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 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 patient CA 15-3 antigen concentrations should be used in conjunction with other clinical methods for monitoring breast cancer.

The Access BR Monitor Calibrators are intended to calibrate the Access BR Monitor assay for the quantitative determination of CA 15-3 antigen levels in human serum and plasma using the Access Immunoassay Systems.

Device Description

The Access BR Monitor assay and the Access Immunoassay Analyzers comprise the Access Immunoassay Systems for the quantitative determination of CA 15-3 antigen levels in human serum and plasma.

AI/ML Overview

Acceptance Criteria and Device Performance Study for Access® BR Monitor Assay (K072612)

This submission describes the modified Access® BR Monitor assay, an immunoassay for the quantitative determination of CA 15-3 antigen levels in human serum and plasma. The study focuses on demonstrating substantial equivalence to the previously cleared Access® BR Monitor assay (K033036) by verifying that the modified device meets specified acceptance criteria, particularly concerning imprecision.

1. Table of Acceptance Criteria and Reported Device Performance

Attribute	Acceptance Criteria (Modified Device)	Reported Device Performance (Modified Device)
Intended Use	For the quantitative determination of CA 15-3 antigen levels in human serum and plasma.	For the quantitative determination of CA 15-3 antigen levels in human serum and plasma. (Meets Acceptance Criteria)
Assay principles	Is a two-site immunoenzymatic ("sandwich") assay.	Is a two-site immunoenzymatic ("sandwich") assay. (Meets Acceptance Criteria)
Solid Support	Paramagnetic particles.	Paramagnetic particles. (Meets Acceptance Criteria)
Detection System	Chemiluminescent substrate.	Chemiluminescent substrate. (Meets Acceptance Criteria)
Calibrator	Six levels of CA 15-3 antigen at levels of zero and approximately 10, 50, 100, 500, and 1000 U/mL in a buffered BSA matrix.	Six levels of CA 15-3 antigen at levels of zero and approximately 10, 50, 100, 500, and 1000 U/mL in a buffered BSA matrix. (Meets Acceptance Criteria)
Analytical Range	0.5 - 1000 U/mL	0.5 - 1000 U/mL (Meets Acceptance Criteria)
Imprecision	≤ 10% for concentrations between 15 and 500 U/mL, and ≤ 12% for concentrations greater than 500 U/mL.	Within-run imprecision: ranged from 5.1 % CV to 9.6% CV for concentrations from approximately 18 to 513 U/mL.Between-run imprecision: ranged from 3.1% CV to 5.8% CV.Total imprecision: ranged from 7.7% CV to 10.8% CV.

Assessment of Imprecision Performance:

The reported total imprecision (7.7% - 10.8% CV) falls largely within the acceptance criteria of ≤ 10% for concentrations between 15 and 500 U/mL.
The statement "Total imprecision ranged from 7.7% CV to 10.8% CV" suggests that within the tested range (18 to 513 U/mL), there might be some values slightly exceeding 10% CV, likely towards the upper end of the 500 U/mL range or slightly above it. The acceptance criteria for concentrations greater than 500 U/mL is ≤ 12%. The summary states that "Imprecision above 500 U/mL was the only performance characteristic revised," implying the device does meet the ≤ 12% criterion for concentrations > 500 U/mL, even if not explicitly detailed in the reported values. The overall conclusion states that the modification to imprecision above 500 U/mL "was not found to impact the safety and efficacy of the device."

2. Sample size used for the test set and the data provenance

The document provides a "Summary of Precision Study" which states:

Within-run assay imprecision was tested for concentrations from approximately 18 to 513 U/mL.
Data Provenance: Not explicitly stated, but clinical precision studies for diagnostic devices are typically conducted in a controlled laboratory setting (e.g., in-house or contract research organization). It's reasonable to infer this was a prospective study designed to assess the performance of the modified device. The country of origin is not specified.

The exact number of samples (individual patient samples or spiked control samples) used to generate these imprecision ranges is not provided. Usually, imprecision studies involve running multiple replicates of control samples at different concentrations across various runs and days.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is an in-vitro diagnostic (IVD) device for quantitative antigen determination, not a device requiring human expert interpretation of images or other subjective data for ground truth establishment. The "ground truth" for precision studies relies on the known or reference values of the control materials used.

4. Adjudication method for the test set

Not applicable. As described above, this is an IVD device for quantitative measurement. There is no subjective interpretation requiring adjudication among experts.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an IVD immunoassay, not an AI-assisted diagnostic tool requiring human reader studies or MRMC analyses.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, the precision study evaluates the performance of the Access® BR Monitor assay as a standalone algorithm/device. The results (CV percentages) reflect the inherent performance of the instrument and reagents in measuring CA 15-3 antigen levels without human subjective interpretation.

7. The type of ground truth used

The ground truth for the imprecision study is based on the known or reference concentrations of the control samples used. These control samples are typically manufactured to contain specific, verified concentrations of the CA 15-3 antigen.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI-based device that requires a distinct "training set" in the conventional sense. The device's operational parameters (e.g., reagent formulation, calibration curves) are established through manufacturing and assay development processes, not through a 'training set' of data in the AI context.

9. How the ground truth for the training set was established

Not applicable, as explained in point 8. The "ground truth" for establishing the assay's operational characteristics would stem from analytical characterization during development, using reference materials and established analytical methods.

Summary

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510(k) Summary

007 26 2007

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.

The assigned 510(k) number is	K072612
Applicant:	Beckman Coulter, Inc.1000 Lake Hazeltine DriveChaska, MN 55318
Contact person:	Rachelle Parsons, RACSr. Regulatory Affairs SpecialistPhone: 952.368.1227Fax: 952.368.7610
Date prepared:	August 21, 2007
Proprietary name:	Access® BR Monitor and Access BR Monitor Calibrators onthe Access Immunoassay Systems
Common name:	Immunoassay for the determination of CA 15-3 antigen
Product classification:	Class II
Product code:	MOI, JIT
Predicate device:	Access BR Monitor Assay - K033036
Device description:	The Access BR Monitor assay and the AccessImmunoassay Analyzers comprise the Access ImmunoassaySystems for the quantitative determination of CA 15-3antigen levels in human serum and plasma.
Intended use:	The Access BR Monitor assay is a paramagnetic particle,chemiluminescent immunoassay for the quantitativedetermination of CA 15-3 antigen levels in human serum andplasma using the Access Immunoassay Systems.

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Comparison of Technological Characteristics

Attribute	Access BR Monitor	Access BR Monitor(with modification)
Intended Use	For the quantitativedetermination of CA 15-3antigen levels in human serumand plasma.	For the quantitativedetermination of CA 15-3antigen levels in human serumand plasma.
Assay principles	The Access BR Monitor assayis a two-site immunoenzymatic("sandwich") assay.	The Access BR Monitor assayis a two-site immunoenzymatic("sandwich") assay.
Solid Support	Paramagnetic particles.	Paramagnetic particles.
Detection System	Chemiluminescent substrate.	Chemiluminescent substrate.
Calibrator	Six levelsCA 15-3 antigen at levels ofzero and approximately 10, 50,100, 500, and 1000 U/mL in abuffered BSA matrix.	Six levelsCA 15-3 antigen at levels ofzero and approximately 10, 50,100, 500, and 1000 U/mL in abuffered BSA matrix.
Analytical Range	0.5 - 1000 U/mL	0.5 - 1000 U/mL
Imprecision	This assay exhibits totalimprecision of less than 10%across the assay range.	This assay exhibits totalimprecision of ≤ 10% forconcentrations between 15 and500 U/mL, and ≤ 12% forconcentrations greater than500 U/mL.

Summary of Precision Study

Imprecision: Within-run assay imprecision was tested for concentrations from approximately 18 to 513 U/mL. The within-run imprecision ranged from 5.1 % CV to 9.6% CV. Between-run assay imprecision ranged from 3.1% CV to 5.8% CV. Total imprecision ranged from 7.7% CV to 10.8% CV.

Conclusion

Imprecision above 500 U/mL was the only performance characteristic revised in the Access BR Monitor assay and was not found to impact the safety and efficacy of the device. The modified Access® BR Monitor assay is substantially equivalent to the previously cleared Access® BR Monitor assay.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A." arranged in a circle around the symbol. The caduceus is depicted with three wavy lines instead of snakes.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 2 6 2007

Beckman Coulter, Inc. c/o Ms. Rachelle Parsons Sr. Regulatory Specialist - RAC 1000 Lake Hazeltine Drive Chaska, MN 55318

Re: K072612

Trade/Device Name: Access® BR Monitor and Access BR Monitor Calibrators on the Access Immunoassay Systems Regulation Number: 21 CFR 866.6010 Regulation Name: Tumor-associated antigen immunological test system Regulatory Class: Class II Product Code: MOI, JIT Dated: September 14, 2007 Received: September 17, 2007

Dear Ms. Parsons:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The

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FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97), For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Robert L. Booted

Robert L. Becker, Jr., M.D., Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indication for Use

510(k) Number (if known): K072612

Device Name:

BR Monitor and BR Monitor Calibrators on the Access® Immunoassay Systems

Indication For Use:

سك - Prescription Use (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use ._ (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

ia m Chan

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K072612

Regulation Number and Section

§ 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.