IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ANTITRYPSIN (AAT)

K964766 · Beckman Instruments, Inc. · DEM · Apr 25, 1997 · Immunology

Device Facts

• Record ID: K964766
• Device Name: IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ANTITRYPSIN (AAT)
• Applicant: Beckman Instruments, Inc.
• Product Code: DEM · Immunology
• Decision Date: Apr 25, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5130
• Device Class: Class 2

Intended Use

The IMMAGE Immunochemistry System Alpha₁-Antitrypsin (AAT) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 2, is intended for the quantitative determination of human alpha₁-antitrypsin by rate nephelometry.

Device Story

Reagent kit for quantitative determination of alpha₁-antitrypsin in human serum; utilizes rate nephelometry on Beckman IMMAGE Immunochemistry System; requires Beckman Calibrator 2; measures light scattering to determine protein concentration; used in clinical laboratory settings by trained personnel; results assist clinicians in assessing alpha₁-antitrypsin levels; provides diagnostic information regarding potential deficiency or disease states.

Clinical Evidence

Method comparison study (n=130 serum samples) comparing IMMAGE AAT Reagent to Beckman Array Systems AAT showed slope 1.007, intercept -3.88, r=0.995. Imprecision studies (n=80 and n=30) demonstrated within-run CVs of 1.6-3.3% and total CVs of 1.6-3.7% across various serum levels. Stability data supports 24-month shelf-life and 14-day open container/calibration stability.

Technological Characteristics

Rate nephelometry; goat-derived antibody; liquid reagent; optimized for IMMAGE Immunochemistry System; utilizes automated fluidics for sample/reagent mixing; quantitative measurement based on light scattering intensity.

Indications for Use

Indicated for the quantitative determination of alpha₁-antitrypsin concentrations in human serum samples.

Regulatory Classification

Identification

An alpha-1-antitrypsin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the alpha-1-antitrypsin (a plasma protein) in serum, other body fluids, and tissues. The measurements aid in the diagnosis of several conditions including juvenile and adult cirrhosis of the liver. In addition, alpha-1-antitrypsin deficiency has been associated with pulmonary emphysema.

Predicate Devices

• Beckman Alpha₁-Antitrypsin (AAT) (K771603)

Reference Devices

• Beckman Array 360 System

Submission Summary (Full Text)

{0}

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

# BECKMAN

## Summary of Safety & Effectiveness
IMMAGE™ Immunochemistry System Alpha₁-Antitrypsin (AAT) 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:

26 November 1996

### 3.0 Device Name(s):

#### 3.1 Proprietary Names

IMMAGE™ Immunochemistry System Alpha₁-Antitrypsin (AAT) Reagent

#### 3.2 Classification Name

Alpha-1-antitrypsin immunological test system. (21 CFR § 866.5130)

### 4.0 Predicate Device(s):

| IMMAGE System Reagent | Predicate | Manufacturer | Docket Number |
| --- | --- | --- | --- |
| IMMAGE System Alpha₁-Antitrypsin (AAT) | Beckman Alpha₁-Antitrypsin (AAT) | Beckman Instruments, Inc. | K771603 |

### 5.0 Description:

The IMMAGE Immunochemistry System AAT Reagent in conjunction with Beckman Calibrator 2, is intended for use in the quantitative determination of alpha₁-antitrypsin concentrations in human serum samples on Beckman's IMMAGE Immunochemistry System.

Beckman Instruments, Inc.
fax: [phone] • telex: 06-78413

{1}

Beckman Instruments, Inc., Section 510(k) Notification
IMMAGE™ Immunochemistry System Alpha₁-Antitrypsin (AAT) Reagent
Summary of Safety & Effectiveness
2

## 6.0 Intended Use:

The IMMAGE Immunochemistry System Alpha₁-Antitrypsin (AAT) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 2, is intended for the quantitative determination of human alpha₁-antitrypsin 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 AAT Reagent | Analytic Range | Same as Beckman Alpha₁-Antitrypsin reagent |
| | Nephelometric methodology | |
| | Antibody source (goat) | |
| DIFFERENCES | | |
| IMMAGE System AAT Reagent | Buffer/Reagent volumes | IMMAGE System uses half of the volumes than are utilized by the Array System for AAT. |
| | Antibody concentration | IMMAGE AAT has a higher antibody concentration than the Beckman Alpha₁-Antitrypsin reagent |

## 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 Alpha₁-Antitrypsin (AAT) Reagent

| Analyte | Sample Type | Slope | Intercept | r | n | Predicate Method |
| --- | --- | --- | --- | --- | --- | --- |
| IMMAGE AAT Reagent | serum | 1.007 | -3.88 | 0.995 | 130 | Beckman Array Systems AAT |

file: aat510k.sse

{2}

Beckman Instruments, Inc., Section 510(k) Notification
IMMAGE™ Immunochemistry System Alpha₁-Antitrypsin (AAT) Reagent
Summary of Safety & Effectiveness
3

# Stability Study Results

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

## Estimated Imprecision

| TYPE OF PRECISION | SAMPLE | Data Points* | Test Mean Value (mg/dL) | SD (mg/dL) | % CV |
| --- | --- | --- | --- | --- | --- |
| Within Run | Serum Level 1 | 80 | 70.1 | 1.87 | 2.7 |
| | Serum Level 2 | 80 | 296 | 6.2 | 2.1 |
| | Serum Level 3 | 80 | 509 | 15.9 | 3.1 |
| Total | Serum Level 1 | 80 | 70.1 | 2.33 | 3.3 |
| | Serum Level 2 | 80 | 296 | 8.2 | 2.8 |
| | Serum Level 3 | 80 | 509 | 16.4 | 3.2 |
| TYPE OF PRECISION | SAMPLE | Data Points* | Test Mean Value (mg/dL) | SD (mg/dL) | % CV |
| --- | --- | --- | --- | --- | --- |
| Within Run | Low Serum Level 1 | 30 | 10.9 | 0.36 | 3.3 |
| | Low Serum Level 2 | 30 | 44.3 | 0.72 | 1.6 |
| Total | Low Serum Level 1 | 30 | 10.9 | 0.40 | 3.7 |
| | Low Serum Level 2 | 30 | 44.3 | 0.73 | 1.6 |

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: aat510k.sse