IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM)

K963868 · Beckman Instruments, Inc. · DEW · Feb 10, 1997 · Immunology

Device Facts

• Record ID: K963868
• Device Name: IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM)
• Applicant: Beckman Instruments, Inc.
• Product Code: DEW · Immunology
• Decision Date: Feb 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5510
• Device Class: Class 2

Intended Use

The IMMAGE Immunochemistry System Immunoglobulin G (IGG) reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 1, is intended for the quantitative determination of human immunoglobulin G by rate nephelometry. The IMMAGE Immunochemistry System Immunoglobulin A (IGA) reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 1, is intended for the quantitative determination of human immunoglobulin A by rate nephelometry. The IMMAGE Immunochemistry System Immunoglobulin M (IGM) reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 1, is intended for the quantitative determination of human immunoglobulin M by rate nephelometry.

Device Story

Reagents for IMMAGE Immunochemistry System; perform quantitative determination of human IgG, IgA, and IgM via rate nephelometry. Input: serum or CSF samples; combined with Beckman Calibrator 1. Process: antibody-antigen reaction measured by rate nephelometry at 37°C. Output: quantitative concentration values (mg/dL). Used in clinical laboratory settings; operated by laboratory technicians. Results assist clinicians in evaluating patient immunoglobulin status.

Clinical Evidence

Bench testing only. Method comparison studies (n=247-323 per analyte) against predicate reagents showed high correlation (r=0.971-0.998). Imprecision studies (n=30-80) demonstrated %C.V. ranging from 1.3% to 5.3%. Stability data supports 24-month shelf-life and 14-day open container/calibration stability.

Technological Characteristics

Rate nephelometry; reaction temperature 37°C; antibody-based reagent formulation. System is a clinical chemistry analyzer component. No specific materials or software architecture details provided.

Indications for Use

Indicated for quantitative determination of human immunoglobulin G, A, and M in serum and/or CSF samples to assess immunoglobulin levels.

Regulatory Classification

Identification

An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

Predicate Devices

• Immunochemistry Systems Immunoglobulin G Reagent (K771603)
• Immunochemistry Systems Immunoglobulin A Reagent (K771603)
• Immunochemistry Systems Immunoglobulin M Reagent (K771603)

Submission Summary (Full Text)

{0}

200 South Kraemer Boulevard, Box 8000, Brea, CA 92822-8000 • [phone]

# BECKMAN

Summary of Safety & Effectiveness

IMMAGE™ Immunochemistry System Immunoglobulins IGG, IGA, & IGM Reagents

1.0 Submitted By:
K963868
FEB 10 1997

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:
25 September-1996

3.0 Device Name(s):

3.1 Proprietary Names
IMMAGE™ Immunochemistry System Immunoglobulin G (IGG) Reagent
IMMAGE™ Immunochemistry System Immunoglobulin A (IGA) Reagent
IMMAGE™ Immunochemistry System Immunoglobulin M (IGM) Reagent

3.2 Classification Names
Immunoglobulin G Test System (21 CFR §866.5510)
Immunoglobulin A Test System (21 CFR §866.5510)
Immunoglobulin M Test System (21 CFR §866.5510)

4.0 Predicate Device(s):

| IMMAGE System Reagent | Predicate | Manufacturer | Docket Number |
| --- | --- | --- | --- |
| Immunoglobulin G (IGG) Reagent | Immunochemistry Systems | Beckman Instruments, Inc. | K771603 |
| | Immunoglobulin G Reagent | | |
| Immunoglobulin A (IGA) Reagent | Immunochemistry Systems | Beckman Instruments, Inc. | K771603 |
| | Immunoglobulin A Reagent | | |
| | Immunochemistry Systems | | |
| Immunoglobulin M (IGM) Reagent | Immunoglobulin M Reagent | Beckman Instruments, Inc. | K771603 |

Beckman Instruments, Inc.
twx: 910-592-1260 • telex: 06-78413

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Beckman Instruments, Inc., Section 510(k) Notification
IMMAGE™ Immunochemistry System Immunoglobulins IGG, IGA, & IGM Reagents
Summary of Safety & Effectiveness

# 5.0 Description:

The IMMAGE Immunochemistry System Immunoglobulins IGG, IGA, and IGM, Reagents in conjunction with Beckman Calibrator 1, are intended for use on Beckman's IMMAGE Immunochemistry System.

# 6.0 Intended Use:

The IMMAGE Immunochemistry System Immunoglobulin G (IGG) reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 1, is intended for the quantitative determination of human immunoglobulin G by rate nephelometry.

The IMMAGE Immunochemistry System Immunoglobulin A (IGA) reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 1, is intended for the quantitative determination of human immunoglobulin A by rate nephelometry.

The IMMAGE Immunochemistry System Immunoglobulin M (IGM) reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 1, is intended for the quantitative determination of human immunoglobulin M 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 (IGG, IGA, & IGM) Reagents | Reagent antibody formulation | Same as Immunochemistry Systems (IGG, IGA, & IGM) Reagents |
| | Nephelometric rate methodology | |
| | Reagents are curve fit with the same standards | |
| DIFFERENCES | | |
| IMMAGE System (IGG, IGA, & IGM) Reagents | Antibody titer | Immunochemistry Systems (IGG, IGA, & IGM) reagents use a higher antibody titer. |
| IMMAGE System (IGG, IGA, & IGM) Reagents | Reaction Temperature | Immunochemistry Systems operate at 26°C, IMMAGE System operates at 37°C |

file: ig510k.sse

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Beckman Instruments, Inc., Section 510(k) Notification
IMMAGE™ Immunochemistry System Immunoglobulins IGG, IGA, & IGM Reagents
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 Immunochemistry Systems Reagents to the IMMAGE System Reagents.

### Method Comparison Study Results
IMMAGE System IGG, IGA, & IGM Reagents

| Analyte | Sample Type | Slope | Intercept | r | n | Predictor Method |
| --- | --- | --- | --- | --- | --- | --- |
| IMMAGE IGG Reagent | Serum | 1.037 | -16.6 | 0.971 | 323 | Immunochemistry Systems IGG Reagent |
| IMMAGE IGG Reagent | CSF | 1.037 | 0.11 | 0.985 | 100 | Immunochemistry Systems IGG Reagent |
| IMMAGE IGA Reagent | Serum | 1.031 | -2.07 | 0.990 | 289 | Immunochemistry Systems IGA Reagent |
| IMMAGE IGM Reagent | Serum | 1.001 | -4.29 | 0.998 | 247 | Immunochemistry Systems IGM Reagent |

### Stability Study Results

| Reagent | Product Claim |
| --- | --- |
| IMMAGE IGG, IGA, & IGM | 24 month shelf-life
14 day open container stability
14 day calibration stability |

file: ig510k.sse

{3}

Beckman Instruments, Inc., Section 510(k) Notification
IMMAGE™ Immunochemistry System Immunoglobulins IGG, IGA, & IGM Reagents
Summary of Safety & Effectiveness

# Estimated Within-Run Imprecision

| Sample | Mean (mg/dL) | S.D. (mg/dL) | %C.V. | N |
| --- | --- | --- | --- | --- |
| Immunoglobulin G (IGG) (Serum sample) | | | | |
| Level 1 | 549 | 10.8 | 2.0 | 80 |
| Level 2 | 1293 | 33.3 | 2.6 | 80 |
| Level 3 | 2362 | 51.2 | 2.2 | 80 |
| Sample | Mean (mg/dL) | S.D. (mg/dL) | %C.V. | N |
| --- | --- | --- | --- | --- |
| Immunoglobulin G (IGG) Reagent (CSF sample) | | | | |
| Level 1 | 1.62 | 0.086 | 5.3 | 30 |
| Level 2 | 7.85 | 0.104 | 1.3 | 30 |
| Level 3 | 13.5 | 0.52 | 3.9 | 30 |
| Sample | Mean (mg/dL) | S.D. (mg/dL) | %C.V. | N |
| --- | --- | --- | --- | --- |
| Immunoglobulin A (IGA) Reagent | | | | |
| Level 1 | 126 | 3.7 | 2.9 | 80 |
| Level 2 | 268 | 7.6 | 2.8 | 80 |
| Level 3 | 605 | 15.4 | 2.5 | 80 |
| Sample | Mean (mg/dL) | S.D. (mg/dL) | %C.V. | N |
| --- | --- | --- | --- | --- |
| Immunoglobulin M (IGM) Reagent | | | | |
| Level 1 | 53.8 | 1.56 | 2.9 | 80 |
| Level 2 | 115 | 2.7 | 2.4 | 80 |
| Level 3 | 334 | 10.6 | 3.2 | 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: ig510k.sse