(91 days)
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Not Found
No
The summary describes a standard immunoassay for measuring a specific biomarker and does not mention any AI or ML components in the device description, intended use, or performance studies.
No.
This device is an immunoassay for the quantitative determination of CA 19-9 antigen levels, used to aid in the management and monitoring of pancreatic cancer patients; it is a diagnostic tool, not a therapeutic one.
Yes
The document explicitly states that the device is "indicated for use in the measurement of CA 19-9 antigen to aid in the management of pancreatic cancer patients" and "The test is useful as an aid in monitoring of disease status". These statements indicate a diagnostic purpose.
No
The device description explicitly states that the system comprises reagents, calibrators, and immunoassay analyzers (hardware), in addition to the assay itself. This indicates it is a system involving both hardware and software/reagents, not a software-only device.
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 19-9 antigen levels in human serum and plasma." This involves testing biological samples in vitro (outside the body).
- Device Description: It describes reagents, calibrators, and analyzers used to perform the test on these biological samples.
- Performance Studies: The performance studies detail analytical and clinical evaluations of the assay's performance on human samples.
- Predicate Device: It lists a predicate device which is also an IVD (a RIA assay for CA 19-9).
All these characteristics align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Access GI Monitor assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CA 19-9 antigen levels in human serum and plasma using the Access Immunoassay Systems. This device is indicated for use in the measurement of CA 19-9 antigen to aid in the management of pancreatic cancer patients. The test is useful as an aid in monitoring of disease status in those patients having confirmed pancreatic cancer whose serum CA 19-9 antigen levels exceed 10 U/mL, the cut-off value for individuals who are Lewis blood group antigen negative. Serial testing for patient CA 19-9 antigen concentrations should be used in conjunction with other clinical methods used for monitoring pancreatic cancer.
Product codes (comma separated list FDA assigned to the subject device)
NIG, JIT
Device Description
The Access GI 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 19-9 antigen in human serum and plasma.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Imprecision: Imprecision was tested for concentrations from approximately 17 to 1665 U/mL. The within run imprecision ranged from 1.7% CV to 6.4% CV. The within run imprecision ranged from 2.4% CV to 5.7% CV. Total imprecision ranged from 3.0% CV to 8.9% CV.
Analytical Sensitivity: The lowest detectable level of CA 19-9 antigen distinguishable from zero (Access GI Monitor Calibrator S0) is 0.8 U/mL.
Dilution Recovery (Linearity): Linearity studies performed by diluting 6 human Dildion Nooorory (evels with Access GI Monitor S0 Calibrator provided oon average recovery of 96%, with mean percent recoveries ranging from 93% to 100%.
Methods Comparison: A comparison of CA 19-9 antigen values from 405 samples, ranging from 0.0 to 236.0 U/mL, run with both the Access GI Monitor assay and the Fujirebio Diagnostics CA 19-9 RIA assay demonstrated acceptable agreement with the following statistical data: y = 0.9569x + 2.5726, r = 0.9007.
Sample Type Comparison: A comparison of 80 matched serum and lithium heparin plasma samples, ranging from 0.0 to 1650.9 U/mL, using the Access nopani placema campa the following statistical data using Deming calculations: v = 0.9842x - 0.5002, r = 0.9995.
Analytical Specificity: There was no significant interference from therapeutic drugs or similar compounds in the Access GI Monitor assay. In addition, there was no significant interference from potential sample contaminants (bilirubin, hemoglobin, triglycerides, human serum albumin, and rheumatoid factor).
Stability: GI Monitor reagents are stable for 56 days after opening and calibrators are stable for 90 days after opening. The calibration curve is stable for 56 days.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The 95th percentile (35 U/mL CA 19-9) for the apparently healthy subject population was out as the upper reference limit (URL) for the Access GI Monitor assay.
Relative sensitivity: 96.6%
Relative specificity: 96.0%
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.
Fujirebio Diagnostics CA 19-9 RIA
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
Image /page/0/Picture/1 description: The image shows the logo for Beckman Coulter. The logo consists of a black circle with two white curved lines inside, resembling a stylized eye or a wave. To the right of the circle, the words "BECKMAN" are 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.
The assigned 510(k) number is: Ko3303 8
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: December 8, 2003
Device Names
| Proprietary Name: | GI Monitor and GI Monitor Calibrators on the
Access® Immunoassay Systems |
|----------------------|-----------------------------------------------------------------------------------------------------|
| Common Name: | Immunological test for 116NS19-9 Antibody Defined
Antigen (CA19-9) |
| Classification Name: | System, Test, Carbohydrate Antigen (CA 19-9), for
Monitoring and Management of Pancreatic Cancer |
Predicate Device
Fujirebio Diagnostics CA 19-9 RIA Fujirebio Diagnostics, Inc. 201 Great Valley Parkway Malvern, PA 19355
510(k) Number:
Device Description
The Access GI 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 19-9 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 circular graphic on the left and the company name on the right. The graphic is a black circle with a white, stylized design inside. The text "BECKMAN" is stacked on top of "COULTER" in a bold, sans-serif font.
Intended Use
The Access GI Monitor assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CA 19-9 antigen levels in inimonodouly Tor the qualisian the Access Immunoassay Systems. This device is indicated for use in the measurement of CA 19-9 antigen to aid in the management of pancreatic cancer patients. The test is useful as an aid in monitoring of disease status in those patients having confirmed pancreatic cancer whose serum CA 19-9 antigen levels exceed 10 U/mL, the cut-off value for individuals who are Lewis blood group antigen negative. Serial testing for patient CA 19-9 antigen concentrations should be used in conjunction with other clinical methods used for monitoring pancreatic cancer.
| Attribute | Fujirebio Diagnostics
CA 19-9 RIA | Access GI Monitor |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | For the measurement of
CA 19-9 antigen in human
serum and plasma | For the measurement of
CA 19-9 antigen in human
serum and plasma |
| Assay
Principles | Utilizes the binding of CA 19-9
to a specific monoclonal
antibody in a manual, two-site
"sandwich" radioimmunoassay;
Utilizes $^{125}I$ conjugated to
monoclonal antibody | Utilizes the binding of CA 19-9
to a specific monoclonal
antibody in an automated, two-
site "sandwich"
enzymeimmunoassay;
Utilizes alkaline phosphatase
enzyme conjugated to
monoclonal antibody |
| Solid
Support | Polystyrene beads | Paramagnetic particles |
| Detection
System | Utilizes $^{125}I$ conjugated to
monoclonal antibody;
Measures bound radioactivity
with a gamma counter | Utilizes dioxetane-based
chemiluminescent substrate;
Measures light production from
a chemiluminescent reaction |
| Calibrators | Liquid calibrators prepared
from defibrinated normal
human plasma with CA 19-9
antigen at specified levels | Liquid calibrators prepared
from buffered bovine serum
albumin matrix with CA 19-9
antigen at specified levels |
Comparison of Technological Characteristics
2
Image /page/2/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 a white design inside, resembling two curved shapes intertwined. The text "BECKMAN COULTER" is written in a bold, sans-serif font, with "BECKMAN" stacked above "COULTER".
Summary of Analytical Studies
Imprecision: Imprecision was tested for concentrations from approximately 17 to 1665 U/mL. The within run imprecision ranged from 1.7% CV to 6.4% CV. 1000 Chile. The willim ranged from 2.4% CV to 5.7% CV. Total imprecision ranged from 3.0% CV to 8.9% CV.
Analytical Sensitivity: The lowest detectable level of CA 19-9 antigen distinguishable from zero (Access GI Monitor Calibrator S0) is 0.8 U/mL.
Dilution Recovery (Linearity): Linearity studies performed by diluting 6 human Dildion Nooorory (evels with Access GI Monitor S0 Calibrator provided oon average recovery of 96%, with mean percent recoveries ranging from 93% to 100%.
Methods Comparison: A comparison of CA 19-9 antigen values from 405 samples, ranging from 0.0 to 236.0 U/mL, run with both the Access GI Monitor assay and the Fujirebio Diagnostics CA 19-9 RIA assay demonstrated acceptable agreement with the following statistical data: y = 0.9569x + 2.5726, r = 0.9007.
Sample Type Comparison: A comparison of 80 matched serum and lithium heparin plasma samples, ranging from 0.0 to 1650.9 U/mL, using the Access nopani placema campa the following statistical data using Deming calculations: v = 0.9842x - 0.5002, r = 0.9995.
Analytical Specificity: There was no significant interference from therapeutic drugs or similar compounds in the Access GI Monitor assay. In addition, there was no significant interference from potential sample contaminants (bilirubin, hemoglobin, triglycerides, human serum albumin, and rheumatoid factor).
GI Monitor reagents are stable for 56 days after opening and Stability: calibrators are stable for 90 days after opening. The calibration curve is stable for 56 days.
3
Image /page/3/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a stylized circular graphic on the left, resembling a stylized eye or a swirling pattern. To the right of the graphic, the words "BECKMAN" are stacked on top of the word "COULTER" in a bold, sans-serif font. The overall design is simple and modern, with a focus on the company name and a distinctive visual element.
Summary of Clinical Studies
The 95th percentile (35 U/mL CA 19-9) for the apparently healthy subject The 90 - percentile (00 - onliner reference limit (URL) for the Access GI Monitor population was out as the apper es Gl Monitor values for apparently healthy assay. The diothbations with various non-malignant and malignant conditions are consistent with results provided in the predicate device labeling.
Results from subjects who were diagnosed with pancreatic cancer and who were monitored over the course of disease demonstrate that CA 19-9 concentrations monitored with the Access GI Monitor assay paralleled results obtained with the predicate device.
Based on the pancreatic cancer monitoring subjects, the relative sensitivity and Belou on the partificity, based on the respective URLs for the Access GI Monitor relative opodifishy, budget the predicate device (URL = 37 U/mL), were 96.6% assuy (ONE - 80 Child) aThe % agreement between the two assays was 95.1%.
Conclusion
GI Monitor and GI Monitor Calibrators on the Access Immunoassay Systems is Of Monitor and Of Ment to Fujirebio Diagnostics CA 19-9 RIA for the measurement of CA 19-9 antigen in human serum and plasma.
4
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
DEC 2 9 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Brent Taber Senior Regulatory Specialist Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318-1084
K033038 Re:
Trade/Device Name: GI Monitor and GI 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: NIG; JIT Dated: December 8, 2003 Received: December 9, 2003
Dear Mr. Taber:
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 vour 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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
5
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 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 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 (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Putman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
510(k) Number (if known):
GI Monitor and GI Monitor Calibrators on the Device Name: Access Immunoassay Systems
Indications For Use:
The Access G1 Monitor assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CA 19-9 antigen levels in human serum and plasma using the Access Immunoassay Systems. This device is indicated for use in the measurement of CA 19-9 antigen to aid in the management of pancreatic cancer patients. The test is useful as an aid in monitoring of disease status in those patients having confirmed pancreatic cancer whose serum CA 19-9 antigen levels exceed 10 U/mL. the cut-off value for individuals who are Lewis blood group antigen negative. Serial testing for patient CA 19-9 antigen concentrations should be used in conjunction with other clinical methods used for monitoring pancreatic cancer.
(PLEASE DO NOT WRITE BELOW THIS LINE--CONTINUE ON ANOTHER PAGE IF NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation (ODE)
Maria M Chan
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety Over-The Counter Use__________________________________________________________________________________________________________________________________________________________
Prescription Use_ ✔ (Per 21 CFR 801.109)
510(k)_Ko33038
(Optional Format 1-2-96) Page 32