← Product Code [JMG](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JMG) · K963498

# FERR FLEX REAGENT CARTRIDGE (K963498)

_Dade Chemistry Systems, Inc. · JMG · Jan 24, 1997 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-f%E2%80%94immunological-test-systems/JMG/K963498

## Device Facts

- **Applicant:** Dade Chemistry Systems, Inc.
- **Product Code:** [JMG](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JMG.md)
- **Decision Date:** Jan 24, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5340
- **Device Class:** Class 2
- **Review Panel:** Immunology

## Indications for 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).

## Regulatory 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.

![img-0.jpeg](img-0.jpeg)

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-f%E2%80%94immunological-test-systems/JMG/K963498](https://fda.innolitics.com/submissions/CH/subpart-f%E2%80%94immunological-test-systems/JMG/K963498)

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