Who is the manufacturer of Access Testosterone?

Beckman Coulter, Inc. filed the 510(k) submission for Access Testosterone (K223405).

What is the FDA product code for Access Testosterone?

CDZ. It is classified under 21 CFR 862.1680 as a Class 1 device in the Clinical Chemistry panel.

What is the regulatory pathway for Access Testosterone?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Access Testosterone?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Access Testosterone

K223405 · Beckman Coulter, Inc. · CDZ · Jan 13, 2023 · Clinical Chemistry

Device Facts

Record ID	K223405
Device Name	Access Testosterone
Applicant	Beckman Coulter, Inc.
Product Code	CDZ · Clinical Chemistry
Decision Date	Jan 13, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1680
Device Class	Class 1

Intended Use

The Access Testosterone assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total testosterone levels in human serum and plasma using the Access Immunoassay Systems. Measurement of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.

Device Story

Access Testosterone assay is a competitive binding immunoenzymatic assay; utilizes paramagnetic particles and chemiluminescence. Input: human serum or plasma samples. Operation: automated on Dxl 9000 Access Immunoassay Analyzer; reagent pack, calibrators, substrate (Lumi-Phos PRO), and wash buffer used. Output: quantitative total testosterone concentration. Used in clinical laboratory settings by trained laboratory personnel. Healthcare providers use results to diagnose/treat androgen-related conditions (e.g., hypogonadism, hirsutism, virilization). Benefits: provides standardized, automated measurement of testosterone levels to support clinical decision-making.

Clinical Evidence

Bench testing only. Method comparison study (n=108 serum samples) demonstrated equivalence to the predicate (R²=0.98, slope 0.95). Linearity verified across 0.4–16.0 ng/mL range. Precision studies (repeatability, within-run, between-run, between-day) met acceptance criteria (SD ≤ 0.14 ng/mL for concentrations ≤ 1.4 ng/mL; CV ≤ 10.0% for concentrations > 1.4 ng/mL). LoB 0.2 ng/mL, LoD 0.4 ng/mL, LoQ 0.4 ng/mL.

Technological Characteristics

Competitive binding chemiluminescent immunoassay. Paramagnetic particle-based. Automated. Analyte: Testosterone. Standardization: USP reference material. Measuring range: 0.4–16.0 ng/mL. Instrument: Dxl 9000 Access Immunoassay Analyzer. Substrate: Lumi-Phos PRO. Sample types: serum, plasma (heparin).

Indications for Use

Indicated for quantitative determination of total testosterone in human serum and plasma to aid in diagnosis and treatment of androgen-related disorders, including hypogonadism, puberty disorders, and impotence in males, and hirsutism and virilization in females.

Regulatory Classification

Identification

A testosterone test system is a device intended to measure testosterone (a male sex hormone) in serum, plasma, and urine. Measurement of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.

Related Devices

K021972 — FASTPACK TOTAL TESTOSTERONE IMMUNOASSAY · Qualigen, Inc. · Aug 21, 2002
K041866 — ABBOTT AXSYM TESTOSTERONE MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) · Axis-Shield Diagnostics, Ltd. · Sep 29, 2004
K983212 — ABBOTT ARCHITECT TESTOSTERONE · Abbott Laboratories · Nov 18, 1998

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format. January 13, 2023 Beckman Coulter, Inc. Kuljeet Kaur Regulatory Affairs Manager 1000 Lake Hazeltine Drive Chaska, MN 55318 #### Re: K223405 Trade/Device Name: Access Testosterone Regulation Number: 21 CFR 862.1680 Regulation Name: Testosterone test system Regulatory Class: Class I, reserved Product Code: CDZ Dated: November 7, 2022 Received: November 9, 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 {1}------------------------------------------------ 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 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-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/Figure/6 description: The image shows a digital signature. The signature is by Paula Caposino -S. The date of the signature is 2023.01.13 and the time is 17:18:55 -05'00'. 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) k223405 Device Name Access Testosterone #### Indications for Use (Describe) The Access Testosterone assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total testosterone levels in human serum and plasma using the Access Immunoassay Systems. Measurement of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females hirsutism (excessive hair) and virilization) due to tumors, polycystic ovaries, and adrenogenital syndromes. Type of Use (Select one or both, as applicable): | <svg height="16" width="16"> <path d="M2 2 L14 14 M2 14 L14 2" stroke="black" stroke-width="2"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D) | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | □ Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red circle with two white curved lines inside, resembling a stylized wave or flow. To the right of the circle, the words "BECKMAN" and "COULTER" are written in bold, black, sans-serif font, with "BECKMAN" on the top line and "COULTER" on the bottom line. Access Testosterone ## 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: k223405 #### Submitted By: Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318 #### Primary Contact: Kuljeet Kaur, Ph.D. RAC Regulatory Affairs Manager 1000 Lake Hazeltine Drive Chaska, MN 55318 Phone: (952) 465-1914 Email: kkaur@beckman.com ## Alternate Contact: Kate Oelberg Senior Staff Regulatory and Quality Affairs Office Phone: (612) 431-7315 Email: kmoelberg@beckman.com #### Date Prepared: January 5, 2023 Common Name: Access Testosterone Assay Trade Name: Access Testosterone Classification Name: Testosterone test system Product Code: CDZ Classification Regulation: 21 CFR 862.1680 #### Predicate Device: | Predicate Device | Manufacturer | 510(k) No. | |---------------------------|-----------------------|------------| | Access Testosterone assay | Beckman Coulter, Inc. | K001935 | {4}------------------------------------------------ ## Device Description: The Access Testosterone assay is a competitive binding immunoenzymatic assay. The Access Testosterone assay consists of the reagent pack and calibrators. Other items needed to run the assay include substrate and wash buffer. The Access Testosterone assay reagent pack, Access Testosterone 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. ## Intended Use: The Access Testosterone assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total testosterone levels in human serum and plasma using the Access Immunoassay Systems. Measurement of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes. | Attribute/Characteristic | Predicate Access Testosterone on Access Immunoassay System | Access Testosterone on Dxl 9000 Access Immunoassay Analyzer | |-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------| | Intended Use/Indications for Use | The Access Testosterone assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total testosterone levels in human serum and plasma using the Access Immunoassay Systems. | Same | | Analyte Measured | Testosterone | Same | | Standardization | USP Reference Material | Same | | Technology | One-step competitive binding | Same | ## Comparison to the Predicate {5}------------------------------------------------ | Attribute/Characteristic | Predicate Access Testosterone on Access Immunoassay System | Access Testosterone on Dxl 9000 Access Immunoassay Analyzer | |-------------------------------------------|------------------------------------------------------------------|-------------------------------------------------------------------| | Format | Chemiluminescent | Same | | Method | Automated | Same | | Calibration | Utilizes a stored calibration curve | Same | | Traceability | USP reference material | Same | | Sample Type | Serum, plasma (heparin) | Same | | Stability | Stable at 2 to 10°C for 28 days after initial use | Same | | Reagent Pack formulation and packaging | Access Reagent Pack formulation and packaging. | Same | | Measuring Range | 0.1 – 16.0 ng/mL | 0.4 – 16.0 ng/mL | | Instrument | Access Immunoassay system | Dxl 9000 Access Immunoassay Analyzer | | Substrate | Access Substrate | Lumi-Phos PRO substrate | # Summary of Studies: Method Comparison: Method comparison study was performed to compare the Access Testosterone assay on Dxl 9000 Access Immunoassay Analyzer to a previously cleared system. Method comparison and bias estimation experiments were designed in accordance with the CLSI EP09c-A3 "Method Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline – Third Edition". A total of one hundred and eight (108) serum samples were evaluated in the method comparison study. The results of the method comparison study met the acceptance criteria of R2 ≥ 0.90 and slope of 1.00 ± 0.14 and support the equivalence of the Access Testosterone assay on Dxl 9000 Access Immunoassay Analyzer to the Access Testosterone assay on the Access 2 instrument. | N | Concentration Range (ng/mL) | Slope | Slope 95% CI | Intercept | Intercept 95% CI | Correlation Coefficient R2 | |-----|--------------------------------|-------|-----------------|-----------|---------------------|-------------------------------| | 108 | 0.48, 14 | 0.95 | 0.93, 0.98 | 0.028 | -0.015, 0.071 | 0.98 | {6}------------------------------------------------ Linearity: A verification study was performed to evaluate the linearity of the Access Testosterone assay on the Dxl 9000 Access Immunoassay Analyzer based on CLSI EP06-Ed2 "Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline". The low sample was a native serum sample. The high sample was created by spiking a native serum sample with Testosterone antigen. All other samples tested were mixtures of the low and high sample. The Access Testosterone assay is linear on the Dxl 9000 Access Immunoassay Analyzer throughout the analytical measuring interval of 0.4 - 16.0 ng/mL. Imprecision: Repeatability (within-run) and within-laboratory (total) precision studies were designed in accordance with the CLSI Guideline EP05-A3 "Evaluation of Precision of Quantitative Measurement Procedures: Approved Guideline - Third Edition". The study was run on three Dxl 9000 Access Immunoassay Analyzers, three reagent lots, and three calibrator lots. Six (6) serum samples with Testosterone concentrations spanning the range of the assay were each tested in replicates of two (2) per run with two (2) runs per day with a minimum of 20 days on each instrument and reagent lot combination. Two (2) samples were native serum samples from individual donors, three (3) were native pooled serum samples and one (1) sample was prepared by spiking native serum samples with an antigen to achieve adequate coverage at the high end of the analytical range. The assay was designed to have within-laboratory imprecision as listed below: • ≤ 0.14 ng/mL (0.49 nmol/L) SD at concentrations ≤ 1.4 ng/mL (4.9 nmol/L) • ≤ 10.0% CV at concentrations > 1.4 ng/mL (4.9 nmol/L) | Concentration (ng/mL) | Repeatability (Within-run) | Between-run | | Between-day | | Within- Laboratory | | | | | |-----------------------|-------------------------------|-------------|------|-------------|------|-----------------------|------|-----|------|-----| | Sample | N | Mean | SD | %CV | SD | %CV | SD | %CV | SD | %CV | | Sample 1 | 88 | 0.71 | 0.03 | 3.6 | 0.02 | 3.4 | 0.02 | 3.4 | 0.04 | 6.0 | | Sample 2 | 88 | 2.0 | 0.05 | 2.6 | 0.05 | 2.6 | 0.05 | 2.3 | 0.09 | 4.4 | | Sample 3 | 88 | 4.8 | 0.09 | 1.9 | 0.08 | 1.7 | 0.14 | 3.0 | 0.19 | 3.9 | The results from a representative lot are as follows: {7}------------------------------------------------ | Concentration (ng/mL) | | | Repeatability (Within-run) | | Between-run | | Between-day | | Within- Laboratory | | |-----------------------|----|-----|-------------------------------|-----|-------------|-----|-------------|-----|-----------------------|-----| | Sample 4 | 88 | 7.1 | 0.13 | 1.8 | 0.09 | 1.2 | 0.29 | 4.0 | 0.33 | 4.6 | | Sample 5 | 88 | 8.6 | 0.18 | 2.1 | 0.25 | 2.9 | 0.40 | 4.7 | 0.51 | 5.9 | | Sample 6 | 88 | 14 | 0.3 | 2.2 | 0.2 | 1.6 | 1.0 | 7.3 | 1.1 | 7.8 | LoB, LoD and LoQ: Limit of Blank (LoB), Limit of Detection (LoD), and Limit of Quantitation (LoQ) studies were designed from the CLSI quideline EP17-A2 "Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures Approved Guideline - Second Edition". Four blank samples (Matrix lacking Testosterone antigen) were used for LoB determination. For estimation of LoD, seven serum samples containing low levels of Testosterone analyte were measured. For estimation of LoQ, 12 serum samples containing low levels of Testosterone analyte were measured. The LoB study included multiple reagent lots and 3 Dxl 9000 Access Immunoassay Analyzers over a minimum of 3 days. The LoD and LoQ studies included multiple reagent lots and 3 Dxl 9000 Access Immunoassay Analyzers over a minimum of 5 days. The assay has an LoB of 0.2 ng/mL (0.7 nmol/L), LoD of 0.4 ng/mL (1.39 nmol/L) and 20% Within-Laboratory CV LoQ of 0.4 ng/mL (1.39 nmol/L). Other claims: The claims for the analytical specificity, reference intervals, matrix comparison are being transferred from file k001935. ## Substantial Equivalence Comparison Conclusion Beckman Coulter's Testosterone Assay on the Dxl 9000 Access Immunoassay Analyzer is substantially equivalent to the Access Testosterone Assay on the Access Immunoassay System as demonstrated through the information and data provided in this submission. The performance testing presented in this submission provides evidence that the device is safe and effective in its intended use.