(127 days)
No
The summary describes a standard immunoassay system for measuring a specific antigen. There is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies. The analysis focuses on analytical and clinical performance metrics typical of laboratory diagnostic tests.
No.
The device is an immunoassay for measuring CA 15-3 antigen levels to aid in the management of breast cancer patients by monitoring, not for direct therapy.
Yes
The device is described as a chemiluminescent immunoassay for the quantitative determination of CA 15-3 antigen levels, "indicated for use in the measurement of CA 15-3 antigen to aid in the management of breast cancer patients." This clearly states its role in diagnosis/management.
No
The device description explicitly states that the system comprises reagents, calibrators, and immunoassay analyzers (hardware). This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The Intended Use section explicitly states that the device is for the quantitative determination of CA 15-3 antigen levels in human serum and plasma. This is a classic definition of an in vitro diagnostic device, as it is used to test samples taken from the human body to provide information about a person's health.
Furthermore, the Device Description mentions "reagents, calibrators, and the Access Immunoassay Analyzers," which are components typically associated with IVD systems used for laboratory testing.
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 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.
Product codes
MOI, JIT
Device Description
The Access BR Monitor reagents, calibrators, and the Access Immunoassay Analyzers (Access, Access 2, Synchron LXi 725, and UniCel Dxl 800) comprise the Access Immunoassay Systems for the quantitative determination of CA 15-3 antigen in human serum and plasma.
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
Not Found
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
Summary of Analytical Studies:
Imprecision: Within-run assay imprecision was tested for concentrations from approximately 15 to 662 U/mL. The within-run imprecision ranged from 1.4% CV to 2.2% CV. Between-run assav imprecision ranged from 1.6% CV to 4.1% CV. Total imprecision ranged from 2.1% CV to 4.6% CV.
Analytical Sensitivity: The lowest detectable level of CA 15-3 antigen distinquishable from zero (Access BR Monitor Calibrator 0) is
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a circular graphic on the left and the company name on the right. The graphic is a black circle with two curved white lines inside, resembling a stylized eye or a double helix. The text "BECKMAN COULTER" is written in a bold, sans-serif font, with "BECKMAN" on the top line and "COULTER" on the bottom line.
FEB - 3 2004
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.
The assigned 510(k) number is:
Submitter's Name and Address
Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318 Telephone: (952) 368-1323 Fax: (952) 368-7610 Contact: Brent Taber
Date Prepared: January 23, 2004
Device Names
| Proprietary Name: | BR Monitor and BR Monitor Calibrators on the
Access® Immunoassay Systems |
|----------------------|-----------------------------------------------------------------------------|
| Common Name: | Immunological test for CA 15-3 antigen |
| Classification Name: | System, Test, Immunological, Antigen, Tumor |
Predicate Device
Abbott AxSYM® CA 15-3 TM Abbott Laboratories, Diagnostics Division Abbott Park, IL 60064
510(k) Number: K963926
Device Description
The Access BR Monitor reagents, calibrators, and the Access Immunoassay Analyzers (Access, Access 2, Synchron LXi 725, and UniCel Dxl 800) comprise the Access Immunoassay Systems for the quantitative determination of CA 15-3 antigen in human serum and plasma.
1
Image /page/1/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a stylized black circle with two curved lines inside, resembling a wave or a stylized eye. To the right of the circle, the words "BECKMAN" are stacked on top of "COULTER" in a bold, sans-serif font.
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 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.
| Attribute | AxSYM CA 15-3 | Access BR Monitor |
|---|---|---|
| Intended | ||
| Use | For the measurement of | |
| CA 15-3 antigen in human | ||
| serum and plasma | For the measurement of | |
| CA 15-3 antigen in human | ||
| serum and plasma | ||
| Assay | ||
| Principles | Utilizes the binding of CA 15-3 | |
| to a specific monoclonal | ||
| antibody in a two site | ||
| "sandwich" immunoassay; | ||
| Utilizes alkaline phosphatase | ||
| enzyme conjugated to | ||
| monoclonal antibody | Utilizes the binding of CA 15-3 | |
| to a specific monoclonal | ||
| antibody in a two site | ||
| "sandwich" immunoassay; | ||
| Utilizes alkaline phosphatase | ||
| enzyme conjugated to | ||
| monoclonal antibody | ||
| Solid | ||
| Support | Latex particles | Paramagnetic particles |
| Detection | ||
| System | Utilizes 4-Methylumbelliferyl | |
| Phosphate substrate; | ||
| Measures fluorescent | ||
| Methylumbelliferone from a | ||
| fluorescent reaction | Utilizes dioxetane-based | |
| chemiluminescent substrate; | ||
| Measures light production from | ||
| a chemiluminescent reaction | ||
| Calibrators | Liquid calibrators prepared | |
| from buffered bovine serum | ||
| albumin matrix with CA 15-3 | ||
| antigen at specified levels | Liquid calibrators prepared | |
| from buffered bovine serum | ||
| albumin matrix with CA 15-3 | ||
| antigen at specified levels |
Comparison of Technological Characteristics
Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318-1084
2
Image /page/2/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a circular symbol on the left and the company name on the right. The symbol is a black circle with a white, wave-like design inside. The company name, "BECKMAN COULTER," is written in bold, black letters, with "BECKMAN" on the top line and "COULTER" on the bottom line.
Summary of Analytical Studies
Imprecision: Within-run assay imprecision was tested for concentrations from approximately 15 to 662 U/mL. The within-run imprecision ranged from 1.4% CV to 2.2% CV. Between-run assav imprecision ranged from 1.6% CV to 4.1% CV. Total imprecision ranged from 2.1% CV to 4.6% CV.
Analytical Sensitivity: The lowest detectable level of CA 15-3 antigen distinquishable from zero (Access BR Monitor Calibrator $0) is