IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ACID GLYCOPROTEIN (AAG) REAGENT

K964257 · Beckman Instruments, Inc. · LKL · Mar 24, 1997 · Immunology

Device Facts

• Record ID: K964257
• Device Name: IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ACID GLYCOPROTEIN (AAG) REAGENT
• Applicant: Beckman Instruments, Inc.
• Product Code: LKL · Immunology
• Decision Date: Mar 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5420
• Device Class: Class 1

Intended Use

The IMMAGE Immunochemistry System Alpha₁-Acid Glycoprotein (AAG) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 1, is intended for the quantitative determination of human alpha₁-acid glycoprotein by rate nephelometry.

Device Story

The IMMAGE Immunochemistry System AAG Reagent is an in vitro diagnostic reagent used on the Beckman IMMAGE Immunochemistry System. It utilizes rate nephelometry to measure alpha₁-acid glycoprotein concentrations in human serum. The system processes samples by mixing them with specific reagents, including goat-derived antibodies, to form immune complexes that scatter light. The degree of light scattering is measured to quantify the analyte concentration. The device is intended for use in clinical laboratory settings by trained personnel. Results are used by clinicians to assess alpha₁-acid glycoprotein levels, which may aid in the evaluation of inflammatory states or other clinical conditions. The system provides automated quantitative results, facilitating clinical decision-making.

Clinical Evidence

Bench testing only. Method comparison study (n=141) against the predicate on the Array® 360 system showed a slope of 0.954, intercept of 1.62, and r=0.994. Within-run imprecision studies (n=80 per level) demonstrated %C.V. values of 1.2% to 1.9% across three concentration levels. Stability studies support a 24-month shelf-life and 14-day open container/calibration stability.

Technological Characteristics

Rate nephelometry principle. Reagents utilize goat-derived antibodies. System is designed for automated quantitative analysis on the IMMAGE Immunochemistry platform. Technical specifications include specific reagent/buffer volumes and antibody concentrations optimized for the IMMAGE system.

Indications for Use

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

Regulatory Classification

Identification

An alpha-1-glycoproteins immunological test system is a device that consists of the reagents used to measure by immunochemical techniques alpha-1-glycoproteins (a group of plasma proteins found in the alpha-1 group when subjected to electrophoresis) in serum and other body fluids. Measurement of specific alpha-1-glycoproteins may aid in the diagnosis of collagen (connective tissue) disorders, tuberculosis, infections, extensive malignancy, and diabetes.

Predicate Devices

• Beckman Alpha₁-Acid Glycoprotein Reagent (K791341)

Reference Devices

• Array® 360 (used in method comparison)

Submission Summary (Full Text)

{0}

200 South Kraemer Boulevard, Box 8000, Brea, CA 92822-8000 • [phone]
K964257

# BECKMAN

Summary of Safety & Effectiveness
IMMAGE™ Immunochemistry System Alpha₁-Acid Glycoprotein (AAG) Reagent

## 1.0 Submitted By:

MAR 24 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:

24 October 1996

## 3.0 Device Name(s):

### 3.1 Proprietary Names

IMMAGE™ Immunochemistry System Alpha₁-Acid Glycoprotein (AAG) Reagent

### 3.2 Classification Name

Alpha-1-glycoproteins immunological test system (21 CFR § 866.5420)

## 4.0 Predicate Device(s):

| IMMAGE System Reagent | Predicate | Manufacturer | Docket Number |
| --- | --- | --- | --- |
| IMMAGE System Alpha₁-Acid Glycoprotein (AAG) | Beckman Alpha₁-Acid Glycoprotein Reagent | Beckman Instruments, Inc. | K791341 |

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

{1}

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

## 5.0 Description:

The IMMAGE Immunochemistry System AAG Reagent in conjunction with Beckman Calibrator 1, is intended for use in the quantitative determination of alpha₁-acid glycoprotein concentrations respectively in human serum samples on Beckman's IMMAGE Immunochemistry System.

## 6.0 Intended Use:

The IMMAGE Immunochemistry System Alpha₁-Acid Glycoprotein (AAG) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 1, is intended for the quantitative determination of human alpha₁-acid glycoprotein 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 AAG Reagent | Initial Analytic Range | Same as Beckman AAG Reagent |
| | Nephelometric methodology | |
| | Antibody source (goat) | |
| DIFFERENCES | | |
| IMMAGE System AAG Reagent | Buffer/Reagent volumes | IMMAGE System uses half of the volumes than are utilized by the Array System for AAG. |
| | Antibody concentration | IMMAGE AAG has a higher antibody concentration than the Beckman Alpha₁-Acid Glycoprotein reagent. |

file: aag510k.sse

{2}

Beckman Instruments, Inc., Section 510(k) Notification
IMMAGE™ Immunochemistry System Alpha₁-Acid Glycoprotein (AAG) 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 Reagents to the IMMAGE System Reagents.

### Method Comparison Study Results
IMMAGE Alpha-1-Acid Glycoprotein (AAG) Reagent

| Analyte | Sample Type | Slope | Intercept | r | n | Predicate Method |
| --- | --- | --- | --- | --- | --- | --- |
| IMMAGE AAG Reagent | serum | 0.954 | 1.62 | 0.994 | 141 | Beckman AAG Reagent on Array® 360 |

### Stability Study Results

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

### Estimated Within-Run Imprecision

| Sample | Mean (μg/mL) | S.D. (μg/mL) | %C.V. | N |
| --- | --- | --- | --- | --- |
| AAG | | | | |
| Level 1 | 75.5 | 1.45 | 1.9 | 80 |
| Level 2 | 183 | 2.2 | 1.2 | 80 |
| Level 3 | 251 | 3.1 | 1.2 | 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: aag510k.sse