IMMULITE ACTH CONTROL MODULE (LACCM)

K963240 · Diagnostic Products Corp. · JJX · Aug 29, 1996 · Clinical Chemistry

Device Facts

• Record ID: K963240
• Device Name: IMMULITE ACTH CONTROL MODULE (LACCM)
• 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

Indications for Use

DPC's IMMULITE ACTH Control Module is an assayed, bi-level control intended for use with DPC's IMMULITE ACTH assay. It is intended strictly for in vitro diagnostic use.

Device Story

IMMULITE ACTH Control Module; assayed, bi-level quality control material. Used in clinical laboratory settings to monitor performance/accuracy of DPC IMMULITE ACTH assay. Provides known reference values for comparison against patient sample results. Assists laboratory personnel in verifying assay stability and identifying potential analytical errors. Benefits patient by ensuring reliability of ACTH test results used for clinical decision-making.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Assayed, bi-level liquid control material. Designed for use with IMMULITE ACTH immunoassay system. No specific materials, energy sources, or software algorithms described.

Indications for Use

Indicated for in vitro diagnostic use as an assayed, bi-level quality control material to monitor the performance of the DPC IMMULITE ACTH assay.

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.

Submission Summary (Full Text)

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Diagnostic Products Corporation
5700 West 96th Street
Los Angeles, CA 90045
Tel: [phone]
Fax: [phone]
AUG 29 1996
K963240

# 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.
Director of Clinical Affairs |
| **Date of Preparation:** | August 15, 1996 |
| **Device Name:** | IMMULITE ACTH Control Module |
| **Trade:** | Device intended as an aid in monitoring the performance of DPC's IMMULITE ACTH assay. |
| **Catalog Number:** | LACCM |
| **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:** | Quality Control Material |
| **Intended Use of the Device:** | DPC's IMMULITE ACTH Control Module is an assayed, bi-level control intended for use with DPC's IMMULITE ACTH assay. It is 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.
Director of Clinical Affairs
8/12/96
Date