IMMAGE IMMUNOCHEMISTRY SYSTEM CERULOPLASMIN (CER) REAGENT

K964762 · Beckman Instruments, Inc. · DDB · Apr 25, 1997 · Immunology

Device Facts

• Record ID: K964762
• Device Name: IMMAGE IMMUNOCHEMISTRY SYSTEM CERULOPLASMIN (CER) REAGENT
• Applicant: Beckman Instruments, Inc.
• Product Code: DDB · Immunology
• Decision Date: Apr 25, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5210
• Device Class: Class 2

Indications for Use

The IMMAGE Immunochemistry System Ceruloplasmin (CER) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 2, is intended for the quantitative determination of human ceruloplasmin by rate nephelometry.

Device Story

The IMMAGE Immunochemistry System Ceruloplasmin (CER) Reagent is an in vitro diagnostic reagent used on the Beckman IMMAGE Immunochemistry System. It utilizes rate nephelometry to measure ceruloplasmin concentrations in human serum. The system processes samples by reacting them with goat-derived anti-ceruloplasmin antibodies; the resulting light scattering is measured to quantify the analyte. The device is intended for use in clinical laboratory settings by trained laboratory personnel. The output provides quantitative ceruloplasmin levels, which assist clinicians in assessing patient health status and diagnosing relevant clinical conditions.

Clinical Evidence

Bench testing only. Performance was validated through method comparison, stability, and imprecision studies. Method comparison against the Array 360 System (n=104) yielded a slope of 0.996, intercept of -2.43, and r=0.995. Imprecision studies (n=80 per level) demonstrated within-run CVs of 2.4-3.1% and total CVs of 3.5-4.3% for serum levels 13.6-88.0 mg/dL. Low-level precision (n=30) showed total CVs of 3.9-6.6%. Shelf-life and stability claims are 24 months and 14 days, respectively.

Technological Characteristics

Rate nephelometry-based immunochemistry reagent. Uses goat-derived anti-ceruloplasmin antibodies. Designed for use on the Beckman IMMAGE Immunochemistry System. Reagent volumes and antibody concentrations are optimized for the IMMAGE platform compared to the predicate Array system.

Indications for Use

Indicated for the quantitative determination of ceruloplasmin concentrations in human serum samples to aid in the diagnosis of ceruloplasmin-related conditions.

Regulatory Classification

Identification

A ceruloplasmin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ceruloplasmin (copper-transporting serum protein) in serum, other body fluids, or tissues. Measurements of ceruloplasmin aid in the diagnosis of copper metabolism disorders.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

Predicate Devices

• Beckman Ceruloplasmin (CER) (K791339)

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 Ceruloplasmin (CER) Reagent

### App 25 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:

26 November 1996

#### 3.0 Device Name(s):

3.1 Proprietary Names
IMMAGE™ Immunochemistry System Ceruloplasmin (CER) Reagent

3.2 Classification Name
Ceruloplasmin immunological test system (21 CFR § 866.5210)

#### 4.0 Predicate Device(s):

| IMMAGE System Reagent | Predicate | Manufacturer | Docket Number |
| --- | --- | --- | --- |
| IMMAGE System Ceruloplasmin (CER) | Beckman Ceruloplasmin (CER) | Beckman Instruments, Inc. | K791339 |

#### 5.0 Description:

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

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

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

## 6.0 Intended Use:

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

| Analyte | Sample Type | Slope | Intercept | r | n | Predicate Method |
| --- | --- | --- | --- | --- | --- | --- |
| IMMAGE CER Reagent | serum | 0.996 | -2.43 | 0.995 | 104 | Beckman Array Systems CER Reagent |

file: cer510k.sse

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Beckman Instruments, Inc., Section 510(k) Notification
IMMAGE™ Immunochemistry System Ceruloplasmin (CER) Reagent
Summary of Safety & Effectiveness
3

## Stability Study Results

| Reagent | Product Claim |
| --- | --- |
| IMMAGE CER | 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 | 13.6 | 0.42 | 3.1 |
| | Serum Level 2 | 80 | 49.3 | 1.20 | 2.4 |
| | Serum Level 3 | 80 | 88.0 | 2.72 | 3.1 |
| Total | Serum Level 1 | 80 | 13.6 | 0.52 | 3.8 |
| | Serum Level 2 | 80 | 49.3 | 1.74 | 3.5 |
| | Serum Level 3 | 80 | 88.0 | 3.76 | 4.3 |
| TYPE OF PRECISION | SAMPLE | Data Points | Test Mean Value (mg/dL) | SD (mg/dL) | % CV |
| --- | --- | --- | --- | --- | --- |
| Within Run | Low Serum Level 1 | 30 | 1.4 | 0.08 | 5.8 |
| | Low Serum Level 2 | 30 | 4.3 | 0.17 | 3.9 |
| Total | Low Serum Level 1 | 30 | 1.4 | 0.09 | 6.6 |
| | Low Serum Level 2 | 30 | 4.3 | 0.17 | 3.9 |

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: cer510k.sse