PROSTATE SPECIFIC ANTIGEN (RSA) CONTROL MODDULE (PSACM)

K962975 · Diagnostic Products Corp. · JJX · Aug 29, 1996 · Clinical Chemistry

Device Facts

• Record ID: K962975
• Device Name: PROSTATE SPECIFIC ANTIGEN (RSA) CONTROL MODDULE (PSACM)
• Applicant: Diagnostic Products Corp.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Aug 29, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

DPC's PSA Control Module is designed for use as an assayed quality control serum in the clinical chemistry laboratory to monitor the accuracy and precision of both the Coat-A-Count PSA IRMA and IMMULITE PSA procedures. 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 and IMMULITE PSA assays; provides quality control verification for in vitro diagnostic procedures.

Clinical Evidence

No clinical data; nonclinical tests demonstrate safety and effectiveness.

Technological Characteristics

Assayed tri-level control serum; in vitro diagnostic quality control material.

Indications for Use

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

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 assay
• IMMULITE PSA assay

Submission Summary (Full Text)

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Diagnostic Products Corporation
5700 West 96th Street
Los Angeles, CA 90045
Tel: [phone]
Fax: [phone]
K 96 2975
AUG 29 1996

# 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:
**Address:** | Diagnostic Products Corporation
5700 West 96th Street
Los Angeles, California 90045-5597 |
| --- | --- |
| Telephone Number:
**Facsimile Number:** | [phone]
[phone] |
| Contact Person: | Edward M. Levine, Ph.D.
Director of Clinical Affairs |
| Date of Preparation:
**Device Name:**
**Trade:** | July 26, 1996
PSA Control Module
Device intended as an aid in monitoring the performance of DPC's Coat-A-Count® PSA IRMA assay and the IMMULITE PSA assay. |
| Catalog Number:
**Classification:**
**Manufacturer:** | PSACM
Class I device, 82-JJX (21 CFR 862.1660)
Diagnostic Products Corporation
5700 West 96th Street
Los Angeles, California 90045-5597 |
| Establishment Registration Number:
**Description of Device:** | DPC's Registration Number is 2017183
DPC's PSA Control Module is an assayed tri-level control intended for use in the quality control of DPC's Coat-A-Count PSA IRMA assay and DPC's IMMULITE PSA assay. |
| Intended Use of the Device: | DPC's PSA Control Module is designed for use as an assayed quality control serum in the clinical chemistry laboratory to monitor the accuracy and precision of both the Coat-A-Count PSA IRMA and IMMULITE PSA procedures. They are intended strictly for in vitro diagnostic use. |
| Clinical Studies:
**Conclusion:** | Not applicable |

The conclusions drawn from the nonclinical tests demonstrate that the device is safe and effective.

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

7/26/96