IMMAGE SYSTEM RHEUMATOID FACTOR (RF) REAGENT

K963048 · Beckman Instruments, Inc. · DHR · Nov 4, 1996 · Immunology

Device Facts

• Record ID: K963048
• Device Name: IMMAGE SYSTEM RHEUMATOID FACTOR (RF) REAGENT
• Applicant: Beckman Instruments, Inc.
• Product Code: DHR · Immunology
• Decision Date: Nov 4, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5775
• Device Class: Class 2

Intended Use

The IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) reagent, in conjunction with Beckman Cal 5 Plus, is intended for use in the quantitative determination of human rheumatoid factor concentrations in human serum and plasma samples by rate nephelometry. This assay is designed for use with the IMMAGE Immunochemistry System.

Device Story

The IMMAGE Immunochemistry System RF Reagent is a liquid-stable, latex-enhanced reagent used on the IMMAGE Immunochemistry System. It measures rheumatoid factor (RF) concentrations in human serum or plasma samples via rate nephelometry. The system uses latex particle technology to detect RF; the instrument measures light scattering to quantify the analyte. It is intended for use in clinical laboratory settings by trained laboratory personnel. The output provides quantitative RF concentration values, which clinicians use to assist in the diagnosis and management of rheumatoid arthritis. The liquid-stable format offers improved stability compared to lyophilized alternatives.

Clinical Evidence

Bench testing only. Method comparison study against Behring N Latex RF showed a slope of 1.055, intercept of 0.41, and r=0.940. Imprecision studies (n=80 per level) demonstrated %CVs of 2.1% (124 IU/mL), 1.5% (299 IU/mL), and 1.9% (637 IU/mL). Stability studies confirmed a 24-month shelf-life and 14-day open-container stability.

Technological Characteristics

Latex-enhanced rate nephelometry assay. Liquid-stable reagent format. Designed for use on the IMMAGE Immunochemistry System. Quantitative measurement of RF concentrations in serum/plasma.

Indications for Use

Indicated for the quantitative determination of rheumatoid factor concentrations in human serum and plasma samples to aid in the diagnosis of rheumatoid arthritis.

Regulatory Classification

Identification

A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.

Predicate Devices

• Behring Diagnostics N Latex RF (K942328)

Submission Summary (Full Text)

{0}

200 South Kraemer Boulevard, Box 8000, Brea, CA 92622-8000 • [phone]

NOV 4 1996

BECKMAN

K963048

Summary of Safety & Effectiveness

IMMAGE™ Immunochemistry System Rheumatoid Factor (RF) Reagent

1.0 Submitted By:

Annette Hellie
Regulatory Specialist, Product Submissions
Beckman Instruments, Inc.
200 S. Kraemer Blvd., W-337
Brea, California 92822-8000
Telephone: [phone]
FAX: [phone]

2.0 Date Submitted:

05 Aug-1996

3.0 Device Name(s):

3.1 Proprietary Names

IMMAGE™ Immunochemistry System Rheumatoid Factor (RF) Reagent

3.2 Classification Names

Rheumatoid factor immunological test system(21 CFR 866.5775)

4.0 Predicate Device(s):

Behring Diagnostics N Latex RF, K942328

5.0 Description:

The IMMAGE Systems Rheumatoid Factor (RF) Reagent is designed for optimal performance on the IMMAGE Immunochemistry System. It is intended for use in the quantitative determination of human rheumatoid factor concentrations in human serum and plasma samples.

6.0 Intended Use:

The IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) reagent, in conjunction with Beckman Cal 5 Plus, is intended for use in the quantitative determination of human rheumatoid factor concentrations in human serum and plasma samples by rate nephelometry. This assay is designed for use with the IMMAGE Immunochemistry System.

file: irf510k.see

Beckman Instruments, Inc.

twx: 910-592-1260 • telex: 06-78413

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

# 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 RF Reagent | Intended use | Same as Behring N Latex RF |
| IMMAGE System RF Reagent | Nephelometric methodology | Same as Behring N Latex RF |
| IMMAGE System RF Reagent | Latex particle technology | Same as Behring N Latex RF |
| DIFFERENCES | | |
| IMMAGE System RF Reagent | Form of reagent | IMMAGE RF is a liquid stable reagent, while Behring N Latex RF is lyophilized. |
| IMMAGE System RF Reagent | Stability | IMMAGE RF reagent is stable for 14 days once opened, properly stored, while Behring N Latex RF reagent is stable for one week following reconstitution |

file: irf510k.sse

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Beckman Instruments, Inc., Section 510(k) Notification
IMMAGE™ Immunochemistry System Rheumatoid Factor (RF) 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 the Behring N Latex RF Reagent to the IMMAGE System RF Reagent.

### Method Comparison Study Results
IMMAGE RF Reagent vs. Behring N Latex RF Reagent

| Analyte | Slope | Intercept | r | Predicate |
| --- | --- | --- | --- | --- |
| IMMAGE RF | 1.055 | 0.41 | 0.940 | Behring N Latex RF |

### Stability Study Results

| Reagent | Product Claim |
| --- | --- |
| IMMAGE RF | 24 months shelf-life
14 day open container
14 day calibration |

### Estimated Within-Run Imprecision

| MATERIAL | MEAN (IU/mL) | SD (IU/mL) | %CV | Number of Results |
| --- | --- | --- | --- | --- |
| IMMAGE System RF Reagent | | | | |
| Level 1 | 124 | 2.5 | 2.1 | 80 |
| Level 2 | 299 | 4.5 | 1.5 | 80 |
| Level 3 | 637 | 12.4 | 1.9 | 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.

file: irf510k.sse