(105 days)
Not Found
No
The summary describes a standard immunoassay for measuring SHBG levels and does not mention any AI or ML components in the device description, intended use, or performance studies.
No
The device is an in vitro diagnostic (IVD) assay used for the quantitative determination of Sex Hormone Binding Globulin levels, indicated for use in the assessment of androgen disorders. It does not provide therapy or treatment.
Yes
The device is described as an "immunoassay for the quantitative determination of Sex Hormone Binding Globulin levels in human serum and plasma" and is "indicated for use in the assessment of androgen disorders." This indicates its purpose is to provide information for diagnosis or assessment of a medical condition.
No
The device description explicitly states it consists of a reagent pack, calibrators, QCs, substrate, and wash buffer, all designed for use with a specific hardware analyzer (Dxl 9000 Access Immunoassay Analyzer). This indicates it is a physical assay kit used with a hardware system, 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 assay is for the "quantitative determination of Sex Hormone Binding Globulin levels in human serum and plasma". This indicates that it is used to analyze samples taken from the human body (in vitro) to provide diagnostic information.
- Device Description: The description details a "chemiluminescent immunoassay" and mentions components like "reagent pack, calibrators and QCs". These are typical components of in vitro diagnostic tests.
- Intended User / Care Setting: The device is designed for use in a "clinical laboratory setting", which is where IVD tests are performed.
- Performance Studies: The document describes various performance studies (Method Comparison, Precision, Linearity, LoB, LoD, LoQ) which are standard evaluations for IVD devices to demonstrate their analytical performance.
- Predicate Device: The mention of a "Predicate Device(s)" (K083867; Access Sex Hormone Binding Globulin Reagent) is common in regulatory submissions for IVDs, indicating a comparison to a previously cleared device of the same type.
All these factors strongly indicate that the Access SHBG assay is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Access SHBG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Sex Hormone Binding Globulin levels in human serum and plasma using the Access Immunoassay Systems. The Access SHBG assay is indicated for use in the assessment of androgen disorders.
Product codes (comma separated list FDA assigned to the subject device)
CDZ
Device Description
The Access SHBG assay is a sequential two-site immunoenzymatic ("sandwich") assay. The Access SHBG assay consists of the reagent pack, calibrators and QCs. Other items needed to run the assay include substrate and wash buffer. The Access SHBG assay reagent pack, Access SHBG assay calibrators, Access SHBG QCs, 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
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Method comparison study: A total of one hundred and fifty-one (151) samples were evaluated. The results of the method comparison study met the acceptance criteria of R2 ≥ 0.95 with a slope equal to 1.00 ± 0.09 and supports the equivalence of the Access SHBG assay on Dxl 9000 Access Immunoassay Analyzer to the Access SHBG on the Access 2 instrument.
Precision study: Repeatability (within-run) and within-laboratory (total) precision studies. The study was run on three Dxl 9000 Access Immunoassay Analyzer systems, three reagent lots, and three calibrator lots. Five (5) serum samples with varying SHBG concentrations, were assayed in duplicate with two runs per day, over 20 days.
Linearity study: A verification study evaluated the linearity of the Access SHBG assay on the Dxl 9000 Access Immunoassay Analyzer. A native sample at the low end of the measuring range and a high sample created by spiking with SHBG antigen were used. Seven mixtures were also tested. The Access SHBG assay is linear throughout the analytical measuring interval of 0.33 nmol/L - 200 nmol/L.
LoB, LoD, and LoQ studies: Limit of Blank (LoB), Limit of Detection (LoD), and Limit of Quantitation (LoQ) studies. Four distinct blank samples were used for LoB. Six to seven samples with low SHBG levels were measured for LoD. Twelve to thirteen serum samples with low SHBG levels were measured for LoQ.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Method Comparison:
N: 151
Concentration Range (nmol/L): 0.63 - 235
Slope: 1.01
Slope 95% CI: 1.00-1.03
Intercept: -0.019
Intercept 95% CI: -0.46 - 0.29
Correlation Coefficient R: 1.00
R2: 0.99
Precision (Repeatability and Within-Laboratory (Total)):
Sample 1: Mean 0.82 nmol/L, Repeatability SD 0.02, %CV 2.3; Within-Laboratory (Total) SD 0.04, %CV 4.6
Sample 2: Mean 18 nmol/L, Repeatability SD 0.3, %CV 1.4; Within-Laboratory (Total) SD 0.5, %CV 2.7
Sample 3: Mean 47 nmol/L, Repeatability SD 0.7, %CV 1.6; Within-Laboratory (Total) SD 1.3, %CV 2.7
Sample 4: Mean 90 nmol/L, Repeatability SD 1.4, %CV 1.5; Within-Laboratory (Total) SD 2.6, %CV 2.9
Sample 5: Mean 198 nmol/L, Repeatability SD 3.0, %CV 1.5; Within-Laboratory (Total) SD 5.1, %CV 2.6
LoB, LoD, and LoQ:
Maximum observed LoB: 0.005 nmol/L
Maximum observed LoD: 0.01 nmol/L
Maximum observed LoQ: 0.06 nmol/L
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1680 Testosterone test system.
(a)
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.(b)
Classification. Class I.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 8, 2024
Beckman Coulter Inc. Kate Oelberg Senior Staff Quality and Regulatory Affairs 1000 Lake Hazeltine Drive Chaska, Minnesota 55318
Re: K233480
Trade/Device Name: Access SHBG Regulation Number: 21 CFR 862.1680 Regulation Name: Testosterone Test System Regulatory Class: Class I, reserved Product Code: CDZ Dated: December 14, 2023 Received: December 14, 2023
Dear Kate Oelberg:
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.
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).
1
2
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 820.70) 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.
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-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,
Paula V. Caposino -S
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
2
Indications for Use
510(k) Number (if known) K233480
Device Name Access SHBG
Indications for Use (Describe)
The Access SHBG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Sex Hormone Binding Globulin levels in human serum and plasma using the Access Immunoassay Systems. The Access SHBG assay is indicated for use in the assessment of androgen disorders.
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) |
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
510 (k) Summary This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
510(k) Number K233480
Date Prepared: 1/30/2024
Submitted Bv:
Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318
Primary Contact:
Kate Oelberg Senior Staff Quality and Regulatory Affairs Phone: (612) 431-7315 Email: kmoelberg@beckman.com
Alternate Contact:
Kuljeet Kaur Senior Manager, Regulatory Affairs Phone: (952) 368-7816 Email: kkaur@beckman.com
Device Name
Common Name: Access SHBG Trade Name: Access SHBG Classification Name: Alkaline phosphatase or isoenzymes test system. Classification Code: CDZ (Class 1) - Radioimmunoassay, Testosterones and Dihydrotestosterone Classification Requlation: 21 CFR 862.1680
Predicate Device Device Name: Access Sex Hormone Binding Globulin Reagent 510(k) Numbers: K083867
Device Description
The Access SHBG assay is a sequential two-site immunoenzymatic ("sandwich") assay. The Access SHBG assay consists of the reagent pack, calibrators and QCs. Other items needed to run the assay include substrate and wash buffer. The Access SHBG assay reagent pack, Access SHBG assay calibrators, Access SHBG QCs, along with the UniCel Dxl Wash Buffer II are designed for use with the Dxl 9000 Access Immunoassay Analyzer in a clinical laboratory setting.
4
Intended Use
The Access SHBG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Sex Hormone Binding Globulin levels in human serum and plasma using the Access Immunoassay Systems.
Indications for Use
The Access SHBG assay is indicated for use in the assessment of androgen disorders.
| Parameter | Access Sex Hormone Binding Globulin
Reagent Access UniCel Dxl 800
Immunoassay System (Predicate) | Access SHBG on Dxl 9000
Access Immunoassay System |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| Intended use | The Access SHBG assay is a
paramagnetic particle, chemiluminescent
immunoassay for the quantitative
determination of Sex Hormone Binding
Globulin levels in human serum and
plasma using the Access Immunoassay
Systems. | Same |
| Technology | Two-step immunoenzymatic assay | Same |
| Format | Chemiluminescent | Same |
| Calibration | Utilizes a stored calibration curve | Same |
| Sample Type | Serum and lithium heparin plasma | Same |
| Measuring
Range | Approximately 0.33 - 200 nmol/L | Same |
| Instrument | Access UniCel Dxl 800 Immunoassay
System | Dxl 9000 Access Immunoassay
Analyzer |
| Substrate | Access Substrate | Lumi-Phos Pro Substrate |
Comparison of Technological Characteristics to the Predicate
Standard/Guidance Document Referenced (if applicable):
CLSI EP05-A3: Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline – Third Edition
CLSI EP06-2nd Edition : Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline
5
CLSI EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures: Approved Guideline - Second Edition CLSI EP09c 30 Edition: Measurement Procedure Comparison and Bias Estimation Using Patient Samples: Third Edition
Summary of Studies
Method Comparison: Method comparison study was performed to compare the Access SHBG 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 fifty-one (151) samples were evaluated in the method comparison study. The results of the method comparison study met the acceptance criteria of R2 ≥ 0.95 with a slope equal to 1.00 ± 0.09 and supports the equivalence of the Access SHBG assay on Dxl 9000 Access Immunoassay Analyzer to the Access SHBG on the Access 2 instrument.
| N | Concentration
Range*
(nmol/L) | Slope | Slope
95% CI | Intercept | Intercept
95% CI | Correlation
Coefficient
R | R2 |
|-----|-------------------------------------|-------|-----------------|-----------|---------------------|---------------------------------|------|
| 151 | 0.63 - 235 | 1.01 | 1.00-1.03 | -0.019 | -0.46 - 0.29 | 1.00 | 0.99 |
*Range is Access 2 values
lmprecision: 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 Analyzer systems, three reagent lots, and three calibrator lots. Five (5) serum samples with varying SHBG concentrations, were assayed in duplicate with two runs per day, over 20 days. The assay was designed to have within-laboratory imprecision as listed below:
≤ 0.14 nmol/L SD at concentrations ≤ 2 nmol/L
≤ 7.0% CV at concentrations > 2 nmol/L
The results from a representative lot are as follows:
| Concentration (nmol/L) | | | Repeatability
(Within-run) | | Between-run | | Between-day | | Within-
Laboratory (Total) | |
|------------------------|----|------|-------------------------------|-----|-------------|-----|-------------|-----|-------------------------------|-----|
| Sample | N | Mean | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Sample 1 | 80 | 0.82 | 0.02 | 2.3 | 0.01 | 1.5 | 0.03 | 3.7 | 0.04 | 4.6 |
| Sample 2 | 80 | 18 | 0.3 | 1.4 | 0.2 | 1.4 | 0.4 | 1.9 | 0.5 | 2.7 |
| Sample 3 | 80 | 47 | 0.7 | 1.6 | 0.6 | 1.6 | 0.8 | 1.8 | 1.3 | 2.7 |
6
Sample 4 | 80 | 90 | 1.4 | 1.5 | 1.4 | 1.5 | 1.7 | 1.9 | 2.6 | 2.9 |
---|---|---|---|---|---|---|---|---|---|---|
Sample 5 | 80 | 198 | 3.0 | 1.5 | 3.4 | 1.5 | 2.3 | 1.2 | 5.1 | 2.6 |
Limearity: A verification study was performed to evaluate the linearity of the Access SHBG 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". A native sample was obtained at the low end of the assay's measuring range. A high sample was created by spiking a low serum sample with SHBG antigen to achieve a concentration at or above the highest calibrator. In addition to the high and low SHBG concentration samples, seven mixtures were tested in this study. The Access SHBG assay is linear on the Dxl 9000 Access Immunoassay Analyzer throughout the analytical measuring interval of 0.33 nmol/L - 200 nmol/L.
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 distinct blank samples (calibrator matrix were used for the LoB determination. For estimation of LoD, six to seven samples containing low levels of SHBG analyte were measured. For estimation of LoQ, 12-13 serum samples containing low levels of SHBG analyte were measured. The LoB study included multiple reagent lots and 3 Dxl 9000 Access Immunoassay Analyzers over a minimum of 3 days. The LoQ studies included multiple reagent lots and 3 Dxl 9000 Access Immunoassay Analyzers over a minimum of 5 days. The maximum observed results for LoB for Access SHBG assay is 0.005 nmol/L, LoD is 0.01 nmol/L and LoQ is 0.06 nmol/L on Dxl 9000 Access Immunoassay Analyzer.
Other claims: The claims for the analytical specificity and reference intervals are being transferred from file K083867.
Substantial Equivalence Comparison Conclusion
Beckman Coulter's Access SHBG on the Dxl 9000 Access Immunoassay Analyzer is substantially equivalent to the Access Sex Hormone Binding Globulin Reagent 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.