CANTROL IRON/TIBC CONTROLS, LEVEL 1 AND LEVEL 2 PRODUCT NUMBERS: LEVEL 1: IIBC-91 AND LEVEL 2: IIBC-92

K964640 · Canyon Diagnostics, Inc. · JJY · Dec 13, 1996 · Clinical Chemistry

Device Facts

• Record ID: K964640
• Device Name: CANTROL IRON/TIBC CONTROLS, LEVEL 1 AND LEVEL 2 PRODUCT NUMBERS: LEVEL 1: IIBC-91 AND LEVEL 2: IIBC-92
• Applicant: Canyon Diagnostics, Inc.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Dec 13, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

CANTROL Iron/TIBC Controls provide a simple, but effective, method for the performance of intra- or inter- laboratory quality control in the quantitation of Serum Iron and Total Iron Binding Capacity.

Device Story

CANTROL Iron/TIBC Controls; human serum-based control material; used for intra- or inter-laboratory quality control; monitors performance of Serum Iron and TIBC assays; processed identically to patient samples; provides verification of testing procedure accuracy and precision; used by laboratory personnel in clinical settings.

Clinical Evidence

Bench testing only; stability demonstrated via real-time (short-term) and accelerated (long-term) testing protocols; precision performance validated through replicate analyses.

Technological Characteristics

Human serum-based control material; liquid/reconstituted form; intended for use with standard clinical chemistry analyzers for iron/TIBC quantitation.

Indications for Use

Indicated for use as a quality control material for monitoring the accuracy and precision of Serum Iron and Total Iron Binding Capacity (TIBC) testing procedures in clinical laboratories.

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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CANYON DIAGNOSTICS, INC.
4075 Leaverton Court • Anaheim, CA 92807
714-632-8711 • FAX [phone] • 800-445-1146

K964640
DEC 13 1996

Document Mail Center (HFZ-401)
Center for Devices and Radiological Health
Food And Drug Administration
9200 Corporate Boulevard
Rockville, MD 20850

# 510(k) Submission Summary


This summary regarding the enclosed 510(k) submission is intended to support safety and effectiveness information in accordance with requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.

CANTROL Iron/TIBC Controls provide a simple, but effective, method for the performance of intra- or inter- laboratory quality control in the quantitation of Serum Iron and Total Iron Binding Capacity.

CANTROL Iron/TIBC Controls are manufactured from human serum and provide a means for monitoring Serum Iron and TIBC testing procedures by the use of control materials in a manner identical to patient samples. CANTROL Iron/TIBC Control materials are equivalent to other human serum based chemistry control products.

Testing of CANTROL Iron/TIBC Control material was accomplished to demonstrate short term and long term product stability. Short term stability was demonstrated by real time product storage. Long term stability was conducted by an accelerated testing protocol as described in the submission data.

Product precision performance was demonstrated through replicate analyses in the conductance during stability testing.

Submitted by:
Anthony Falkowski
Owner
Canyon Diagnostics
4075 Leaverton Court
Anaheim, CA 92807
[phone]

Date:
11-15-96