IMMULITE THYROID AUTOANTIBODY CONTROL MODULE

K971051 · Diagnostic Products Corp. · JJX · Apr 10, 1997 · Clinical Chemistry

Device Facts

• Record ID: K971051
• Device Name: IMMULITE THYROID AUTOANTIBODY CONTROL MODULE
• Applicant: Diagnostic Products Corp.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Apr 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

IMMULITE® Thyroid Autoantibody Control Module is an assayed, bi-level control intended for use with the IMMULITE® Anti-TPO Ab assay. It is intended strictly for in vitro diagnostic use.

Device Story

Assayed, bi-level liquid control material; used to monitor performance of IMMULITE® Anti-TPO Ab assay; provides known reference values for quality control; used by laboratory technicians in clinical settings; ensures assay accuracy and reliability; supports clinical decision-making by validating diagnostic test results.

Clinical Evidence

No clinical data. Nonclinical testing performed to demonstrate safety and effectiveness.

Technological Characteristics

Assayed, bi-level liquid control material. Manufactured under ISO 9002/EN29002/BS 5750 quality systems. No electronic, software, or energy-based components.

Indications for Use

Indicated for use as an assayed, bi-level quality control material to monitor the performance of the IMMULITE® Anti-TPO Ab assay in clinical laboratory settings.

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
IMMULITE® Thyroid Autoantibody Control Module
March 21, 1997
K 971051

# 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:** March 21, 1997
**Device Name:** IMMULITE® Thyroid Autoantibody Control
**Trade:** Device intended as an aid in monitoring the performance of the IMMULITE® Anti-TPO Ab assay.

**Catalog Number:** LAACM
**Classification:** Class I device, 75-JJX (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:** IMMULITE® Thyroid Autoantibody Control
Module is an assayed, bi-level control intended for use with the IMMULITE® Anti-TPO Ab assay. It is intended strictly for *in vitro* diagnostic use.

**Clinical Studies:** Not applicable

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Diagnostic Products Corporation
IMMULITE® Thyroid Autoantibody Control Module
March 21, 1997
K971051

## 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
3/21/97
Date