(39 days)
Not Found
No
The summary describes a standard immunoassay for measuring a biomarker (CA 15-3) and does not mention any AI or ML components in the device description, intended use, or performance studies.
No
The device is an immunoassay for measuring CA 15-3 antigen levels, used to aid in the management and monitoring of breast cancer patients, rather than directly treating their condition.
Yes
The device is described as a "chemiluminescent immunoassay for the quantitative determination of CA 15-3 antigen levels in human serum and plasma" used to "aid in the management of breast cancer patients," which indicates its role in disease evaluation and monitoring.
No
The device is an immunoassay system, which includes both reagents (assay and calibrators) and hardware (Access Immunoassay Analyzers), 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." This involves testing biological samples in vitro (outside the body).
- Device Description: It describes an "immunoassay" system, which is a common type of IVD technology used to measure substances in biological fluids.
- Sample Type: The input is "human serum and plasma," which are biological samples.
- Purpose: The purpose is to "aid in the management of breast cancer patients" by measuring a specific marker in their blood. This is a diagnostic or monitoring function performed on a sample.
The information provided clearly aligns with the definition of an In Vitro Diagnostic device.
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.
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.
Product codes (comma separated list FDA assigned to the subject device)
MOI, JIT
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
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
§ 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
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 Drive | |
| Chaska, MN 55318 | |
| Contact person: | Rachelle Parsons, RAC |
| Sr. Regulatory Affairs Specialist | |
| Phone: 952.368.1227 | |
| Fax: 952.368.7610 | |
| Date prepared: | August 21, 2007 |
| Proprietary name: | Access® BR Monitor and Access BR Monitor Calibrators on |
| the 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 Access |
| Immunoassay Analyzers comprise the Access Immunoassay | |
| Systems for the quantitative determination of CA 15-3 | |
| antigen levels in human serum and plasma. | |
| 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. |
1
Comparison of Technological Characteristics
| Attribute | Access BR Monitor | Access BR Monitor
(with modification) |
|------------------|--------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. |
| Assay principles | The Access BR Monitor assay
is a two-site immunoenzymatic
("sandwich") assay. | The Access BR Monitor assay
is a two-site immunoenzymatic
("sandwich") assay. |
| Solid Support | Paramagnetic particles. | Paramagnetic particles. |
| Detection System | Chemiluminescent substrate. | Chemiluminescent substrate. |
| Calibrator | Six levels
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
CA 15-3 antigen at levels of
zero and approximately 10, 50,
100, 500, and 1000 U/mL in a
buffered BSA matrix. |
| Analytical Range | 0.5 - 1000 U/mL | 0.5 - 1000 U/mL |
| Imprecision | This assay exhibits total
imprecision of less than 10%
across the assay range. | This assay exhibits total
imprecision of ≤ 10% for
concentrations between 15 and
500 U/mL, and ≤ 12% for
concentrations greater than
500 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.
2
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
3
Page 2 -
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
4
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:
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.
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