THIRD GENERATION PSA CONTROL MODULE

K981455 · Diagnostic Products Corp. · JJY · May 13, 1998 · Clinical Chemistry

Device Facts

• Record ID: K981455
• Device Name: THIRD GENERATION PSA CONTROL MODULE
• Applicant: Diagnostic Products Corp.
• Product Code: JJY · Clinical Chemistry
• Decision Date: May 13, 1998
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

DPC's IMMULITE® Third Generation PSA Control Module is an assayed, tri-level PSA control intended for use with the IMMULITE and IMMULITE 2000 Third Generation PSA assays. It is intended as an aid in monitoring day-to-day performance.

Device Story

The IMMULITE® Third Generation PSA Control Module is an assayed, tri-level control product used in clinical laboratories to monitor the performance of IMMULITE and IMMULITE 2000 Third Generation PSA assays. It serves as a quality control tool to ensure the accuracy and reliability of daily assay results. Laboratory personnel use the control to verify that the assay system is functioning within established parameters. By monitoring day-to-day performance, the device helps clinicians maintain confidence in the PSA test results used for patient monitoring.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Assayed, tri-level control material. Designed for use with IMMULITE and IMMULITE 2000 Third Generation PSA assay systems. Class I device (21 CFR 862.1660).

Indications for Use

Indicated for use as an assayed, tri-level quality control material to monitor the day-to-day performance of IMMULITE and IMMULITE 2000 Third Generation PSA assays in a clinical laboratory setting.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Predicate Devices

• K972021

Submission Summary (Full Text)

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## MAY | 3 1998

## 510(k) Summary Safety and Effectiveness

This summary of safety and effectiveness information has been prepared in accordance with the requirements of SMDA 1990 and 21 CFR Part 807.92

| Name:<br>Address: | Diagnostic Products Corporation<br>5700 West 96th Street<br>Los Angeles, CA 90045-5597<br>ri |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone Number:<br>Facsimile Number: | [phone]<br>[phone] |
| Contact Person: | Edward M. Levine, Ph.D.<br>Director of Clinical Affairs |
| Date of Preparation: | April 21, 1998 |
| Device Name:<br>Trade: | IMMULITE® Third Generation PSA Control Module<br>Device intended as an aid in monitoring the performance of DPC's<br>Third Generation PSA assays |
| Catalog Number: | LUPCM |
| Classification: | Class I device, 75-JJY (21 CFR 862.1660) |
| Manufacturer: | Diagnostic Products Corporation<br>5700 West 96th Street<br>Los Angeles, CA 90045-5597 |
| Establishment<br>Registration #: | DPC's Establishment Registration No. is 2017183 |
| Description of Device: | DPC's IMMULITE® Third Generation PSA Control Module is an<br>assayed, tri-level PSA control intended for use with both the<br>IMMULITE® and IMMULITE 2000® Third Generation PSA<br>assays. |
| Intended Use of the<br>Device: | DPC's IMMULITE® Third Generation PSA Control Module is an<br>assayed, tri-level PSA control intended for use with the<br>IMMULITE and IMMULITE 2000 Third Generation PSA assays.<br>It is intended as an aid in monitoring day-to-day performance. |
| Clinical Studies: | Not applicable |

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## Conclusion:

The data presented in this summary of safety and effectiveness is the data that the Food and Drug
Administration used in againting DPC substantial equivalence for IMMULITE® T Generation PSA Control Module.

Edwin h. Land

Edward M. Levine, Ph.D. Director of Clinical Affairs

Hril/18

Date

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a representation of human figures.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 1 3 1998

Edward M. Levine, Ph.D. Director of Clinical Affairs Diagnostic Products Corporation 5700 West 96th Street Los Angeles, California 90045

Re: K981455 Trade Name: IMMULITE® Third Generation PSA Control Module Regulatory Class: I Product Code: JJY Dated: April 21, 1998 Received: April 23, 1998

Dear Dr. Levine:

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.

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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 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 Butman

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): K972021

Device Name: IMMULITE® Third Generation PSA Control Module

Indications For Use:

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IMMULITE Third Generation PSA Control Module is an assayed, tri-level PSA control intended for use with IMMULITE and IMMULITE 2000 Third Generation PSA assays. It is intended as an aid in monitoring day-to-day assay performance.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Peter E. Malm

Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number

Prescription Use _ (Per 21 CFR 801:109) -- ------------------------------------------------------------------------------------------------------------------------------------------------------

Over-The-Counter Use_

(Optional Format 1-2-96)