(90 days)
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No
The summary describes a standard immunoassay system for measuring a specific biomarker and does not mention any AI or ML components in its description, performance studies, or key metrics.
No
This device is an immunoassay system designed to measure CA 15-3 antigen levels, which aids in monitoring breast cancer patients, not treating them.
Yes
The device is described as a "chemiluminescent immunoassay for the quantitative determination of CA 15-3 antigen levels in human serum and plasma" and is "indicated for use in the measurement of CA 15-3 antigen to aid in the management of breast cancer patients." This explicitly states its purpose in aiding in patient management through measurement, which aligns with the definition of a diagnostic device.
No
The device description explicitly states that the device comprises the Access BR Monitor assay, Access BR Monitor Calibrators, and the Access Immunoassay analyzers (specifically the Dxl 9000 Access Immunoassay Analyzer). These are physical components (reagents, calibrators, and an analyzer) and not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of CA 15-3 antigen levels in human serum and plasma" and is "indicated for use in the measurement of CA 15-3 antigen to aid in the management of breast cancer patients." This involves testing a sample taken from the human body (serum and plasma) outside of the body (in vitro) to provide information for medical purposes (managing breast cancer patients).
- Device Description: The description details an "immunoassay" which is a common type of in vitro diagnostic test. It also mentions "Access BR Monitor Calibrators," which are used to calibrate the assay, a typical component of an IVD system.
- Performance Studies: The performance studies described (Method Comparison, Imprecision, Linearity, Limit of Blank, Limit of Detection, Limit of Quantitation) are all standard types of studies performed to validate the performance of an in vitro diagnostic assay.
- Predicate Devices: The mention of predicate devices with K numbers (K072612, Access BR Monitor; K033036, Access BR Monitor) indicates that this device is being compared to previously cleared IVD devices.
All of these points strongly support the classification of this device as an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Access BR Monitor assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CA 15-3 antigen levels in human serum and plasma (heparin) using the Access Immunoassay Systems. This device is indicated for use in the measurement of CA 15-3 antigen to aid in the management of breast cancer patients. Serial testing for CA 15-3 antigen concentrations should be used in conjunction with other clinical methods for monitoring breast cancer.
Product codes
MOI
Device Description
The Access BR Monitor assay, Access BR Monitor Calibrators, and the Access Immunoassay analyzers comprise the Dxl 9000 Access Immunoassay Amalyzer for the quantitative determination of CA 15-3 antigen levels in human serum and plasma (heparin) using the Dxl 9000 Access Immunoassay Analyzer.
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 study based on CLSI EP09c, 3rd Edition20 using Passing-Bablok regression and Pearson's correlation compared the Access 2 Immunoassay System and the Dxl 9000 Access Immunoassay Analyzer. N=163, Concentration Range*= 0.55 - 990 (U/mL), Slope=0.95, Slope 95% Cl=0.94 - 0.96, Intercept=0.70, Intercept 95% Cl=0.31 - 1.4, Correlation Coefficient R=1.00.
Imprecision: The within-laboratory imprecision is less than or equal to 1.5 U/mL SD at concentrations less than or equal to 15 U/mL and less than or equal to 10.0% CV at concentrations greater than or equal to 15 u/mL. The results met the acceptance criteria and indicated that the imprecision of the Access BR Monitor assay is acceptable on Dxl 9000 Access Immunoassay Analyzer.
Linearity: The results of this study met the acceptance criterion, indicating that the Access BR Monitor assay is linear on the Dxl 9000 Access Immunoassay Analyzer throughout the analytical measuring interval (0.8 – 1,000 U/mL).
Limit of Blank (LoB): The LoB estimate for BR Monitor was determined to be 0.1 U/mL on Dxl 9000 Immunoassay Analyzer. The results of this study demonstrate that the BR Monitor assay met the acceptance criteria of 0.4 U/mL on Dxl 9000 Access Immunoassay Analyzer.
Limit of Detection (LoD): The LoD estimate for the BR Monitor assay is 0.3 U/mL on Dxl 9000 Immunoassay Analyzer. The results of this study demonstrate that the BR Monitor assay met the acceptance criteria of 0.5 U/mL on Dxl 9000 Access Immunoassay Analyzer.
Limit of Quantitation (LoQ): The results provided demonstrate the 20% CV LoQ estimate for the BR Monitor assay to be 0.3 U/mL. The results provided demonstrate the LoQ at 20% within-laboratory imprecision estimate of the BR Monitor assay to be 0.8 U/mL on the Dxl 9000 Immunoassay Analyzer.
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 866.6010 Tumor-associated antigen immunological test system.
(a)
Identification. A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.(b)
Classification. Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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.
May 9, 2024
Beckman Coulter, Inc. Kate Oelberg Senior Staff Quality and Regulatory Affairs 1000 Lake Hazeltine Drive Chaska, Minnesota 55318
Re: K240403
Trade/Device Name: Access BR Monitor Regulation Number: 21 CFR 866.6010 Regulation Name: Tumor-Associated Antigen Immunological Test System Regulatory Class: Class II Product Code: MOI Dated: February 9, 2024 Received: February 9, 2024
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 (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"
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(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 OS 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.
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.
Ying Mao -S
Ying Mao, Ph.D. Branch Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
K240403 Device Name
Access BR Monitor
Indications for Use (Describe)
The Access BR Monitor assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CA 15-3 antigen levels in human serum and plasma (heparin) using the Access Immunoasay Systems. This device is indicated for use in the measurement of CA 15-3 antigen to aid in the management of breast cancer patients. Serial testing for CA 15-3 antigen concentrations should be used in conjunction with other clinical methods for monitoring breast cancer.
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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Image /page/3/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red oval shape with two white curved lines inside, placed to the left of the company name. The text "BECKMAN" is stacked on top of "COULTER" in a bold, sans-serif font.
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: K240403
Date Prepared: April 29, 2024
Submitted By: 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, Regulatory Affairs Senior Manager Email: kkaur@beckman.com Office Phone: (952) 465-1914
Device Name:
Common Name: Immunoassay for the determination of CA 15-3 antigen Trade Name: Access BR Monitor Reagents Classification Name: Tumor-associated antigen immunological test system Classification Regulation: (21 CFR 866.6010)
Predicate Device: Device Name: Access BR Monitor 510(k) Numbers: K072612, K033036
Device Description
The Access BR Monitor assay, Access BR Monitor Calibrators, and the Access Immunoassay analyzers comprise the Dxl 9000 Access Immunoassay Amalyzer for the quantitative determination of CA 15-3 antigen levels in human serum and plasma (heparin) using the Dxl 9000 Access Immunoassay Analyzer.
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Intended Use
The Access BR Monitor assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CA 15-3 antigen levels in human serum and plasma (heparin) using the Access Immunoassay Systems. This device is indicated for use in the measurement of CA 15-3 antigen to aid in the management of breast cancer patients. Serial testing for CA 15-3 antigen concentrations should be used in conjunction with other clinical methods for monitoring breast cancer.
| Parameter | Access BR Monitor on Access 2
Immunoassay System Predicate -
K072612 | Access BR Monitor on Dxl
9000 Access Immunoassay
Analyzer |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| Intended use | The Access BR Monitor assay is a
paramagnetic particle,
chemiluminescent immunoassay for
the quantitative determination of CA
15-3 antigen levels in human serum
and plasma (heparin) using the Access
Immunoassay Systems. This device is
indicated for use in the measurement
of CA 15-3 antigen to aid in the
management of breast cancer patients.
Serial testing for CA 15-3 antigen
concentrations should be used in
conjunction with other clinical methods
for monitoring breast cancer. | Same |
| Analyte
Measured | CA 15-3 antigen levels in human
serum and plasma (heparin) | Same |
| Technology | Two-site immunoenzymatic
("sandwich") assay | Same |
| Format | Chemiluminescent | Same |
| Method | Automated | Same |
| Calibration | Utilizes a stored calibration curve | Same |
| Measuring Range | 0.5 – 1,000 U/mL | 0.8 - 1,000 U/mL |
| Substrate | Access Substrate | Lumi-Phos PRO Substrate |
| Instrument | Access 2 Immunoassay system; | Dxl 9000 Access Immunoassay
Analyzer |
Comparison of Technological Characteristics to the Predicate
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Standard/Guidance Document Referenced (if applicable):
These standards can be copied or found from requlatory submission reports:
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
CLSI EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline - Second Edition
CLSI EP09c 3rd Edition: Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Third Edition
Summary of Studies
Method Comparison: A study based on CLSI EP09c, 3rd Edition20 using Passing-Bablok regression and Pearson's correlation compared the Access 2 Immunoassay System and the Dxl 9000 Access Immunoassay Analyzer.
| N | Concentration
Range*
(U/mL) | Slope | Slope
95% Cl | Intercept | Intercept
95% Cl | Correlation
Coefficient R |
|-----|-----------------------------------|-------|-----------------|-----------|---------------------|------------------------------|
| 163 | 0.55 - 990 | 0.95 | 0.94 - 0.96 | 0.70 | 0.31 - 1.4 | 1.00 |
*Range is Access 2 values
Imprecision: The within-laboratory imprecision is ≤ 1.5 U/mL SD at concentrations ≤ 15 U/mL and ≤ 10.0% CV at concentrations ≥ 15 u/mL. The results met the acceptance criteria and indicated that the imprecision of the Access BR Monitor assay is acceptable on Dxl 9000 Access Immunoassay Analyzer.
| Concentration (U/mL) | | Repeatability
(Within-run) | | Between-run | | Between-day | | Within- Laboratory
(Total) | | |
|----------------------|-----|-------------------------------|------|-------------|------|-------------|--------|-------------------------------|------|-----|
| Sample | N | Mean | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Sample 1 | 126 | 4.2 | 0.1 | 2.0 | 0.1 | 2.8 | 0.0001 | 0.0 | 0.1 | 3.4 |
| Sample 2 | 126 | 19 | 0.3 | 1.6 | 0.4 | 2.0 | 0.2 | 1.2 | 0.5 | 2.9 |
| Sample 3 | 120 | 34 | 0.8 | 2.2 | 0.6 | 1.7 | 0.6 | 1.6 | 1.1 | 3.2 |
| Sample 4 | 120 | 79 | 1.8 | 2.3 | 1.5 | 2.0 | 0.0 | 0.0 | 2.4 | 3.0 |
| Sample 5 | 120 | 105 | 1.9 | 1.8 | 2.4 | 2.3 | 0.0 | 0.0 | 3.1 | 3.0 |
| Sample 6 | 120 | 425 | 9.2 | 2.2 | 9.8 | 2.3 | 0.0 | 0.0 | 13.4 | 3.2 |
| Sample 7 | 120 | 825 | 26.3 | 3.2 | 19.9 | 2.4 | 1.8 | 0.2 | 33.0 | 4.0 |
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Linearity: The results of this study met the acceptance criterion, indicating that the Access BR Monitor assay is linear on the Dxl 9000 Access Immunoassay Analyzer throughout the analytical measuring interval (0.8 – 1,000 U/mL).
Limit of Blank (LoB): The LoB estimate for BR Monitor was determined to be 0.1 U/mL on Dxl 9000 Immunoassay Analyzer. The results of this study demonstrate that the BR Monitor assay met the acceptance criteria of 0.4 U/mL on Dxl 9000 Access Immunoassay Analyzer.
Limit of Detection (LoD): The LoD estimate for the BR Monitor assay is 0.3 U/mL on Dxl 9000 Immunoassay Analyzer. The results of this study demonstrate that the BR Monitor assay met the acceptance criteria of 0.5 U/mL on Dxl 9000 Access Immunoassay Analyzer.
Limit of Quantitation (LoQ): The results provided demonstrate the 20% CV LoQ estimate for the BR Monitor assay to be 0.3 U/mL. The results provided demonstrate the LoQ at 20% within-laboratory imprecision estimate of the BR Monitor assay to be 0.8 U/mL on the Dxl 9000 Immunoassay Analyzer.
Conclusion: Beckman Coulter's Access BR Monitor on the Dxl 9000 Access Immunoassay Analyzer is substantially equivalent to the Access BR Monitor on the Access 2 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.