Access Cortisol

K223038 · Beckman Coulter, Inc. · CGR · Feb 8, 2023 · Clinical Chemistry

Device Facts

• Record ID: K223038
• Device Name: Access Cortisol
• Applicant: Beckman Coulter, Inc.
• Product Code: CGR · Clinical Chemistry
• Decision Date: Feb 8, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1205
• Device Class: Class 2

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 Story

Access Cortisol is a competitive binding immunoenzymatic assay for quantitative cortisol measurement. Input: human serum, plasma, or urine samples. Process: paramagnetic particles coated with goat anti-rabbit IgG bind cortisol; cortisol-alkaline phosphatase conjugate competes for binding sites; chemiluminescent reaction measured via Dxl 9000 Access Immunoassay Analyzer. Output: quantitative cortisol concentration. Used in clinical laboratory settings by trained personnel. Results assist clinicians in diagnosing and managing adrenal gland disorders. Benefits: provides standardized hormone level assessment for clinical decision-making.

Clinical Evidence

Bench testing only. Precision/reproducibility evaluated per CLSI EP05-A3 (n=80 and n=225 per sample). Linearity evaluated per CLSI EP06-2nd edition (0.104-69.295 μg/dL range). LoB, LoD, and LoQ validated per CLSI EP17-A2. Method comparison study (n=116) against predicate device showed high correlation (r=1.00) with Passing-Bablok slope of 1.01.

Technological Characteristics

Competitive binding immunoenzymatic assay. Reagents: cortisol-alkaline phosphatase conjugate, paramagnetic particles coated with goat anti-rabbit IgG, rabbit anti-cortisol antiserum. Substrate: Lumi-Phos PRO. Instrument: DxI 9000 Access Immunoassay Analyzer. Measuring range: 0.8-60 μg/dL. Traceability: USP reference material per ISO 17511.

Indications for Use

Indicated for quantitative determination of cortisol in human serum, plasma (heparin, EDTA), and urine to aid in diagnosis and treatment of adrenal gland disorders. No specific age or gender contraindications stated.

Regulatory Classification

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.

Predicate Devices

• Cortisol And Cortisol Calibrators On The Access Immunoassay Systems (K050202)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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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)

| <span style="font-family: Arial;"> <span style="font-size: 10pt;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> </span> |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial;"> <span style="font-size: 10pt;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> |

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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: [phone] Email: [e-mail]

## Alternate Contact:

Kate Oelberg Office Phone: [phone] Email: [e-mail]

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<br>Attribute/Characteristic | Predicate Access Cortisol on Access<br>Immunoassay System | Candidate Access<br>Cortisol on Dxl 9000<br>Access<br>Immunoassay<br>Analyzer |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| Intended Use/<br>Indications for Use | The Access Cortisol assay is a<br>paramagnetic particle,<br>chemiluminescent immunoassay for the<br>quantitative determination of cortisol<br>levels in human serum, plasma<br>(heparin, EDTA) and urine using the<br>Access Immunoassay Systems. | Same |
| Solid Phase | Paramagnetic particles coated<br>with goat anti-rabbit IgG | Same |
| Conjugate | Cortisol-alkaline phosphatase<br>(bovine) conjugate | Same |
| Calibrators | Human serum containing<br>cortisol (purified chemical<br>compound) at levels of 0 and<br>approximately 2, 5, 10, 25, and 60<br>µg/dL 60 µg/dL | Same |
| Analyte Measured | Cortisol | Same |
| Traceability | USP Reference Material | Same |
| Technology | Competitive binding Immunoassay<br>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<br>Attribute/Characteristic | Predicate Access Cortisol on Access<br>Immunoassay System | Candidate Access<br>Cortisol on Dxl 9000<br>Access<br>Immunoassay<br>Analyzer |
|----------------------------------------------|-----------------------------------------------------------|-------------------------------------------------------------------------------|
| Stability | Stable at 2 to 10°C for 14 days after<br>initial use | Same |
| Reagent Pack<br>formulation and<br>packaging | Access Reagent Pack formulation and<br>packaging. | Same |
| Measuring Range | 0.4 - 60 µg/dL | 0.8 - 60 ug/dL |
| Instrument | Access Immunoassay system | Dxl 9000 Access<br>Immunoassay<br>Analyzer |
| Substrate | Access Substrate | Lumi-Phos PRO<br>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<br>Range (ug/dL) | Slope | Slope 95% CI | Intercept | Intercept<br>95% CI | Correlation<br>Coefficient<br>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<br>(Within-run) | | Between-run | | Between-day | | Within-<br>Laboratory | |
|----------|----|--------------------------|-------------------------------|------|-------------|-----|-------------|-----|-----------------------|------|
| Sample | N | Concentration<br>(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.