IMMULITE 2000 3RD GENERATION PSA

K974842 · Diagnostic Products Corp. · LTJ · Apr 21, 1998 · Immunology

Device Facts

• Record ID: K974842
• Device Name: IMMULITE 2000 3RD GENERATION PSA
• Applicant: Diagnostic Products Corp.
• Product Code: LTJ · Immunology
• Decision Date: Apr 21, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.6010
• Device Class: Class 2

Intended Use

The DPC IMMULITE 2000 3ª Gen. PSA kit is intended for the quantitative measurement of prostate specific antigen (PSA) in human serum as an adjunctive test to aid in the management of prostate cancer in patients.

Device Story

The IMMULITE 2000 3rd Gen. PSA is an in vitro diagnostic kit for the quantitative measurement of prostate-specific antigen (PSA) in human serum. Used in clinical laboratory settings by trained personnel, the device aids in the management of prostate cancer. It functions as an immunoassay system; the specific methodology involves the measurement of PSA levels in patient serum samples. Healthcare providers use the resulting quantitative PSA values to monitor patients and inform clinical decision-making regarding prostate cancer management. The device provides objective data to assist in the ongoing assessment of disease status.

Technological Characteristics

In vitro diagnostic immunoassay kit for quantitative measurement of PSA in human serum. Operates as a laboratory-based diagnostic system.

Indications for Use

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

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo consists of a stylized image of an eagle with three heads, all facing to the right. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around it.

APR 2 1 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Robert M Di Tullio Director, Quality and Requlatory Affairs Diagnostic Products Corporation (DPC) B13-B18, 111 Canfield Avenue Randolph, New Jersey 07869

Re : K974842/S1 IMMULITE 2000® Third Generation PSA Trade Name: Regulatory Class: II Product Code: LTJ Dated: March 19, 1998 Received: March 24, 1998

Dear Mr. Tullio:

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 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 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 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.

{1}------------------------------------------------

Page 2

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

:

Sincerely yours,

Steven Putman

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

{2}------------------------------------------------

Page _________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known):

Device Name: IMMULITE 2000 3rd Gen. PSA

Indications for Use:

The DPC IMMULITE 2000 3ª Gen. PSA kit is intended for the quantitative measurement of prostate specific antigen (PSA) in human serum as an adjunctive test to aid in the management of prostate cancer in patients.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Peter E. Mackin

(Division Sign-Off) Division of Clinical Laboratory Devices

510(k) Number K974842

Prescription Use

OR

Over-The-Counter Use