IMMAGE IMMUNOCHEMISTRY SYSTEM TRANSFERRIN (TRF) REAGENT

K963427 · Beckman Instruments, Inc. · DDG · Oct 7, 1996 · Immunology

Device Facts

• Record ID: K963427
• Device Name: IMMAGE IMMUNOCHEMISTRY SYSTEM TRANSFERRIN (TRF) REAGENT
• Applicant: Beckman Instruments, Inc.
• Product Code: DDG · Immunology
• Decision Date: Oct 7, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5880
• Device Class: Class 2

Intended Use

The IMMAGE Immunochemistry System Transferrin (TRF) reagent, in conjunction with Beckman Calibrator 1, is intended for use in the quantitative determination of transferrin concentrations in human serum samples by rate nephelometry.

Device Story

The IMMAGE Immunochemistry System Transferrin (TRF) Reagent is an in vitro diagnostic reagent used on the Beckman IMMAGE Immunochemistry System. It utilizes rate nephelometry to measure transferrin concentrations in human serum. The system processes samples using a reagent cartridge, evaporation caps, and a lot-specific bar code card. The assay involves an antibody-antigen reaction; the rate of light scattering is measured to determine analyte concentration. The device is intended for clinical laboratory use. Results are provided to healthcare providers to assist in clinical decision-making regarding patient iron metabolism and nutritional status.

Clinical Evidence

Bench testing only. Method comparison study between IMMAGE TRF and ARRAY system predicate showed a slope of 0.990, intercept of 0.692, and r=0.994. Within-run imprecision studies (n=80 per level) yielded %CVs of 3.1% (241 mg/dL), 3.9% (361 mg/dL), and 2.9% (653 mg/dL). Stability studies confirmed 24-month shelf-life and 14-day open-container/calibration stability.

Technological Characteristics

Rate nephelometry assay. Reagent provided in plastic cartridges. Analytical range: 75-750 mg/dL; extended range: 12.5-4,500 mg/dL. Operates at 37°C. Storage: 2-8°C.

Indications for Use

Indicated for the quantitative determination of transferrin concentrations in human serum samples to aid in the diagnosis of transferrin-related conditions.

Regulatory Classification

Identification

A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in serum, plasma, and other body fluids. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.

Predicate Devices

• Beckman Immunochemistry Systems TRF Transferrin Reagent

Reference Devices

• ARRAY® System

Submission Summary (Full Text)

{0}

OCT 7 1996
Beckman Instruments, Inc., Section 510(k) Notification
IMMAGE™ Immunochemistry System Transferrin (TRF) Reagent
Summary of Safety & Effectiveness
K963427

# Summary of Safety & Effectiveness
## IMMAGE™ Immunochemistry System Transferrin (TRF) Reagent

### 1.0 Submitted By:

Margie George
Project Manager, System Development
Beckman Instruments, Inc.
200 S. Kraemer Blvd., W-337
Brea, California 92822-8000
Telephone: [phone]
FAX: [phone]

### 2.0 Date Submitted:

30 August 1996

### 3.0 Device Name(s):

#### 3.1 Proprietary Names

IMMAGE™ Immunochemistry System Transferrin (TRF) Reagent

#### 3.2 Classification Names

Transferrin immunological test system (21 CFR 866.5880)

### 4.0 Predicate Device(s):

Beckman Immunochemistry Systems TRF Transferrin Reagent

### 5.0 Description:

The IMMAGE Immunochemistry System Transferrin (TRF) Reagent is used in the determination of transferrin concentrations in human serum samples on Beckman's IMMAGE Immunochemistry System. The reagent kit contains one cartridge of reagent, evaporation caps and a lot specific bar code card. Calibrators and control materials are purchased separately.

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{1}

Beckman Instruments, Inc., Section 510(k) Notification
IMMAGE™ Immunochemistry System Transferrin (TRF) Reagent
Summary of Safety & Effectiveness

## 6.0 Intended Use:

The IMMAGE Immunochemistry System Transferrin (TRF) reagent, in conjunction with Beckman Calibrator 1, is intended for use in the quantitative determination of transferrin concentrations in human serum samples by rate nephelometry.

## 7.0 Comparison to Predicate(s):

The following table shows similarities and differences between the predicates identified in Section 4.0 of this summary.

| Reagent | Aspect/Characteristic | Comments |
| --- | --- | --- |
| SIMILARITIES | | |
| IMMAGE System (TRF) Reagent | Assay method - rate nephelometry | Same as Beckman's Immunochemistry System Transferrin TRF Reagent as run on the ARRAY® System |
| | Analytic Range 75 - 750 mg/dL
Extended Range 12.5 - 4,500 mg/dL | |
| | Sample and reagent ratios | |
| | Antibody | |
| | Shelf life of 24 months
(stored at 2 -8°C) | |
| DIFFERENCES | | |
| IMMAGE System (TRF) Reagent | Reaction Temperature | IMMAGE System TRF assays run at 37°C and the predicate runs at 26.7°C |
| | Reagent container | IMMAGE reagent is stored in a plastic cartridge where as the predicate is stored in glass. |

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Beckman Instruments, Inc., Section 510(k) Notification
IMMAGE™ Immunochemistry System Transferrin (TRF) Reagent
Summary of Safety & Effectiveness

## 8.0 Summary of Performance Data:

The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison, stability, and imprecision experiments that relate results obtained from Beckman's Immunochemistry System TRF Transferrin (on ARRAY) Reagent to the IMMAGE System TRF Reagent.

### Method Comparison Study Results
IMMAGE TRF Reagent vs. Beckman TRF Transferrin Reagent (on ARRAY)

| Analyte | Slope | Intercept | r | Predicate |
| --- | --- | --- | --- | --- |
| IMMAGE TRF | 0.990 | 0.692 | 0.994 | Beckman's TRF Transferrin Reagent on the ARRAY® Systems |

### Stability Study Results

| Reagent | Product Claim |
| --- | --- |
| IMMAGE TRF Reagent System | 24 month shelf-life
14 day open container stability
14 day calibration stability |

### Estimated Within-Run Imprecision

| MATERIAL | MEAN (mg/dL) | SD (mg/dL) | %CV | Number of Results |
| --- | --- | --- | --- | --- |
| TRF Reagent | | | | |
| Level 1 | 241 | 7.4 | 3.1 | 80 |
| Level 2 | 361 | 14.0 | 3.9 | 80 |
| Level 3 | 653 | 18.9 | 2.9 | 80 |

This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.

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