TUMOR MARKER CONTROL

K965114 · Diagnostic Products Corp. · JJY · Feb 20, 1997 · Clinical Chemistry

Device Facts

• Record ID: K965114
• Device Name: TUMOR MARKER CONTROL
• Applicant: Diagnostic Products Corp.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Feb 20, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

DPC's Tumor Marker Control Module is an assayed, tri-level control intended for use with DPC's tumor marker assays. It is intended strictly for in vitro diagnostic use.

Device Story

Assayed, tri-level quality control material; used to monitor performance of DPC tumor marker assays; in vitro diagnostic use; provides reference values for assay validation; ensures analytical consistency in clinical laboratory settings.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Assayed, tri-level liquid control material. Manufactured under ISO 9002/EN29002/BS 5750 quality systems.

Indications for Use

Indicated for use as an assayed, tri-level quality control material to monitor the performance of DPC's tumor marker assays in an in vitro diagnostic 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

• DPC's PSA Control Module (K962975)

Submission Summary (Full Text)

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Diagnostic Products Corporation
Tumor Marker Control Module
December 16, 1996
K 965114

# FEB 20 1997

# 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.
Director of Clinical Affairs |
| Date of Preparation: | December 16, 1996 |
| Device Name: | Tumor Marker Control |
| Trade: | Device intended as an aid in monitoring the performance of DPC's tumor marker assays. |
| Catalog Number: | TMCO |
| Classification: | Class I device, 75-JJY (21 CFR 862.1660) |
| Manufacturer: | EURO/DPC Ltd., a wholly-owned subsidiary of DPC Glyn Rhonwy
Llanberis, Gwynedd LL55 4EL
United Kingdom
(Manufacturing under a Quality System-ISO 9002/EN29002/BS 5750) |
| Sole U.S. Importer: | Diagnostic Products Corporation (DPC)
5700 West 96th Street
Los Angeles, CA 90045-5597 |
| Establishment Registration #: | EURO/DPC: Not Applicable
DPC: 2017183 |
| Substantially Equivalent Predicate Device: | DPC's PSA Control Module (K962975) |
| Description of Device: | Quality Control Material |
| Intended Use of the Device: | DPC's Tumor Marker Control Module is an assayed, tri-level control intended for use with DPC's tumor marker assays. It is intended strictly for in vitro diagnostic use. |
| Clinical Studies: | Not applicable |