CANTROL SERUM IRON AND TOTAL IRON BINDING CAPACITY TEST SYSTEM

K970248 · Canyon Diagnostics, Inc. · JQE · Feb 11, 1997 · Clinical Chemistry

Device Facts

• Record ID: K970248
• Device Name: CANTROL SERUM IRON AND TOTAL IRON BINDING CAPACITY TEST SYSTEM
• Applicant: Canyon Diagnostics, Inc.
• Product Code: JQE · Clinical Chemistry
• Decision Date: Feb 11, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1415
• Device Class: Class 1

Intended Use

CANTROL Serum Iron and Total Iron Binding Capacity test system provides a simple, but effective, method for quantitating the level of serum iron and total iron binding capacity in human blood serum.

Device Story

In vitro diagnostic test system; quantitates serum iron and total iron binding capacity (TIBC) in human blood serum. Procedure: acidic reagent with hydroxylamine and thiourea releases iron from transferrin; reduces iron to ferrous state; ferene chromogen reacts to form colored complex. TIBC analysis: serum saturated with iron via ion exchange resin and ferric ammonium citrate prior to iron determination. Color intensity measured spectrophotometrically; proportional to analyte concentration. Used in clinical laboratory settings by trained personnel. Results assist clinicians in assessing iron status and diagnosing iron-related disorders.

Clinical Evidence

No clinical data provided. Performance established via bench testing, including precision, linearity, and correlation studies to demonstrate equivalence to a predicate device.

Technological Characteristics

Spectrophotometric assay system. Reagents: acidic reagent (hydroxylamine, thiourea), ferene chromogen, ion exchange resin, ferric ammonium citrate. Manual or automated spectrophotometric measurement of colored complex.

Indications for Use

Indicated for the quantitative determination of serum iron and total iron binding capacity in human blood serum for diagnostic purposes.

Regulatory Classification

Identification

An iron-binding capacity test system is a device intended to measure iron-binding capacity in serum. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia.

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

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

K970248

FEB 11 1997

# 510(k) Submission Summary

This summary regarding the enclosed 501(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 Serum Iron and Total Iron Binding Capacity test system provides a simple, but effective, method for quantitating the level of serum iron and total iron binding capacity in human blood serum. The methods and procedures used in this assay protocol follow well documented, published and accepted methods for determination of the analytes as defined in the 510(k) reference section.

In the CANTROL Serum Iron procedure Iron is released from its carrier, transferrin, by an acidic reagent containing hydroxylamine and thiourea which reduces the iron to its ferrous state. A chromogen reagent, ferene, reacts with the ferrous iron to produce a colored complex, the color of which is proportional to the quantity of Iron in the test sample. Color of the reaction is measured spectrophotometrically.

Total Iron Binding Capacity analysis uses the same color reaction to test serum samples which have been saturated with iron by use of an ion exchange resin in the presence of ferric ammonium citrate, prior to the iron determination. The bound iron remaining in the serum after treatment with the resin compound is the Total Iron Binding Capacity.

Precision, Linearity and Correlation data is submitted to demonstrate product performance and substantial equivalency with another legally marketed predicate device.

Submitted by:

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

Date:
1-17-97