(350 days)
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No
The summary describes a standard immunoassay for measuring a biomarker and does not mention any AI or ML components.
No
The device is an in vitro diagnostic assay used for quantitative measurement of CA 15-3 values to aid in the management of breast cancer patients, which is a diagnostic purpose, not a therapeutic one.
Yes
The device is described as an "assay" for "quantitative measurement" of CA 15-3 values to "aid in the management of breast cancer patients," which clearly indicates its use for diagnosis and monitoring of a disease. It also mentions "serial testing" to be "used in conjunction with other clinical methods for monitoring breast cancer."
No
The device description clearly states it is a microparticle enzyme immunoassay (MEIA) for use on the AxSYM System, which is a laboratory instrument. This indicates it is an in vitro diagnostic (IVD) assay that requires specific hardware (the AxSYM System) to function, not a standalone software application.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative measurement of CA 15-3 assay values in human serum and plasma (EDTA)". This indicates it's used to analyze biological samples in vitro (outside the body).
- Device Description: The description confirms it's a "microparticle enzyme immunoassay for the quantitative measurement of CA 15-3 assay values in human serum and EDTA plasma". This further reinforces its use in analyzing biological fluids.
- Input Imaging Modality: The "Not Applicable (In vitro diagnostic assay)" entry directly identifies it as an IVD.
- Anatomical Site: The "Not Applicable (In vitro diagnostic assay)" entry also indicates it's an IVD.
The core function of the device is to perform a test on biological samples (serum and plasma) to obtain a quantitative measurement of a specific marker (CA 15-3) to aid in the management of a disease (breast cancer). This is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AxSYM® CA 15-3" assay is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative measurement of CA 15-3 assay values in human serum and plasma (EDTA) to aid in the management of breast cancer patients. Serial testing for patient CA 15-3 assay values should be used in conjunction with other clinical methods for monitoring breast cancer.
Product codes
MOI
Device Description
AxSYM CA 15-3 is a microparticle enzyme immunoassay for the quantitative measurement of CA 15-3 assay values in human serum and EDTA plasma on the AxSYM System. AxSYM CA 15-3 employs Abbott Calibrators and Controls.
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
A linear regression analysis between these two assays, using 560 specimens with AxSYM CA 15-3 assay values ranging from 4.0 to 248.7 U/mL, yielded a correlation coefficient of 0.888, slope of 0.67, and y-intercept of 4.2 U/mL.
Receiver Operator Characteristic (ROC) analyses on 160 apparently healthy females plus 30 benign breast patients vs. 228 malignant breast patients gave essentially equivalent areas under the curve of 0.69 for AxSYM CA 15-3 and 0.70 for TRUQUANT BR RIA.
Seventy nine stage II and stage III breast cancer patients were evaluated in a blinded study using the AxSYM CA 15-3 assay and the TRUQUANT BR RIA. 359 specimens from 77 of the evaluable patients gave a concordance (agreement) between the two assays of 91% at their respective reference values.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A linear regression analysis between these two assays, using 560 specimens with AxSYM CA 15-3 assay values ranging from 4.0 to 248.7 U/mL, yielded a correlation coefficient of 0.888, slope of 0.67, and y-intercept of 4.2 U/mL. The dynamic range of AxSYM CA 15-3 is 0 - 250 U/mL with an analytical sensitivity of 0.3 U/mL. The dynamic range of TRUQUANT BR RIA is 0 - 200 U/mL with an analytical sensitivity of 7.0 U/mL. Receiver Operator Characteristic (ROC) analyses on 160 apparently healthy females plus 30 benign breast patients vs. 228 malignant breast patients gave essentially equivalent areas under the curve of 0.69 for AxSYM CA 15-3 and 0.70 for TRUQUANT BR RIA. Serial tracking data on 24 malignant breast patients showed comparable trending results for both assays.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
At the claimed reference values for the assays (31.3 U/mL for AxSYM CA 15-3 and 37.7 U/mL for TRUQUANT BR RIA), when using values obtained within 6 months of relapse, similar sensitivities of 54% (95% CI=25-81) and 62% (95% CI=32-86) and specificities of 94% (95% CI=85-99) and 91% (95% CI=80-97) were obtained for AxSYM CA 15-3 and TRUQUANT BR RIA, respectively.
Predicate Device(s)
BIOMIRA Diagnostics Inc. TRUQUANT® BR™ RIA
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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SEP 1 5 1957
510(k) SUMMARY AxSYM®CA 15-3™
SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING A SUBSTANTIALLY EQUIVALENT DETERMINATION
The following information as presented in the Premarket Notification [510(k)] for AxSYM CA 15-3 constitutes data supporting a substantially equivalent determination.
AxSYM CA 15-3 is a microparticle enzyme immunoassay for the quantitative measurement of CA 15-3 assay values in human serum and EDTA plasma on the AxSYM System. AxSYM CA 15-3 employs Abbott Calibrators and Controls.
Substantial equivalence has been demonstrated between the Abbott AxSYM® CA 15-3" assay and the BIOMIRA Diagnostics Inc. TRUQUANT® BR™ RIA assays are intended to be used as an aid in the management of stage II and stage III breast cancer patients. A linear regression analysis between these two assays, using 560 specimens with AxSYM CA 15-3 assay values ranging from 4.0 to 248.7 U/mL, yielded a correlation coefficient of 0.888, slope of 0.67, and y-intercept of 4.2 U/mL. The dynamic range of AxSYM CA 15-3 is 0 - 250 U/mL with an analytical sensitivity of 0.3 U/mL. The dynamic range of TRUQUANT BR RIA is 0 - 200 U/mL with an analytical sensitivity of 7.0 U/mL. Receiver Operator Characteristic (ROC) analyses on 160 apparently healthy females plus 30 benign breast patients vs. 228 malignant breast patients gave essentially equivalent areas under the curve of 0.69 for AxSYM CA 15-3 and 0.70 for TRUQUANT BR RIA. Serial tracking data on 24 malignant breast patients showed comparable trending results for both assays.
Seventy nine stage II and stage III breast cancer patients were evaluated in a blinded study using the AxSYM CA 15-3 assay and the TRUQUANT BR RIA. 359 specimens from 77 of the evaluable patients gave a concordance (agreement) between the two assays of 91% at their respective reference values. At the claimed reference values for the assays (31.3 U/mL for AxSYM CA 15-3 and 37.7 U/mL for TRUQUANT BR RIA), when using values obtained within 6 months of relapse, similar sensitivities of 54% (95% CI=25-81) and 62% (95% CI=32-86) and specificities of 94% (95% CI=85-99) and 91% (95% CI=80-97) were obtained for AxSYM CA 15-3 and TRUQUANT BR RIA, respectively.
In conclusion, these data demonstrate that the Abbott AxSYM CA 15-3 assay is as safe and effective as, and is substantially equivalent to the BIOMIRA Diagnostics Inc. TRUQUANT BR RIA assay.
Prepared and Submitted September 26, 1996 (edited September 10, 1997) by:
Joy C. Sonsalla 200 Abbott Park Road Abbott Laboratories Abbott Park, IL 60064
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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's commitment to health, human services, and the pursuit of excellence. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle symbol.
Joy C. Sonsalla Regulatory Affairs Section Leader ADD Regulatory Affairs D96V6 AP31 200 Abbott Park Road Abbott Park, IL 60064-3537 SEP | 5 |997
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Re : K963926/5002 Trade Name: Abbott AxSYM® CA 15-3TM Regulatory Class: II Product Code: MOI Dated: July 15, 1997 Received: July 16, 1997
Dear Ms. Sonsalla:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The qeneral controls provisions of the Act include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Y Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K 96 3926
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The AxSYM® CA 15-3" assay is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative measurement of CA 15-3 assay values in human serum and plasma (EDTA) to aid in the management of breast cancer patients. Serial testing for patient CA 15-3 assay values should be used in conjunction with other clinical methods for monitoring breast cancer.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Liter
(Division Sign-Off)
OR
Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use
(Optional Format 1-2-96)
AxSYM CA 15-3 510(k) September 1996 ax 153510 doc