PSA CONTROLS

K960154 · Diagnostic Products Corp. · JJX · Mar 13, 1996 · Clinical Chemistry

Device Facts

• Record ID: K960154
• Device Name: PSA CONTROLS
• Applicant: Diagnostic Products Corp.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Mar 13, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

DPC's PSA Controls are designed for use as an assayed quality control serum in the clinical chemistry laboratory to monitor the accuracy and precision of the Coat-A-Count PSA IRMA procedure. They are intended strictly for in vitro diagnostic use.

Device Story

Assayed tri-level control serum; used in clinical chemistry laboratories; monitors accuracy and precision of DPC Coat-A-Count PSA IRMA procedure; provides quality control verification for in vitro diagnostic testing.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Assayed tri-level control serum; in vitro diagnostic use; liquid/serum-based matrix.

Indications for Use

Indicated for use as an assayed quality control serum in clinical chemistry laboratories to monitor the accuracy and precision of the Coat-A-Count PSA IRMA procedure.

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.

Reference Devices

• Coat-A-Count PSA IRMA

Submission Summary (Full Text)

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Diagnostic Products Corporation
5700 West 96th Street
Los Angeles, CA 90045
Tel: [phone]
Fax: [phone]
MAR 13 1996
K. 96C154

# DPC

## 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:** | Diagnostic Products Corporation |
| --- | --- |
| **Address:** | 5700 West 96th Street
Los Angeles, California 90045-5597 |
| **Telephone Number:** | [phone] |
| **Facsimile Number:** | [phone] |
| **Contact Person:** | Edward M. Levine, Ph.D.
Manager of Clinical Affairs |
| **Date of Preparation:** | January 12, 1996 |
| **Device Name:** | PSA Controls |
| **Trade:** | Device intended as an aid in monitoring the performance of DPC's Coat-A-Count® PSA IRMA. |
| **Catalog Number:** | PSAC1, PSAC2, PSAC3 |
| **Classification:** | Class I device, 82-JJX (21 CFR 862.1660) |
| **Manufacturer:** | Diagnostic Products Corporation
5700 West 96th Street
Los Angeles, California 90045-5597 |
| **Establishment Registration Number:** | DPC's Registration Number is 2017183 |
| **Description of Device:** | DPC's PSA Controls are assayed tri-level controls intended for use in the quality control of DPC's Coat-A-Count PSA IRMA. |
| **Intended Use of the Device:** | DPC's PSA Controls are designed for use as an assayed quality control serum in the clinical chemistry laboratory to monitor the accuracy and precision of the Coat-A-Count PSA IRMA procedure. They are intended strictly for in vitro diagnostic use. |
| **Clinical Studies:** | Not applicable |
| **Conclusion:** | The conclusions drawn from the nonclinical tests demonstrate that the device is safe and effective. |

Edward M. Levine, Ph.D.<br/>
Manager of Clinical Affairs

Date: 12/16