ACTIVE PSA ELISA (DSL-10-9700)

K973243 · Diagnostic Systems Laboratories, Inc. · LTJ · Aug 3, 1998 · Immunology

Device Facts

• Record ID: K973243
• Device Name: ACTIVE PSA ELISA (DSL-10-9700)
• Applicant: Diagnostic Systems Laboratories, Inc.
• Product Code: LTJ · Immunology
• Decision Date: Aug 3, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.6010
• Device Class: Class 2

Intended Use

The DSL-9700 Active™ PSA Enzyme-Linked Immunosorbent Assay (ELISA) Kit provides materials for the quantitative measurement of Total PSA in human serum to aid in the management (monitoring the reoccurrence of prostate cancer) of prostate cancer patients. This assay is intended for in vitro diagnostic use.

Device Story

The DSL 10-9700 PSA ELISA kit is an in vitro diagnostic assay for the quantitative measurement of Total PSA in human serum. The device utilizes a non-competitive 'sandwich' ELISA format. Input consists of human serum samples; analyte is captured between an antibody immobilized on microtiter plate wells and a second antibody conjugated to horseradish peroxidase. Following decanting and washing steps to remove unbound materials, the plate is analyzed via spectrophotometer. The resulting absorbance is directly proportional to the PSA concentration in the sample. The assay is performed in a clinical laboratory setting by trained personnel. Results are used by clinicians to monitor for the recurrence of prostate cancer in patients, aiding in clinical management decisions.

Clinical Evidence

Clinical performance was evaluated by comparing the DSL 10-9700 PSA ELISA kit against the DPC IMMULITE PSA assay using 193 human serum samples. The study demonstrated a correlation coefficient of r = 0.96 and a linear regression equation of Y = 1.11[DPC IMMULITE] + 0.77.

Technological Characteristics

Non-competitive sandwich ELISA format; utilizes microtiter plates with immobilized antibodies and horseradish peroxidase-conjugated detection antibodies. Quantitative measurement via spectrophotometric absorbance analysis.

Indications for Use

Indicated for the quantitative measurement of Total PSA in human serum to aid in the management and monitoring of prostate cancer recurrence in 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

• DPC IMMULITE PSA assay

Submission Summary (Full Text)

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K97324

Diagnostic Systems Laboratories, Inc. 445 Medical Center Boulevard Webster Texas 77598-4217 USA Tel [phone] Fax [phone]

> Customer Assistance Center Tel [phone] Fax [phone] Email [e-mail]

## SUMMARY OF SAFETY AND EFFECTIVENESS

DSL 10-9700 PSA ELISA Kit Name of Device: Classification Name: Enzyme-linked Immunosorbent Assay for PSA Analyte Code and Name: Prostate Specific Antigen Regulatory Class: 11

- Submitter: John Class Diagnostic Systems Laboratories, Inc. 445 Medical Center Boulevard Webster, Texas 77598 Phone: [phone]
July 28, 1998 Date:

The DSL 10-9700 PSA ELISA kit was developed for the quantitative measurement of Total PSA in human serum. The ELISA format is a non-competitive assay in which the analyte to be measured is "sandwiched" between two antibodies. The first antibody is immobilized to the microtiter plate wells, the other antibody is coniugated the the enzyme horseradish peroxidase for detection. The analyte present is bound by both the antibodies to form a "sandwich" complex. Unbound materials are removed by decanting and washing the microtiter plate. The resultant is analyzed in a spectrophotometer for absorbance. The amount of bound PSA is directly proportional to the concentration of the PSA present in the sample.

The DSL PSA ELISA assay is intended for the quantitative determination of Total PSA in human serum to aid in the management (monitoring the reoccurrence of prostate cancer) of prostate cancer patients.

The DSL 10-9700 PSA ELISA is substantially equivalent to the DPC IMMULITE PSA assay.

To demonstrate substantial equivalence between the two assays, human serum samples (n = 193) were collected and assayed using both methods. Samples were chosen based on expected PSA levels so that samples with low, intermediate and high levels would be evaluated. Linear regression analysis of the results obtained for the comparison gave the equation Y = 1.11[DPC IMMULITE] + 0.77 with a correlation coefficient of (r) = 0.96.

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

3 1998 AUG

Mr. John Class Diagnostic Systems Laboratories, Inc. 445 Medical Center Boulevard Webster, Texas 77598

K973243/S2 Re : Active™ PSA ELISA (DSL-10-9700) Trade Name: Regulatory Class: II Product Code: LTJ Dated: June 9, 1998 Received: June 9, 1998

Dear Mr. Class:

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 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). 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 reqistration, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, 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 regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. 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 regulations.

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## Page 2

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 [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). Other 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 [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Toutman

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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FDA/CDRH/ODE/DMG

## 29 Jul 93 0 0

510(k) Number (if known): K973243

Device Name: Active™ PSA ELISA

Indications For Use:

The DSL-9700 Active™ PSA Enzyme-Linked Immunosorbent Assay (ELISA) Kit provides materials for the quantitative measurement of Total PSA in human serum to aid in the management (monitoring the reoccurrence of prostate cancer) of prostate cancer patients. This assay is intended for in vitro diagnostic use.

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

Concurrence of CDRH, Office of Device Evaluation (QDE)

Peter E. Maison

(Division Sign-Off)

(División Sign-Olm)
Division of Clinical Laboratory Devices k973243
510(k) Number

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OR

Over-The-Counter Use