IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULIN

K963974 · Beckman Instruments, Inc. · DEW · Mar 6, 1997 · Immunology

Device Facts

• Record ID: K963974
• Device Name: IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULIN
• Applicant: Beckman Instruments, Inc.
• Product Code: DEW · Immunology
• Decision Date: Mar 6, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5510
• Device Class: Class 2

Intended Use

The IMMAGE Immunochemistry System Urine Immunoglobulin G (IGU) reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Urine Protein Calibrator, is intended for the quantitative determination of Immunoglobulin G in urine by rate nephelometry.

Device Story

The IMMAGE Immunochemistry System Urine Immunoglobulin G (IGU) reagent is an in vitro diagnostic reagent used with the Beckman IMMAGE Immunochemistry System. It utilizes rate nephelometry to measure Immunoglobulin G (IgG) concentrations in human urine. The system processes samples automatically, incorporating an integrated antigen excess testing solution within the reagent cartridge to ensure measurement accuracy. The device is intended for use in clinical laboratory settings by trained personnel. Results are provided to clinicians to assist in the assessment of renal function and protein excretion. The system improves workflow efficiency compared to manual off-line preparation methods required by previous predicate systems.

Clinical Evidence

Bench testing only. Method comparison study (n=115) against the predicate device yielded a slope of 1.00, intercept of 0.00, and r=0.998. Within-run imprecision studies (n=80 per level) showed %CVs of 10.2% at 0.38 mg/dL, 2.7% at 2.66 mg/dL, and 2.7% at 5.20 mg/dL. Stability data supports a 24-month shelf-life, 14-day open container stability, and 14-day calibration stability.

Technological Characteristics

Rate nephelometry assay; goat-derived anti-IgG antibodies; integrated antigen excess testing solution; reagent cartridge form factor; automated processing on IMMAGE Immunochemistry System.

Indications for Use

Indicated for the quantitative determination of Immunoglobulin G in human urine samples.

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

• Beckman Immunoglobulin G (IGG) Test System (Urine application) (K951635)

Submission Summary (Full Text)

{0}

200 South Kraemer Boulevard, Box 8000, Brea, CA 92822-8000 • [phone]
K963974
MMR - 6 1997

# BECKMAN

Summary of Safety & Effectiveness
IMMAGE™ Immunochemistry System Urine Immunoglobulin G (IGU) 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:

30 September 1996

## 3.0 Device Name(s):

### 3.1 Proprietary Name

IMMAGE™ Immunochemistry System Urine Immunoglobulin G (IGU) Reagent

### 3.2 Classification Name

Immunoglobulins A, G, M, D, and E immunological test system (21 CFR § 866.5510)

## 4.0 Predicate Device(s):

Beckman Immunoglobulin G (IGG) Test System (Urine application) K951635

## 5.0 Description:

The IMMAGE Immunochemistry System Urine Immunoglobulin G (IGU) reagent, in conjunction with Beckman's Urine Protein Calibrator, is intended for use in the quantitative determination of Immunoglobulin G in human urine samples.

## 6.0 Intended Use:

The IMMAGE Immunochemistry System Urine Immunoglobulin G (IGU) reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Urine Protein Calibrator, is intended for the quantitative determination of Immunoglobulin G in urine by rate nephelometry.

file: igu510k.sse
Beckman Instruments, Inc.
twx: 910-592-1260 • telex: 06-78413

{1}

Beckman Instruments, Inc., Section 510(k) Notification
IMMAGE™ Immunochemistry System Urine Immunoglobulin G (IGU) 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
IGU Reagent | Analytic Range | Same as
Beckman IGG Test System
reagent |
| | Nephelometric methodology | |
| | Antibody source (goat) | |
| DIFFERENCES | | |
| IMMAGE System
IGU Reagent | Antigen excess testing | IMMAGE IGU has antigen
excess testing solution
included in the reagent
cartridge, while the Beckman
IGG Test System requires off-
line preparation of the
solution. |
| | Antibody concentration | IMMAGE IGU has a higher
antibody concentration than
the Beckman IGG Test
System |

file: igu510k.sse

{2}

Beckman Instruments, Inc., Section 510(k) Notification
IMMAGE™ Immunochemistry System Urine Immunoglobulin G (IGU) 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 Beckman Immunoglobulin G Test System Reagent to the IMMAGE IGU Reagent.

### Method Comparison Study Results
IMMAGE IGU Reagent vs. Beckman Immunoglobulin G Kit Reagent

| Analyte | Slope | Intercept | r | n | Predicate |
| --- | --- | --- | --- | --- | --- |
| IMMAGE IGU Reagent | 1.00 | 0.00 | 0.998 | 115 | Beckman (IGG) Test System |

### Stability Study Results

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

### Estimated Within-Run Imprecision

| MATERIAL | MEAS (mg/dL) | SD (mg/dL) | %CV | Number of Results |
| --- | --- | --- | --- | --- |
| IGU Reagent | | | | |
| Level 1 | 0.38 | 0.038 | 10.2 | 80 |
| Level 2 | 2.66 | 0.071 | 2.7 | 80 |
| Level 3 | 5.20 | 0.140 | 2.7 | 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: igu510k.sse