reagent packs. Other items needed to run the assay include Calibrators, substrate, and wash buffer. The Access Cortisol assay reagent pack, Access Cortisol assay calibrators, along with the UniCel Dxl wash buffer II are designed for use with the Dxl 9000 Access Immunoassay Analyzer in a clinical laboratory setting.

Mentions image processing

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Mentions AI, DNN, or ML

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Input Imaging Modality

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Anatomical Site

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Indicated Patient Age Range

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Intended User / Care Setting

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Description of the training set, sample size, data source, and annotation protocol

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Description of the test set, sample size, data source, and annotation protocol

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Summary of Performance Studies

Method Comparison: A method comparison study was completed to compare the Access Cortisol assay on the Dxl 9000 Access Immunoassay Analyzer to the Access Cortisol assay on the Access Immunoassay System using a protocol based on CLSI EP09c-A3. The results of the within range method comparison study met the acceptance criteria of R2 ≥ 0.90 and slope 1.00 ± 0.12 and supports the equivalence of the Access Cortisol assay on Dxl 9000 to the predicate device, the Access Cortisol assay on Access 2 Instrument.
Number (N): 116
Concentration Range (ug/dL): 1.6 - 59
Slope: 1.01
Slope 95% CI: 0.99 - 1.03
Intercept: -0.20
Intercept 95% CI: -0.41 - 0.056
Correlation Coefficient R2: 1.00

Imprecision: Verification studies were performed to determine the imprecision of the Access Cortisol assay on the Dxl 9000 Access Immunoassay Analyzer using a protocol based on CLSI EP-05-A3. The study was performed within one internal site over twenty days. Three Dxl 9000 Immunoassay Analyzers were used in the study design. There were three reagent pack lots and three calibrator lots. Five (5) serum samples, with Cortisol concentrations spanning the assay range were used for this study. The within-laboratory (total) % CV ranged from 2% to 9.3%, for Cortisol concentrations > 5.0 ug/dL. The within-laboratory (total) SD was 0.1 for Cortisol concentrations ≤ 5.0 uq/dL.

Linearity: A verification study was performed to evaluate the linearity of the Access Cortisol assay on the Dxl 9000 Access Immunoassay Analyzer based on CLSI EP06-Ed2. Acceptance criteria for non-linearity within ± 1 ug/dL for values ≤ 5.0 ug/dL and ± 20% for values > 5.0 ug/dL was met and indicate that the Access Cortisol assay is linear on the Dxl 9000 Immunoassay System across the analytical measuring interval of 0.8 -60 ug/dL (22 - 1,655 nmol/L).

LoB/LoD: Verification studies were performed to determine the Limit of Blank (LoB) and Limit of Detection (LoD) for the Access Cortisol assay on the Dxl 9000 Access Immunoassay Analyzer using a protocol based on CLSI EP17-A2. The assay is designed to meet the claimed LoB of 0.4 ug/dL and LoD of 0.4 ug/dL.

LoQ: Verification studies were performed to determine the Limit of Quantitation (LoQ) of the Access Cortisol assay on the Dxl 9000 Access Immunoassay Analyzer using a protocol based on CLSI EP17- A2. The LoQ for Access Cortisol designed to meet the claimed LoQ of 0.8 ug/dL based on a 20% CV.

Key Metrics

Not Found

Predicate Device(s)

K050202

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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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February 8, 2023

Beckman Coulter, Inc Kuljeet Kaur, Ph.D. Regulatory Affairs Manager 1000 Lake Hazeltine Drive Chaska, MN 55318

Re: K223038

Trade/Device Name: Access Cortisol Regulation Number: 21 CFR 862.1205 Regulation Name: Cortisol (hydrocortisone and hydroxycorticosterone) test system Regulatory Class: Class II Product Code: CGR Dated: September 29, 2022 Received: September 29, 2022

Dear Kuljeet Kaur:

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 (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 located 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.

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

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801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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-regulatoryassistance/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,

Image /page/1/Picture/6 description: The image shows the name "Paula Caposino -S" on the left side of the image. On the right side of the image, it says "Digitally signed by Paula Caposino -S" and "Date: 2023.02.08 17:08:10-05'00'". The text on the right side of the image indicates that the image is a digital signature.

Paula Caposino, Ph.D. Acting Deputy 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

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Indications for Use

510(k) Number (if known) K223038

Device Name Access Cortisol

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.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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Access Cortisol Assay 510 (k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92

510(k) number: K223038

Submitted By:

Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318

Contact Person:

Kuljeet Kaur, Ph.D. Phone: (952) 465-1914 Email: kkaur@beckman.com

Alternate Contact:

Kate Oelberg Office Phone: (612) 431-7315 Email: kmoelberg@beckman.com

Date Prepared: January 30, 2023

Device Common Name: Access Cortisol Assay Trade Name: Access Cortisol Classification 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 in a liquid ready-to-use format designed for optimal performance on Beckman Coulter's immunoassay analyzers. Each reagent kit contains two reagent packs. Other items needed to run the assay include Calibrators, substrate, and wash buffer. The Access Cortisol assay reagent pack, Access Cortisol assay calibrators, along with the UniCel Dxl wash buffer II are designed for use with the Dxl 9000 Access Immunoassay Analyzer in a clinical laboratory setting.

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Intended Us

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.

| System
Attribute/Characteristic | Predicate Access Cortisol on Access
Immunoassay System | Candidate Access
Cortisol on Dxl 9000
Access
Immunoassay
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. | Same |
| Solid Phase | Paramagnetic particles coated
with goat anti-rabbit IgG | Same |
| Conjugate | Cortisol-alkaline phosphatase
(bovine) conjugate | Same |
| Calibrators | Human serum containing
cortisol (purified chemical
compound) at levels of 0 and
approximately 2, 5, 10, 25, and 60
µg/dL 60 µg/dL | Same |
| Analyte Measured | Cortisol | Same |
| Traceability | USP Reference Material | Same |
| Technology | Competitive binding Immunoassay
System | Same |
| Format | Chemiluminescent | Same |
| Method | Automated | Same |
| Calibration | Utilizes a stored calibration curve | Same |
| Sample Type | Serum, plasma, or urine | Same |

Comparison of Technological Characteristics to the Predicate

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| System
Attribute/Characteristic | Predicate Access Cortisol on Access
Immunoassay System | Candidate Access
Cortisol on Dxl 9000
Access
Immunoassay
Analyzer |
|----------------------------------------------|-----------------------------------------------------------|-------------------------------------------------------------------------------|
| Stability | Stable at 2 to 10°C for 14 days after
initial use | Same |
| Reagent Pack
formulation and
packaging | Access Reagent Pack formulation and
packaging. | Same |
| Measuring Range | 0.4 - 60 µg/dL | 0.8 - 60 ug/dL |
| Instrument | Access Immunoassay system | Dxl 9000 Access
Immunoassay
Analyzer |
| Substrate | Access Substrate | Lumi-Phos PRO
substrate |

Summary of Studies:

Method Comparison: A method comparison study was completed to compare the Access Cortisol assay on the Dxl 9000 Access Immunoassay Analyzer to the Access Cortisol assay on the Access Immunoassay System using a protocol based on CLSI EP09c-A3. The results of the within range method comparison study met the acceptance criteria of R2 ≥ 0.90 and slope 1.00 ± 0.12 and supports the equivalence of the Access Cortisol assay on Dxl 9000 to the predicate device, the Access Cortisol assay on Access 2 Instrument.

| N | Concentration
Range (ug/dL) | Slope | Slope 95% CI | Intercept | Intercept
95% CI | Correlation
Coefficient
R2 |
|-----|--------------------------------|-------|--------------|-----------|---------------------|----------------------------------|
| 116 | 1.6 - 59 | 1.01 | 0.99 - 1.03 | -0.20 | -0.41 - 0.056 | 1.00 |

Imprecision: Verification studies were performed to determine the imprecision of the Access Cortisol assay on the Dxl 9000 Access Immunoassay Analyzer using a protocol based on CLSI EP-05-A3. The study was performed within one internal site over twenty days. Three Dxl 9000 Immunoassay Analyzers were used in the study design. There were three reagent pack lots and three calibrator lots. Five (5) serum samples, with Cortisol concentrations spanning the assay range were used for this study. The within-laboratory (total) % CV ranged from 2% to 9.3%, for Cortisol

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| | | Mean | Repeatability
(Within-run) | | Between-run | | Between-day | | Within-
Laboratory | |
|----------|----|--------------------------|-------------------------------|------|-------------|-----|-------------|-----|-----------------------|------|
| Sample | N | Concentration
(ug/dL) | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Sample 1 | 80 | 0.90 | 0.1 | 10.2 | 0.1 | 8.2 | 0.0 | 0.0 | 0.1 | 13.1 |
| Sample 2 | 80 | 5.7 | 0.2 | 3.4 | 0.3 | 5.5 | 0.2 | 2.7 | 0.4 | 7.1 |
| Sample 3 | 80 | 19 | 0.5 | 2.6 | 1.1 | 6.0 | 1.1 | 5.5 | 1.6 | 8.6 |
| Sample 4 | 80 | 29 | 0.8 | 2.7 | 2.0 | 6.7 | 1.7 | 5.8 | 2.7 | 9.3 |
| Sample 5 | 80 | 49 | 1.1 | 2.3 | 0.0 | 0.0 | 1.6 | 3.2 | 1.9 | 3.9 |

concentrations > 5.0 ug/dL. The within-laboratory (total) SD was 0.1 for Cortisol concentrations ≤ 5.0 uq/dL. The results from a representative lot are as follows:

Linearity: A verification study was performed to evaluate the linearity of the Access Cortisol assay on the Dxl 9000 Access Immunoassay Analyzer based on CLSI EP06-Ed2. Acceptance criteria for non-linearity within ± 1 ug/dL for values ≤ 5.0 ug/dL and ± 20% for values > 5.0 ug/dL was met and indicate that the Access Cortisol assay is linear on the Dxl 9000 Immunoassay System across the analytical measuring interval of 0.8 -60 ug/dL (22 - 1,655 nmol/L).

LoB/LoD: Verification studies were performed to determine the Limit of Blank (LoB) and Limit of Detection (LoD) for the Access Cortisol assay on the Dxl 9000 Access Immunoassay Analyzer using a protocol based on CLSI EP17-A2. The assay is designed to meet the claimed LoB of 0.4 ug/dL and LoD of 0.4 ug/dL.

LoQ: Verification studies were performed to determine the Limit of Quantitation (LoQ) of the Access Cortisol assay on the Dxl 9000 Access Immunoassay Analyzer using a protocol based on CLSI EP17- A2. The LoQ for Access Cortisol designed to meet the claimed LoQ of 0.8 ug/dL based on a 20% CV.

Other claims: The claims for the analytical specificity, reference intervals, matrix comparison are being transferred from file K050202.

Substantial Equivalence Comparison Conclusion

Beckman Coulter's Access Cortisol Assay on the Dxl 9000 Access Immunoassay Analyzer is substantially equivalent to the Access Cortisol Assay on the Access Immunoassay System as demonstrated through the information and data provided in

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this submission. The performance testing presented in this submission provides evidence that the device is safe and effective in its intended use.