ACTIVE PSA IRMA (DSL-9700)

K973244 · Diagnostic Systems Laboratories, Inc. · LTJ · Aug 3, 1998 · Immunology

Device Facts

• Record ID: K973244
• Device Name: ACTIVE PSA IRMA (DSL-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 Immunoradiometric Assay (IRMA) 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-9700 Active™ PSA IRMA is an in vitro diagnostic kit for quantitative measurement of Total PSA in human serum. It utilizes a non-competitive immunoradiometric assay (IRMA) format. PSA analyte in the sample is captured in a 'sandwich' complex between an immobilized antibody on a coated tube and a radiolabelled antibody. After decanting and washing to remove unbound materials, the tube is analyzed in a gamma counter. The resulting net counts are directly proportional to the PSA concentration. The device is used in clinical laboratory settings by trained personnel. Results assist healthcare providers in monitoring prostate cancer patients for disease recurrence.

Clinical Evidence

Clinical evaluation involved a comparative study of 286 human serum samples across low, intermediate, and high PSA levels. Results showed a correlation coefficient of r = 0.97 when compared to the DPC IMMULITE PSA assay, with a linear regression equation of Y = 1.25(DPC IMMULITE) + 0.33.

Technological Characteristics

Immunoradiometric assay (IRMA) utilizing coated tubes and radiolabelled antibodies. Quantitative measurement based on gamma counter detection of bound radiolabelled complex. In vitro diagnostic kit format.

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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K973244j

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]

AUG 3 1998

## SUMMARY OF SAFETY AND EFFECTIVENESS

DSL 9700 PSA IRMA Kit Name of Device: Classification Name: Immunoradiometric Assay for PSA Analyte Code and Name: PSA 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 9700 PSA IRMA kit was developed for the quantitative measurement of Total PSA in human serum. The IRMA 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 coated tube, the other antibody is radiolabelled 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 tube. The resultant is analyzed in a gamma counter for net counts. The amount of bound PSA is directly proportional to the concentration of the PSA present in the sample.

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

The DSL 9700 PSA IRMA is substantially equivalent to the DPC IMMULITE PSA assay.

To demonstrate substantial equivalence between the two assays, human serum samples (n = 286) 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 = 1.25(DPC IMMULITE) + 0.33 with a correlation coefficient of (r) = 0.97.

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3 1998 AUG

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

K973244/S2 Re : Active™ PSA IRMA (DSL-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 leqally 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 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 (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 A substantially equivalent determination assumes compliance to 895. 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 beqin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally 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 Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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FDATODRH/ODF ADMO

0 3 29 Jul 13

510(k) Number (if known): K973244

Device Name: Active™ PSA IRMA

Indications For Use:

The DSL-9700 Active™ PSA Immunoradiometric Assay (IRMA) 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)

(Division Sign-Off)
Division of Clinical Laboratory Devices

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

OR