IMMAGE IMMUNOCHEMISTRY SYSTEM PREALBUMIN (PAB) REAGENT

K964781 · Beckman Instruments, Inc. · DDS · May 9, 1997 · Immunology

Device Facts

• Record ID: K964781
• Device Name: IMMAGE IMMUNOCHEMISTRY SYSTEM PREALBUMIN (PAB) REAGENT
• Applicant: Beckman Instruments, Inc.
• Product Code: DDS · Immunology
• Decision Date: May 9, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5060
• Device Class: Class 1

Intended Use

The IMMAGE Immunochemistry System Prealbumin (PAB) reagent, in conjunction with Beckman Calibrator 3, is intended for use in the quantitative determination of human prealbumin concentrations in human serum samples by rate nephelometry. This assay is designed for use with the Beckman IMMAGE Immunochemistry System.

Device Story

The IMMAGE Immunochemistry System Prealbumin (PAB) Reagent is an in vitro diagnostic reagent kit used with the Beckman IMMAGE Immunochemistry System. It utilizes rate nephelometry to measure prealbumin concentrations in human serum samples. The system processes samples by reacting them with goat-derived antibodies; the resulting light scattering is measured to determine analyte concentration. The device is intended for clinical laboratory use. Results are provided to healthcare providers to assist in the quantitative assessment of prealbumin levels in patient serum, aiding in clinical decision-making regarding nutritional status or other relevant clinical conditions.

Clinical Evidence

Bench testing only. Method comparison study (n=124) comparing IMMAGE PAB to ARRAY PAB showed a slope of 0.992, intercept of -0.307, and r=0.985. Precision studies (n=80 per level) demonstrated within-run CVs of 1.6-2.0% and total precision CVs of 1.8-2.3%. Stability data supports 24-month shelf-life and 14-day open container/calibration stability.

Technological Characteristics

Rate nephelometry assay; goat-derived antibody; reagent kit includes cartridge, evaporation caps, and lot-specific bar code card. Operates at 37°C. Analytical range 7.0-50 mg/dL; extended range 1.17-1800 mg/dL. Designed for use on the Beckman IMMAGE Immunochemistry System.

Indications for Use

Indicated for the quantitative determination of human prealbumin concentrations in human serum samples to assess prealbumin levels.

Regulatory Classification

Identification

A prealbumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the prealbumin (a plasma protein) in serum and other body fluids. Measurement of prealbumin levels in serum may aid in the assessment of the patient's nutritional status.

Predicate Devices

• Beckman Immunochemistry Systems PAB Prealbumin Reagent

Submission Summary (Full Text)

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Beckman Instruments, Inc., Section 510(k) Notification
IMMAGE™ Immunochemistry System Prealbumin (PAB) Reagent
Summary of Safety & Effectiveness
K964781
May 9, 1997

# Summary of Safety & Effectiveness
## IMMAGE™ Immunochemistry System Prealbumin (PAB) Reagent

### 1.0 Submitted By:

Frank Marte, R.A.C.
Sr. Regulatory Affairs Specialist
Beckman Instruments, Inc.
200 S. Kraemer Blvd., W-337
Brea, California 92822-8000
Telephone: [phone]
FAX: [phone]

### 2.0 Date Submitted:

22 November 1996

### 3.0 Device Name(s):

#### 3.1 Proprietary Names

IMMAGE™ Immunochemistry System Prealbumin (PAB) Reagent

#### 3.2 Classification Names

Prealbumin immunological test system (21 CFR 866.5060)

### 4.0 Predicate Device(s):

Beckman Immunochemistry Systems PAB Prealbumin Reagent

### 5.0 Description:

The IMMAGE Immunochemistry System Prealbumin (PAB) Reagent, in conjunction with Beckman Calibrator 3, is intended for use in the quantitative determination of human prealbumin concentrations in human serum samples. The reagent kit contains one cartridge of reagent, evaporation caps and a lot specific bar code card. Calibrators and control materials are purchased separately.

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

## 6.0 Intended Use:

The IMMAGE Immunochemistry System Prealbumin (PAB) reagent, in conjunction with Beckman Calibrator 3, is intended for use in the quantitative determination of human prealbumin concentrations in human serum samples by rate nephelometry. This assay is designed for use with the Beckman IMMAGE Immunochemistry System.

## 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 (PAB) Reagent | Assay method - rate nephelometry ☑ | Same as Beckman's Immunochemistry System Prealbumin PAB Reagent as run on the ARRAY® System |
| | Serum:
Analytic Range: 7.0 - 50 mg/dL ☑
Extended Range: 1.17 - 1800 mg/dL | |
| | Sample and reagent ratios ☑ | |
| | Antibody source (goat) ☑ | |
| | Shelf life of 24 months ☑
(stored at 2 -8°C) | |
| DIFFERENCES | | |
| IMMAGE System (PAB) Reagent | Reaction Temperature | IMMAGE System PAB assays run at 37°C and the predicate runs at 26.7°C |
| | Buffer/Reagent Volume | IMMAGE System PAB Reagent uses one half the volume utilized by the Array System for the PAB assay |

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Beckman Instruments, Inc., Section 510(k) Notification
IMMAGE™ Immunochemistry System Prealbumin (PAB) 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 Immunochemistry System PAB Prealbumin (on ARRAY) Reagent to the IMMAGE System PAB Reagent.

### Method Comparison Study Results
IMMAGE PAB Reagent vs.
Beckman Prealbumin Reagent (PAB) on ARRAY

| Analyte | Sample Type | Slope | Intercept | r | n | Predicate |
| --- | --- | --- | --- | --- | --- | --- |
| IMMAGE PAB | Serum | 0.992 | -0.307 | 0.985 | 124 | Beckman Prealbumin Reagent (PAB) on the ARRAY® Systems |

### Stability Study Results

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

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

# Precision Study Results
## IMMAGE PAB Reagent

| Material
Serum | Mean
(mg/dL) | SD (mg/dL) | %CV | N |
| --- | --- | --- | --- | --- |
| Within Run Precision | | | | |
| Level 1 | 16.4 | 0.29 | 1.8 | 80 |
| Level 2 | 25.5 | 0.51 | 2.0 | 80 |
| Level 3 | 44.7 | 0.72 | 1.6 | 80 |
| Total Precision | | | | |
| Level 1 | 16.4 | 0.33 | 2.0 | 80 |
| Level 2 | 25.5 | 0.59 | 2.3 | 80 |
| Level 3 | 44.7 | 0.81 | 1.8 | 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.

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