IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-MICROGLOBULIN (AI) REAGENT

K965033 · Beckman Instruments, Inc. · MGA · Apr 21, 1997 · Immunology

Device Facts

• Record ID: K965033
• Device Name: IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-MICROGLOBULIN (AI) REAGENT
• Applicant: Beckman Instruments, Inc.
• Product Code: MGA · Immunology
• Decision Date: Apr 21, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5400
• Device Class: Class 1

Intended Use

The IMMAGE Immunochemistry System Alpha-1-Microglobulin (A1M) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Urine Protein Calibrator, is intended for the quantitative determination of alpha-1-microglobulin in urine by rate nephelometry.

Device Story

Device is an in vitro diagnostic reagent for use on the IMMAGE Immunochemistry System. It utilizes rate nephelometry to measure alpha-1-microglobulin (A1M) concentrations in human urine. The system processes samples by reacting them with goat-derived antibodies; it includes integrated antigen excess testing within the reagent cartridge. The device is intended for use in clinical laboratory settings by trained personnel. Results are provided to clinicians to assist in diagnostic decision-making regarding renal function or protein excretion. The primary benefit is the automated, quantitative measurement of A1M with improved workflow efficiency compared to manual off-line antigen excess preparation.

Clinical Evidence

Bench testing only. Method comparison study (n=123) comparing IMMAGE A1M Reagent to the predicate method yielded a slope of 0.961, intercept of 0.10, and correlation coefficient (r) of 0.993. Imprecision studies (n=80 per level) showed within-run %C.V. ranging from 1.8% to 2.8% and total imprecision %C.V. ranging from 2.0% to 4.1% across three concentration levels (0.77–6.59 mg/dL). Stability data supports a 24-month shelf-life and 14-day open-container/calibration stability.

Technological Characteristics

Rate nephelometry assay; goat-derived antibody reagent; integrated antigen excess testing solution; automated processing on IMMAGE Immunochemistry System.

Indications for Use

Indicated for the quantitative determination of alpha-1-microglobulin in human urine samples to aid in clinical assessment.

Regulatory Classification

Identification

An alpha-globulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the alpha-globulin (a serum protein) in serum and other body fluids. Measurement of alpha-globulin may aid in the diagnosis of inflammatory lesions, infections, severe burns, and a variety of other conditions.

Predicate Devices

• Beckman Alpha-1-Microglobulin A1M Reagent (K933078)

Reference Devices

• Array® 360 System

Submission Summary (Full Text)

{0}

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

# BECKMAN

APR 21 1997

$K965033$

Summary of Safety & Effectiveness

IMMAGE™ Immunochemistry System Alpha-1-Microglobulin (A1M) 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:

16 December 1996

## 3.0 Device Name(s):

### 3.1 Proprietary Names

IMMAGE™ Immunochemistry System Alpha-1-Microglobulin (A1M) Reagent

### 3.2 Classification Name

Not classified

## 4.0 Predicate Device(s):

| IMMAGE System Reagent | Predicate | Manufacturer | Docket Number |
| --- | --- | --- | --- |
| IMMAGE System Alpha-1-Microglobulin (A1M) Reagent | Beckman Alpha-1-Microglobulin A1M Reagent | Beckman Instruments, Inc. | K933078 |

Beckman Instruments, Inc.

twx: 910-592-1260 • telex: 06-78413

{1}

Beckman Instruments, Inc., Section 510(k) Notification
IMMAGE™ Immunochemistry System Alpha-1-Microglobulin (A1M) Reagent
Summary of Safety & Effectiveness

# 5.0 Description:

The IMMAGE Immunochemistry System A1M Reagent in conjunction with Beckman Urine Protein Calibrator, is intended for use in the quantitative determination of alpha-1-microglobulin in human urine samples on Beckman's IMMAGE™ Immunochemistry System.

# 6.0 Intended Use:

The IMMAGE Immunochemistry System Alpha-1-Microglobulin (A1M) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Urine Protein Calibrator, is intended for the quantitative determination of alpha-1-microglobulin in urine 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 A1M Reagent | Analytic Range | Same as Beckman Alpha-1-Microglobulin Reagent |
| | Nephelometric methodology | |
| | Antibody source (goat) | |
| DIFFERENCES | | |
| IMMAGE System A1M Reagent | Antigen excess testing | IMMAGE A1M has antigen excess testing solution included in the reagent cartridge, while the Beckman Alpha-1-Microglobulin Reagent requires off-line preparation of the solution. |
| | Antibody concentration | IMMAGE A1M has a higher antibody concentration than the Beckman Alpha-1-Microglobulin Reagent |

file: a1m510k sse

{2}

Beckman Instruments, Inc., Section 510(k) Notification
IMMAGE™ Immunochemistry System Alpha-1-Microglobulin (A1M) 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 Reagent on the Array® 360 System to the IMMAGE System Reagent.

### Method Comparison Study Results
IMMAGE Alpha-1-Microglobulin (A1M) Reagent

| Analyte | Sample Type | Slope | Intercept | r | n | Predicate Method |
| --- | --- | --- | --- | --- | --- | --- |
| IMMAGE A1M Reagent | Urine | 0.961 | 0.10 | 0.993 | 123 | Beckman Alpha-1-Microglobulin Reagent |

### Stability Study Results

| Reagent | Product Claim |
| --- | --- |
| IMMAGE A1M | 24 month shelf-life
14 day open container stability
14 day calibration stability |

### Estimated Imprecision

| Sample | Mean (mg/dL) | S.D. (mg/dL) | %C.V. | N |
| --- | --- | --- | --- | --- |
| Within-Run Imprecision | | | | |
| Level 1 | 0.77 | 0.021 | 2.8 | 80 |
| Level 2 | 3.05 | 0.056 | 1.8 | 80 |
| Level 3 | 6.59 | 0.161 | 2.4 | 80 |
| Total Imprecision | | | | |
| Level 1 | 0.77 | 0.031 | 4.1 | 80 |
| Level 2 | 3.05 | 0.061 | 2.0 | 80 |
| Level 3 | 6.59 | 0.194 | 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.

file: a1m510k.sse