K Number
K963498
Device Name
FERR FLEX REAGENT CARTRIDGE
Date Cleared
1997-01-24

(143 days)

Product Code
Regulation Number
866.5340
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 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 anitbodies specific for ferritin and conjugate reagent consisting of B-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 Bgalactosidase is combined with a chromogenic substrate chlorophenl red-b-dgalactopyranoside (CPRG). Hydrolvsis of CPRG releases a chromophore (CPR). The color change at 577 nm is directly proportional to the concentration of ferritin in the original sample.
More Information

Not Found

Abbott IMx®

No
The device description details a standard enzyme immunoassay based on chemical reactions and optical measurement, with no mention of AI or ML algorithms for data analysis or interpretation.

No.
The device is used to measure ferritin in human samples, which is a diagnostic function, not a therapeutic one. Therapeutic devices are designed to treat or alleviate a medical condition.

Yes

The device quantitatively measures ferritin in human serum and plasma, which aids in the diagnosis and management of conditions related to ferritin levels.

No

The device is a reagent cartridge, which is a physical component used in a clinical chemistry system, not a software-only device.

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use explicitly states that the device is used to "quantitatively measure ferritin in human serum and plasma." This is a measurement performed on biological samples taken from the human body.
  • Device Description: The description details a laboratory test ("one-step enzyme immunoassay") that analyzes a biological sample ("human serum and plasma") to detect and quantify a specific substance ("ferritin").
  • Mechanism: The mechanism involves chemical reactions and measurements performed in vitro (outside the living body) on the sample.

These characteristics align directly with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.

N/A

Intended Use / 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.

Product codes

Not Found

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 anitbodies specific for ferritin and conjugate reagent consisting of B-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 Bgalactosidase is combined with a chromogenic substrate chlorophenl red-b-dgalactopyranoside (CPRG). Hydrolvsis of CPRG releases a chromophore (CPR). The color change at 577 nm is directly proportional to the concentration of ferritin in the original sample.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

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Summary of Performance Studies

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.

Key Metrics

Correlation coefficient of 0.983, slope of 0.98, and an intercept of -0.8 ng/mL.

Predicate Device(s)

Abbott Laboratories IMx® Ferritin

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 866.5340 Ferritin immunological test system.

(a)
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.(b)
Classification. Class II (performance standards).

0

Image /page/0/Picture/0 description: The image shows the word "DADE" in a bold, sans-serif font. The letters are large and black, contrasting with the white background. The letters are evenly spaced and aligned horizontally. The image is clear and easy to read.

K963498

DADE DITENELLI AND

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 anitbodies specific for ferritin and conjugate reagent consisting of B-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 Bgalactosidase is combined with a chromogenic substrate chlorophenl red-b-dgalactopyranoside (CPRG). Hydrolvsis 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.

1

Comparison to Predicate Device:

ltemDimension® RxL FerritinImx® Ferritin
TechnologySandwich format
monoclonal antibody
immunoassaySandwich format
monoclonal antibody
immunoassay
DetectionColorimetric rate
measurement at 577nm
and 700nmFluorometric 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.

G. "Bola

Cathy P. Craft Regulatory Affairs and Compliance Manager Date:12/03/96