IMMULITE 2000 PSA

K972095 · Diagnostic Products Corp. · LTJ · Aug 22, 1997 · Immunology

Device Facts

• Record ID: K972095
• Device Name: IMMULITE 2000 PSA
• Applicant: Diagnostic Products Corp.
• Product Code: LTJ · Immunology
• Decision Date: Aug 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.6010
• Device Class: Class 2

Intended Use

The DPC IMMULITE 2000 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 PSA kit is an in vitro diagnostic assay for the quantitative measurement of prostate specific antigen (PSA) in human serum. It is designed for use in clinical laboratory settings by trained laboratory personnel. The device utilizes an immunoassay principle to detect PSA levels, which serves as an adjunctive tool for healthcare providers in the clinical management of prostate cancer. The output is a quantitative concentration value of PSA, which clinicians use alongside other clinical information to monitor disease status or treatment response. The device is intended for prescription use only.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

In vitro diagnostic immunoassay kit for quantitative measurement of PSA in human serum. Product code: LTJ. Regulatory class: II.

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)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three wavy lines representing the feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

## Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Robert M. Di Tullio Director, Quality and Requlatory Affairs Diaqnostic Products Corporation 5700 West 96th Street · Los Angeles, California 90045

AUG 222 1997

Re: K972095 Trade Name: Immulite 2000 PSA Kit Requlatory Class: II Product Code: LTJ Dated: May 30, 1997 Received: June 4, 1997

Dear Mr. Di 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, Druq, 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 requlation (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 miqht 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 your 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 (301) Additionally, for questions on the promotion and 594-4588. 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 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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510(k) Number (if known):

Device Name: IMMULITE 2000 PSA

Indications for Use:

The DPC IMMULITE 2000 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. Maxim

(Division Sign-Off) Division of Clinical Laboratory Devices

510(k) Number

Prescription Use

OR

Over-The-Counter Use