ACCESS OV MONITOR IMMUNOENZYMETRIC ASSAY

K023597 · Beckman Coulter, Inc. · LTK · Dec 11, 2002 · Immunology

Device Facts

• Record ID: K023597
• Device Name: ACCESS OV MONITOR IMMUNOENZYMETRIC ASSAY
• Applicant: Beckman Coulter, Inc.
• Product Code: LTK · Immunology
• Decision Date: Dec 11, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.6010
• Device Class: Class 2

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.

Device Story

Access OV Monitor is a paramagnetic particle, chemiluminescent immunoassay for quantitative CA 125 antigen measurement in human serum and plasma. Used on Access Immunoassay Systems in clinical laboratory settings by trained personnel. Device processes patient samples to determine antigen concentration; results provided to clinicians for serial monitoring of ovarian cancer patients. Output aids in disease management by tracking antigen levels over time. Benefits include standardized, automated monitoring of ovarian cancer progression or response to therapy.

Clinical Evidence

Bench testing included analytical sensitivity (0.5 U/mL), precision (within-run 1.3-2.4% CV; total 3.9-6.0% CV), and interference studies. Clinical correlation study compared 290 samples against Abbott Axsym CA 125 (r=0.9871). Clinical sensitivity was 84.4% (95% CI: 71.2%-92.3%) and specificity was 82.5% (95% CI: 82.5%-90.0%). Longitudinal monitoring of 20 ovarian cancer patients (stages I-IV) over 7-53 months showed results comparable to the predicate.

Technological Characteristics

Paramagnetic particle, chemiluminescent immunoassay. Designed for use on Access Immunoassay Systems. Analytical range: 0.5 U/mL to 5,000 U/mL. Quantitative measurement of CA 125 antigen.

Indications for Use

Indicated for the quantitative measurement of CA 125 antigen in human serum and plasma to aid in the management of ovarian cancer patients. Intended for serial testing in conjunction with other clinical methods for monitoring ovarian cancer.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Abbott Axsym CA 125 assay

Submission Summary (Full Text)

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DEC 1 1 2002

# 510(k) Summary K023597

### 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.

# Summary of Studies

Specificity: There was no significant interference from therapeutic drugs or similar compounds using the Access OV Monitor. The following compounds were tested: doxorubicin at 100 µg/mL, amthopterin at 500 μg/mL, carboplatin at 1000 μg/mL, cyclophosphamide at 1000 μg/mL, 5-fluorouracil at 1000 µg/mL, cisplatin at 2000 µq/mL, melphalan at 100 µg/mL, acetominopehn at 200 µg/mL, aspirin at 500 µg/mL, paclitaxel at 10 ng/mL, biotin at 50 ng/mL and vitamin D2 at 1 U/mL.

In addition, there was no significant interference (<10% change) from potential sample contaminants (total protein at 9%, bilirubin at 20 mg/dL. hemoglobin at 1000 mg/dL, and triglycerides at 1800 mg/dL).

Analytical Sensitivity: The lowest detectable level of CA 125 antigen distinguishable from zero (Access® OV Monitor Calibrator S0) is 0.2 U/mL. An analytical sensitivity of 0.5 U/mL will be claimed in the labeling. Samples can be accurately measured between the lower limit of detection and the highest calibrator value (approximately 0.5 U/mL and 5,000 U/mL).

Recovery: Linearity studies performed by diluting 6 human serum samples at various levels with Access® OV Monitor Zero Calibrator provided an average recovery of 107%, with individual recoveries ranging from 100% to 118%.

Precision: Within-run assay imprecision was tested for concentrations from approximately 24 to 2962 U/mL. The within run imprecision ranged from 1.3% CV to 2.4% CV. Between-run assay imprecision ranged from 3.3% CV to 6.0% CV. Total imprecision ranged from 3.9% CV to 6.0% CV.

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Correlation: A comparison of OV Monitor values from 290 samples, ranging from approximately 0 to 600 U/mL, run with both the Access® OV Monitor immunoassay and the Abbott Axsym CA 125 assay demonstrated an acceptable correlation coefficient of: r = 0.9871; and a bias with a slope of y = 1.197 + (-0.985) across the range of the Axsym assay (approximately 0 - 600 U/mL).

Clinical Data: The data generated demonstrates comparable clinical sensitivity and clinical specificity for the Access OV Monitor and the Abbott Axsym CA 125 assays. The clinical sensitivity and specificity were calculated at: Sensitivity = 84.4% (95% confidence interval = 71.2% -92.3%); Specificity = 82.5% (95% confidence interval = 82.5% - 90.0%).

Results from 20 female subjects who where diagnosed with ovarian cancer (stages I to IV) and who were monitored (7 months to 53 months) over the course of disease demonstrate that CA 125 concentration obtained with the Access OV Monitor assay were comparable and paralleled those results obtained with the FDA cleared predicate device.

### Conclusion

The data generated demonstrates acceptable non-clinical (laboratory) performance, and good correlation between the Access OV Monitor assay and the Abbott Axsym CA 125 assay. Clinical sensitivity and clinical specificity for the Access OV Monitor and the Abbott Axsym CA 125 assays were found to be substantially equivalent.

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# 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 eagle with three stripes forming its body and wing. The eagle faces right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

198 Gaither Road

Ms. Mara Caler Regulatory Affairs Beckman Coulter, Inc. 4300 N. Harbor Blvd Fullerton, CA 92835

Re:

k023597 Trade/Device Name: Access® OV Monitor Regulation Number: 21 CFR 866.6010 Regulation Name: Tumor-Associated Antigen Immunological Test System Regulatory Class: Class II Product Code: LTK Dated: November 25, 2002 Received: November 27, 2002

Dear Ms. Caler:

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 (OS) regulation (21 CFR Part 820).

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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 [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] 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

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510(k) Number (K023597):

Device Name: Access® OV Monitor

# 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)

S. Plewes for S. Bautista

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The Counter Use

(Optional Format 1-2-96)