IMMAGE IMMUNOCHEMISTRY SYSTEM MICROALBUMIN (MA) REAGENT

K965035 · Beckman Instruments, Inc. · JIQ · Apr 17, 1997 · Clinical Chemistry

Device Facts

• Record ID: K965035
• Device Name: IMMAGE IMMUNOCHEMISTRY SYSTEM MICROALBUMIN (MA) REAGENT
• Applicant: Beckman Instruments, Inc.
• Product Code: JIQ · Clinical Chemistry
• Decision Date: Apr 17, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1645
• Device Class: Class 1

Intended Use

The IMMAGE Immunochemistry System Microalbumin (MA) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Urine Protein Calibrator, is intended for the quantitative determination of micro quantities of albumin in urine by rate nephelometry.

Device Story

The IMMAGE Immunochemistry System MA Reagent is an in vitro diagnostic reagent used on the Beckman IMMAGE Immunochemistry System. It utilizes rate nephelometry to measure microalbumin concentrations in human urine. The system processes samples by reacting them with goat-derived antibodies; the resulting light scattering is measured to quantify albumin levels. The device is intended for use in clinical laboratory settings by trained personnel. It automates antigen excess testing by including the testing solution directly within the reagent cartridge, unlike the predicate which required manual preparation. The output provides quantitative albumin results, which clinicians use to evaluate renal health and monitor for microalbuminuria. The system improves workflow efficiency through integrated reagent management and higher antibody concentrations compared to the predicate.

Clinical Evidence

Bench testing only. Performance was validated through method comparison, stability, and imprecision studies. Method comparison against the predicate (n=109) yielded a slope of 0.957, intercept of -0.03, and r=0.991. Imprecision studies (n=80 per level) demonstrated within-run %CV ranging from 2.0% to 7.5% and total imprecision %CV ranging from 2.3% to 9.8%. Stability claims include 24-month shelf-life, 14-day open container stability, and 14-day calibration stability.

Technological Characteristics

Rate nephelometry-based immunochemistry reagent. Uses goat-derived antibodies. Features integrated antigen excess testing solution within the reagent cartridge. Designed for use on the Beckman IMMAGE Immunochemistry System. No specific materials of construction or software architecture details provided.

Indications for Use

Indicated for the quantitative determination of microalbumin in human urine samples to assist in the assessment of renal function.

Regulatory Classification

Identification

A urinary protein or albumin (nonquantitative) test system is a device intended to identify proteins or albumin in urine. Identification of urinary protein or albumin (nonquantitative) is used in the diagnosis and treatment of disease conditions such as renal or heart diseases or thyroid disorders, which are characterized by proteinuria or albuminuria.

Predicate Devices

• Beckman MA Microalbumin Reagent Kit (K895883)

Reference Devices

• Array® 360 System

Submission Summary (Full Text)

{0}

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

# BECKMAN

K965035

Summary of Safety & Effectiveness

IMMAGE™ Immunochemistry System Microalbumin (MA) Reagent

APR 17 1997

## 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 Microalbumin (MA) Reagent

### 3.2 Classification Name

Albumin immunological test system (21 CFR § 866.5040)

## 4.0 Predicate Device(s):

| IMMAGE System Reagent | Predicate | Manufacturer | Docket Number |
| --- | --- | --- | --- |
| IMMAGE System Microalbumin (MA) Reagent | Beckman MA Microalbumin Reagent Kit | Beckman Instruments, Inc. | K895883 |

Beckman Instruments, Inc.

bxc: 910-592-1260 • telex: 06-78413

{1}

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

## 5.0 Description:

The IMMAGE Immunochemistry System MA Reagent in conjunction with Beckman Urine Protein Calibrator, is intended for use in the quantitative determination of micro quantities of albumin in human urine samples on Beckman's IMMAGE™ Immunochemistry System.

## 6.0 Intended Use:

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

file: ma510k.sse

{2}

Beckman Instruments, Inc., Section 510(k) Notification
IMMAGE™ Immunochemistry System Microalbumin (MA) 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 Microalbumin (MA) Reagent

| Analyte | Sample Type | Slope | Intercept | r | n | Predicate Method |
| --- | --- | --- | --- | --- | --- | --- |
| IMMAGE MA Reagent | urine | 0.957 | -0.03 | 0.991 | 109 | Beckman MA Reagent |

### Stability Study Results

| Reagent | Product Claim |
| --- | --- |
| IMMAGE MA | 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 | 0.56 | 0.042 | 7.5 | 80 |
| Level 2 | 2.25 | 0.107 | 4.7 | 80 |
| Level 3 | 3.19 | 0.063 | 2.0 | 80 |
| Total Imprecision | | | | |
| Level 1 | 0.56 | 0.055 | 9.8 | 80 |
| Level 2 | 2.25 | 0.121 | 5.4 | 80 |
| Level 3 | 3.19 | 0.073 | 2.3 | 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: ma510k.sse