FERR FLEX REAGENT CARTRIDGE

K963498 · Dade Chemistry Systems, Inc. · JMG · Jan 24, 1997 · Immunology

Device Facts

• Record ID: K963498
• Device Name: FERR FLEX REAGENT CARTRIDGE
• Applicant: Dade Chemistry Systems, Inc.
• Product Code: JMG · Immunology
• Decision Date: Jan 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5340
• Device Class: Class 2

Intended Use

The FERR Flex™ reagent cartridge is used on the Dimension™ RxL clinical chemistry system to quantitatively measure ferritin in human serum and plasma.

Device Story

Ferritin Flex™ Reagent Cartridge is a one-step enzyme immunoassay for use on the Dimension™ RxL clinical chemistry system. Input: human serum or plasma sample. Principle: sandwich immunoassay using monoclonal antibodies coated on chromium dioxide particles and β-galactosidase labeled monoclonal antibodies. Process: sample incubation forms particle-ferritin-conjugate sandwich; magnetic separation and washing remove unbound components; chromogenic substrate (CPRG) added; hydrolysis releases chromophore (CPR). Output: color change measured at 577 nm, proportional to ferritin concentration. Used in clinical laboratories by technicians. Results aid clinicians in assessing iron status.

Clinical Evidence

Split-sample comparison between FERR Flex™ on Dimension® RxL and Abbott IMx® assay. Sample size: 60 clinical patient samples. Results: correlation coefficient 0.983, slope 0.98, intercept -0.8 ng/mL.

Technological Characteristics

Sandwich enzyme immunoassay; chromium dioxide particles; β-galactosidase conjugate; chromogenic substrate (CPRG); colorimetric detection at 577 nm; automated system (Dimension® RxL).

Indications for Use

Indicated for the quantitative measurement of ferritin in human serum and plasma to aid in the diagnosis and monitoring of iron deficiency or iron overload states.

Regulatory Classification

Identification

A ferritin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ferritin (an iron-storing protein) in serum and other body fluids. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency amemia.

Predicate Devices

• Abbott Laboratories IMx® Ferritin

Submission Summary (Full Text)

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DADE K9a3498
Date: 12/03/96
Interoffice Memorandum
JAN 24 1997

# Summary of Safety and Effectiveness Information

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

**Submitter's Name:** Cathy P. Craft
Dade International Inc.
P.O. Box 6101
Newark, DE 19714-6101

**Date of Preparation:** 12/03/96

**Name of Product:** Ferritin Flex™ Reagent Cartridge

**FDA Classification Name:** FerritinTest System

**Predicate Device:** Abbott Laboratories IMx® Ferritin

**Device Description:** The FERR Flex™ Reagent Cartridge is a one-step enzyme immunoassay based on the “sandwich” principle. Sample is incubated with chromium dioxide particles, coated with monoclonal antibodies specific for ferritin and conjugate reagent consisting of β-galactosidase labeled monoclonal antibodies specific for a second binding site on ferritin to form a particle-ferritin-conjugate sandwich. Unbound conjugate and analyte are removed by magnetic separation and washing. The sandwich bound β-galactosidase is combined with a chromogenic substrate chlorophenol red-b-d-galactopyranoside (CPRG). Hydrolysis of CPRG releases a chromophore (CPR). The color change at 577 nm is directly proportional to the concentration of ferritin in the original sample.

**Intended Use:** The FERR Flex™ reagent cartridge is used on the Dimension™ RxL clinical chemistry system to quantitatively measure ferritin in human serum and plasma.

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# Comparison to Predicate Device:

| Item | Dimension® RxL Ferritin | Imx® Ferritin |
| --- | --- | --- |
| Technology | Sandwich format
monoclonal antibody
immunoassay | Sandwich format
monoclonal antibody
immunoassay |
| Detection | Colorimetric rate
measurement at 577nm
and 700nm | Fluorometric endpoint
measurement |

# Comments on Substantial

Equivalence: Split sample comparison between the FERR Flex™ reagent cartridge on the Dimension® RxL clinical chemistry system and the Abbott IMx® assay gave a correlation coefficient of 0.983, slope of 0.98, and an intercept of -0.8 ng/mL when tested with 60 clinical patient samples.

Conclusion: The FERR Flex™ Reagent Cartridge is substantially equivalent in principle and performance to the Imx® Ferritin Assay based on the split sample comparison discussed above.