PROSTATE SPECIFIC ANTIGEN METHOD

K973101 · Dade Chemistry Systems, Inc. · LTJ · Sep 18, 1997 · Immunology

Device Facts

• Record ID: K973101
• Device Name: PROSTATE SPECIFIC ANTIGEN METHOD
• Applicant: Dade Chemistry Systems, Inc.
• Product Code: LTJ · Immunology
• Decision Date: Sep 18, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.6010
• Device Class: Class 2

Intended Use

The PSA method is used on the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module to quantitatively measure PSA in human serum and plasma. Measurements of PSA aid in the management of prostate cancer patients.

Device Story

The PSA method is a one-step enzyme immunoassay performed on the Dimension® RxL clinical chemistry system. It utilizes chromium dioxide particles coated with monoclonal antibodies and β-galactosidase-labeled monoclonal antibodies to form a particle/PSA/conjugate sandwich. Following magnetic separation and washing, the bound β-gal catalyzes the hydrolysis of chlorophenol red-β-d galactopyranoside (CPRG) to chlorophenol red (CPR). The resulting color change, measured at 577nm, is directly proportional to the PSA concentration in the patient sample. The device is used in clinical laboratory settings to assist healthcare providers in managing prostate cancer patients by providing quantitative PSA levels.

Clinical Evidence

Split-sample comparison of 596 clinical patient samples (range 0.00 to 99.9 ng/mL) between the Dimension® RxL PSA method and the aca® plus PSA Test Kit. Results showed a correlation coefficient of 0.994, a slope of 1.06 ± 0.01, and an intercept of -0.07 ± 0.14 ng/mL. The assay performance was consistent with the clinical status of patients across all healthy and disease state categories.

Technological Characteristics

One-step enzyme immunoassay; sandwich format using monoclonal antibodies; chromium dioxide (CrO2) particles; β-galactosidase label; colorimetric detection at 577nm; heterogeneous immunoassay module; automated clinical chemistry system.

Indications for Use

Indicated for the quantitative measurement of PSA in human serum and plasma to aid in the management of prostate cancer patients.

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

• aca® plus PSA Test Kit (K973101)

Submission Summary (Full Text)

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K973101

## DADE INTERNATIONAL

Image /page/0/Picture/2 description: The image shows the word "DADE" in bold, black, sans-serif font. The letters are large and take up most of the frame. The background is white, providing a strong contrast with the black letters. The text appears to be a title or heading due to its prominent size and weight.

.

SEP 1 8 1997

Chemistry Systems P.O. Box 6101 Newark, DE 19714

## Summary of Safety and Effectiveness Information

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.

| Submitter's Name: | Rebecca S. Ayash<br>Dade International Inc.<br>Building 500, Mailbox 514<br>P.O. Box 6101<br>Newark, DE 19714-6101<br>Phone: [phone]<br>FAX: [phone] |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Preparation: | 8/15/97 |
| Device Name: | Prostate Specific Antigen (PSA) Method |
| Classification Name: | Prostate Specific Antigen for Management of<br>Prostate Cancer |
| Predicate Device: | aca® plus PSA Test Kit |

Device Description: The PSA method is a one-step enzyme immunoassay. Sample is incubated with chromium dioxide particles (CrO2) coated with monoclonal antibodies specific for a binding site on the PSA molecule and conjugate reagent [β-galactosidase (β-gal) labeled monoclonal antibodies specific for a second binding site on the PSA molecule] to form a particle/PSA/conjugate sandwich. Unbound conjugate and analyte are removed by magnetic separation and washing. The sandwich bound ß-gal catalyzes the hydrolysis of chlorophenol red-β-d galactopyranoside (CPRG) to chlorophenol red (CPR). The color change measured at 577nm due to the formation of CPR is directly proportional to the concentration of PSA present in the patient sample.

Intended Use: The PSA method is used on the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module to quantitatively measure PSA in human serum and plasma. Measurements of PSA aid in the management of prostate cancer patients.

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## Comparison to Predicate Device:

| Item | Dimension® RxL PSA | aca® plus PSA |
|---------------|--------------------------------------------------------|------------------------------------------------------------|
| Technology | Sandwich format<br>monoclonal antibody<br>immunoassay | Sandwich format<br>monoclonal antibody<br>immunoassay |
| Detection | Colorimetric rate<br>measurement at 577nm<br>and 700nm | Colorimetric endpoint<br>measurement at 577nm<br>and 600nm |
| Specimen type | serum | serum |
| Sample Size | 40μL | 100μL |

Comments on Substantial Equivalence: Split sample comparison between the PSA method on the Dimension® RxL clinical chemistry system and the aca® plus PSA Test Kit gave a correlation coefficient of 0.994, slope of 1.06 ± 0.01 and an intercept of -0.07 ± 0.14 ng/mL when tested with 596 clinical patient samples ranging from 0,00 to 99.9 ng/mL. The Dimension® RxL assay compared well with the aca® plus assay in all healthy and disease state categories. Data obtained were consistent with the clinical status of the patient.

Conclusion: The PSA method for the Dimension® RxL system with the heterogeneous immunoassay module is substantially equivalent in principle and performance to the aca® plus PSA Test Kit based on the split sample comparison summarized above.

Rebecca S. Cyphers

Rebecca S. Avash Regulatory Affairs and Compliance Manager Date: 8/15/97

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Rebecca S. Ayash Requlatory Affairs and Compliance Manager Dade International SEP 1 8 1997 Building 500, Mailbox 514 P.Ó. Box 6101 Newark, Delaware 19714-6101 K973101 Re : Trade Name: Prostate Specific Antigen (PSA) Method Requlatory Class: II Product Code: LTJ Dated: August 15, 1997 Received: August 19, 1997

Dear Ms. Ayash:

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, Drug, and Cosmetic Act (Act). 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 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 regulations 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 requirement, 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 Failure to comply with the GMP requlation may result in assumptions. requlatory 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 [phone].

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Qther general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number [phone] or at [phone] 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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## Indications Statement

Device Name: Prostate Specific Antigen (PSA) Method

Indications for Use: The PSA method for the Dimension® RxL with the heterogeneous immunoassay module is a device used to measure PSA in serum as an aid in the management of prostate cancer patients.

Rebecca S. Ayers

Rebecca S. Ayas Regulatory Affairs and Compliance Manager Date: 8/15/97

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Peter E. Macken

K973101
510(k) Number

Division Sign-Off Office of Device Evaluation

Prescription Use ✓