(8 days)
No
The summary describes a standard immunoassay for measuring CA 125 levels and does not mention any AI or ML components.
No.
The device is an in vitro diagnostic assay used for quantitative determination of CA 125 antigen levels to aid in the management of ovarian cancer patients, not for treatment.
Yes
The device is described as an "immunoassay for the quantitative determination of CA 125 antigen levels in human serum and plasma" and is "indicated for use in the measurement of CA 125 antigen to aid in the management of ovarian cancer patients." This indicates its use in providing information to help with diagnosis or monitoring of a disease.
No
The device description explicitly states that the system comprises "reagents, calibrators and the Access Immunoassay Systems family," indicating the presence of hardware components (the immunoassay systems) and consumables (reagents and calibrators) in addition to any potential 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 125 antigen levels in human serum and plasma". This involves testing biological samples in vitro (outside the body).
- Device Description: The description mentions "reagents, calibrators and the Access Immunoassay Systems family", which are components used for laboratory testing of biological samples.
- Predicate Device: The predicate device is also an "Access OV Monitor Assay", indicating a history of this type of device being used for in vitro testing.
The core function of the device is to analyze a biological sample (serum or plasma) to measure a specific substance (CA 125 antigen) to aid in the management of a disease (ovarian cancer). This is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Access OV Monitor assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CA 125 antigen levels in human serum and plasma, using the Access Immunoassay Systems. This device is indicated for use in the measurement of CA 125 antigen to aid in the management of ovarian cancer patients. Serial testing for patient CA 125 antigen concentrations should be used in conjunction with other clinical methods used for monitoring ovarian cancer.
Product codes (comma separated list FDA assigned to the subject device)
LTK
Device Description
The Access® OV Monitor reagents, calibrators and the Access Immunoassay Systems family comprise the Access Immunoassay System for the quantitative determination of CA 125 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
In order to demonstrate that the Access OV Monitor assay on the Dxl system is substantially equivalent to the Access OV Monitor assay on the Access 2 system. method comparison, precision and analytical sensitivity studies were conducted. The Access OV Monitor assay met the established acceptance criteria for method comparison, precision and analytical sensitivity.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
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MAY - 2 2003
510(K) Summary 1.4
(Page 1 of 2)
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.
510(k) Number K031297
Date Prepared: April 22,2003
| Submitter | Contact Person |
|---|---|
| Beckman Coulter, Inc | Lynn Weist |
| 1000 Lake Hazeltine Drive | Staff Regulatory Affairs Specialist |
| Chaska, MN 55318 | Phone: 952-368-1271 |
| Fax: 952-368-7710 |
General Information
| Proprietary Name | Access® OV Monitor Assay |
|---|---|
| Classification Name | Tumor Associated Antigen Immunological Test System |
| Device Class | Class II |
| Legally Marketed | |
| (Unmodified) Device | Access OV Monitor Assay (K023597, cleared 12/11/02) |
Device Description
The Access® OV Monitor reagents, calibrators and the Access Immunoassay Systems family comprise the Access Immunoassay System for the quantitative determination of CA 125 antigen in human serum and plasma.
Intended Use
The Access OV Monitor assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CA 125 antigen levels in human serum and plasma, using the Access Immunoassay Systems. This device is indicated for use in the measurement of CA 125 antigen to aid in the management of ovarian cancer patients. Serial testing for patient CA 125 antigen concentrations should be used in conjunction with other clinical methods used for monitoring ovarian cancer.
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510(k) Summary
(Page 2 of 2)
Description of the Modification to the Legally Marketed Device
The modification to the Access OV Monitor assay is to add a new instrument platform, the Beckman Coulter UniCel™ Dxl 800 Access® Immunoassay System, to the family of Access Immunoassay Systems. The Dxl System is a new model within the same model series of Access Immunoassay Systems manufactured and distributed by Beckman Coulter, Inc. The DxI System was cleared for marketing by FDA on January 28, 2003, (K023764).
The DxI uses the same Access OV Monitor reagents and calibrators, packaged the same as for the Access 2 System. The formulations of the substrate and wash buffer used with the Access OV Monitor assay are unchanged. There are no changes to the intended uses, technical specifications or final performance specifications and claims for the assay.
Supporting Data
In order to demonstrate that the Access OV Monitor assay on the Dxl system is substantially equivalent to the Access OV Monitor assay on the Access 2 system. method comparison, precision and analytical sensitivity studies were conducted. The Access OV Monitor assay met the established acceptance criteria for method comparison, precision and analytical sensitivity.
Conclusion
The information provided in this submission supports a substantial equivalence determination, and therefore, 510(k) premarket notification clearance of the Access OV Monitor assay on the UniCel Dxl 800 Access Immunoassay System.
Section of the consisted
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 features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The image is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in black, uppercase letters.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Lynn Weist Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, Minnesota 55318-1084
MAY - 2 2003
Re: K031297 Trade/Device Name: Access® OV Monitor Assay Regulation Number: 21 CFR § 866.6010 Regulation Name: Tumor associated antigen immunological test system Regulatory Class: II Product Code: LTK Dated: April 23, 2003 Received: April 24, 2003
Dear Ms. Weist:
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 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). 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.
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Page 2 -
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 Butman
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
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510(k) Number (if known): K031297
PAGE 1 OF 1
Device Name: Access® OV Monitor Assay
Indications for Use:
The Access OV Monitor assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CA 125 antigen levels in human serum and plasma, using the Access Immunoassay Systems. This device is indicated for use in the measurement of CA 125 antigen to aid in the management of ovarian cancer patients. Serial testing for patient CA 125 antigen concentrations should be used in conjunction with other clinical methods used for monitoring ovarian cancer.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-the-Counter Use (per 21 CFR 801.109) (Optional Format 1-2-96) al Laboratory Devices 12031297 510(k) Number.