IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN A-1 REAGENT (APA)/ IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN B REAGENT

K964010 · Beckman Instruments, Inc. · MSJ · Feb 10, 1997 · Clinical Chemistry

Device Facts

• Record ID: K964010
• Device Name: IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN A-1 REAGENT (APA)/ IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN B REAGENT
• Applicant: Beckman Instruments, Inc.
• Product Code: MSJ · Clinical Chemistry
• Decision Date: Feb 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1475
• Device Class: Class 1

Intended Use

The IMMAGE Immunochemistry System Apolipoprotein A-1 (APA) and B (APB) Reagents, in conjunction with Beckman Apolipoprotein Calibrator (APO Cal), are intended for use in the quantitative determination of apolipoprotein A-1 and B in human serum samples by nephelometric immunoassay. These assays are designed for use with the IMMAGE Immunochemistry System.

Device Story

Reagents for IMMAGE Immunochemistry System; used for quantitative determination of apolipoprotein A-1 and B in human serum. Principle of operation: rate nephelometric immunoassay. System measures light scatter to determine analyte concentration. Used in clinical laboratory settings by trained personnel. Output provided as concentration values (mg/dL) to healthcare providers for clinical assessment of lipid profiles and cardiovascular risk. Benefits include automated, standardized measurement of apolipoproteins compared to manual or older system methods.

Clinical Evidence

Bench testing only. Method comparison study against predicate devices on the ARRAY system showed high correlation (r=0.983 for APA, r=0.991 for APB). Within-run imprecision (n=80) demonstrated %CVs ranging from 2.5% to 5.5% across three concentration levels for both analytes. Stability studies confirmed 24-month shelf-life and 14-day on-board/calibration stability.

Technological Characteristics

Rate nephelometry assay. Reagents supplied in plastic cartridges. Reaction temperature 37°C. Quantitative measurement range: APA (25-450 mg/dL), APB (35-450 mg/dL). Designed for use on the IMMAGE Immunochemistry System.

Indications for Use

Indicated for the quantitative determination of apolipoprotein A-1 and B concentrations in human serum samples to assess lipoprotein levels.

Regulatory Classification

Identification

A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

Predicate Devices

• Beckman Immunochemistry Systems Apolipoprotein A-1 Reagent (K862019)
• Beckman Immunochemistry Systems Apolipoprotein B Reagent (K862386)

Submission Summary (Full Text)

{0}

200 South Kraemer Boulevard, Box 8000, Brea, CA 92822-8000 • [phone]
FEB 10 1997

# BECKMAN
## K964010

### Summary of Safety & Effectiveness
IMMAGE™ Immunochemistry System Apolipoprotein A-1 (APA) and B (APB) Reagents

### 1.0 Submitted By:

Margie George
Project Manager, Systems Development
Beckman Instruments, Inc.
200 S. Kraemer Blvd., W-337
Brea, California 92822-8000
Telephone: [phone]
FAX: [phone]

### 2.0 Date Submitted:

03 Oct 1996

### 3.0 Device Name(s):

#### 3.1 Proprietary Names

IMMAGE™ Immunochemistry System Apolipoprotein A-1 Reagent
IMMAGE™ Immunochemistry System Apolipoprotein B Reagent

#### 3.2 Classification Names

Lipoprotein test system (21 CFR 862.1475)

### 4.0 Predicate Device(s):

Beckman Immunochemistry Systems Apolipoprotein A-1 Reagent, K862019
Beckman Immunochemistry Systems Apolipoprotein B Reagent, K 862386

### 5.0 Description:

The IMMAGE System Apolipoprotein A-1 (APA) and B (APB) Reagents are designed for optimal performance on the IMMAGE Immunochemistry System. They are intended for use in the quantitative determination of apolipoprotein A-1 and B concentrations in human serum samples.

### 6.0 Intended Use:

The IMMAGE Immunochemistry System Apolipoprotein A-1 (APA) and B (APB) Reagents, in conjunction with Beckman Apolipoprotein Calibrator (APO Cal), are intended for use in the quantitative determination of apolipoprotein A-1 and B in human serum samples by nephelometric immunoassay. These assays are designed for use with the IMMAGE Immunochemistry System.

file: APO510k.sse
Beckman Instruments, Inc.
twx: 910-592-1260 • telex: 06-78413

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Beckman Instruments, Inc., Section 510(k) Notification
IMMAGE™ Immunochemistry System Apolipoprotein A-1(APA) and B (APB) Reagents
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 APA Reagent | Assay method - rate nephelometry | Same as Beckman Immunochemistry Systems Apolipoprotein A-1 Reagent |
| | Sample/reagent ratios | |
| | Measuring Range:
Initial 25 - 255 mg/dL
Extended 25 - 450 mg/dL | |
| | Antibody | |
| DIFFERENCES | | |
| IMMAGE System APA Reagent | Reaction Temperature | IMMAGE System APA assay runs at 37°C and the predicate runs at 26.7°C. |
| | Reagent Container | IMMAGE reagent is stored in a plastic cartridge and the predicate reagent is stored in glass vials. |
| Reagent | Aspect/Characteristic | Comments |
| --- | --- | --- |
| SIMILARITIES | | |
| IMMAGE System APB Reagent | Assay method - rate nephelometry | Same as Beckman Immunochemistry Systems Apolipoprotein B Reagent |
| | Sample/reagent ratios | |
| | Measuring Range:
Initial 35 - 255 mg/dL
Extended 35 - 450 mg/dL | |
| | Antibody | |
| DIFFERENCES | | |
| IMMAGE System APB Reagent | Reaction Temperature | IMMAGE System APB assay runs at 37°C and the predicate runs at 26.7°C. |
| | Reagent Container | IMMAGE reagent is stored in a plastic cartridge and the predicate reagent is stored in glass vials. |

file: APO510k.sse

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Beckman Instruments, Inc., Section 510(k) Notification
IMMAGE™ Immunochemistry System Apolipoprotein A-1(APA) and B (APB) Reagents
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 Immunochemistry Systems Apolipoprotein A-1 and B Reagents to the IMMAGE APA & APB Reagents.

### Method Comparison Study Results
IMMAGE APA & APB Reagents vs. Beckman Apolipoprotein A-1 and B Reagents

| Analyte | Slope | Intercept | r | Predicate |
| --- | --- | --- | --- | --- |
| IMMAGE APA | 0.998 | 1.86 | 0.983 | Beckman Apolipoprotein A-1 Reagent on the ARRAY |
| IMMAGE APB | 1.030 | -1.34 | 0.991 | Beckman Apolipoprotein B Reagent on the ARRAY |

### Stability Study Results

| Reagent | Product Claim |
| --- | --- |
| IMMAGE APA | 24 months shelf-life
14-day on board
14 day calibration stability |
| IMMAGE APB | 24 months shelf-life
14 open container stability
14 day calibration stability |

### Estimated Within-Run Imprecision

| Material | MEAN (mg/dL) | SD (mg/dL) | %CV | Number of Results |
| --- | --- | --- | --- | --- |
| APA Reagent | | | | |
| Level 1 | 56.7 | 3.12 | 5.5 | 80 |
| Level 2 | 105 | 3.4 | 3.2 | 80 |
| Level 3 | 167 | 4.8 | 2.9 | 80 |
| APB Reagent | | | | |
| Level 1 | 55.7 | 1.78 | 3.2 | 80 |
| Level 2 | 115 | 2.9 | 2.5 | 80 |
| Level 3 | 186 | 4.6 | 2.5 | 80 |

file: APO510k.sse

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Beckman Instruments, Inc., Section 510(k) Notification
IMMAGE™ Immunochemistry System Apolipoprotein A-1(APA) and B (APB) Reagents
Summary of Safety & Effectiveness

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: APO510k.sse