IMMAGE IMMUNOCHEMISTRY SYSTEM ALBUMIN (ALB) REAGENT

K964695 · Beckman Instruments, Inc. · DCF · Apr 29, 1997 · Immunology

Device Facts

• Record ID: K964695
• Device Name: IMMAGE IMMUNOCHEMISTRY SYSTEM ALBUMIN (ALB) REAGENT
• Applicant: Beckman Instruments, Inc.
• Product Code: DCF · Immunology
• Decision Date: Apr 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5040
• Device Class: Class 2

Intended Use

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

Device Story

The IMMAGE Immunochemistry System Albumin (ALB) Reagent is an in vitro diagnostic assay used for the quantitative measurement of albumin in human serum and CSF. The device utilizes rate nephelometry to measure albumin concentrations. The reagent kit includes a cartridge, evaporation caps, and a lot-specific bar code card for system identification. It is designed for operation on the Beckman IMMAGE Immunochemistry System. The system processes samples to determine albumin levels, which aids clinicians in assessing patient health status. The device is intended for use in clinical laboratory settings by trained laboratory personnel. The output provides quantitative albumin concentration values, which healthcare providers use to support clinical decision-making regarding patient diagnosis and monitoring.

Clinical Evidence

Bench testing only. Method comparison study (n=164 serum, n=101 CSF) against predicate showed high correlation (r=0.997 for serum, r=0.994 for CSF). Precision studies for serum (n=80) showed total CVs of 1.9-2.4%; CSF (n=30) showed total CVs of 4.2-6.9%. Stability studies confirm 24-month shelf-life and 14-day open container/calibration stability.

Technological Characteristics

Rate nephelometry assay; reagent cartridge system with integrated prediluted antigen excess solution; reaction temperature 37°C. Designed for use with Beckman IMMAGE Immunochemistry System. Shelf life 24 months at 2-8°C.

Indications for Use

Indicated for quantitative determination of human albumin in serum and cerebrospinal fluid (CSF) samples.

Regulatory Classification

Identification

An albumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the albumin (a plasma protein) in serum and other body fluids. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.

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 § 866.9.

Predicate Devices

• Beckman Immunochemistry Systems ALB Albumin Reagent

Submission Summary (Full Text)

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K964695
APR 29 1997
Beckman Instruments, Inc., Section 510(k) Notification
IMMAGE™ Immunochemistry System Albumin (ALB) Reagent
Summary of Safety & Effectiveness

# Summary of Safety & Effectiveness
## IMMAGE™ Immunochemistry System Albumin (ALB) 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:

20 November 1996

### 3.0 Device Name(s):

#### 3.1 Proprietary Names

IMMAGE™ Immunochemistry System Albumin (ALB) Reagent

#### 3.2 Classification Names

Albumin immunological test system (21 CFR 866.5040)

### 4.0 Predicate Device(s):

Beckman Immunochemistry Systems ALB Albumin Reagent

### 5.0 Description:

The IMMAGE Immunochemistry System Albumin (ALB) Reagent, in conjunction with Beckman Calibrator 3, is intended for use in the quantitative determination of human albumin concentrations in human serum and cerebrospinal fluid (CSF) 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 Albumin (ALB) Reagent
Summary of Safety & Effectiveness

## 6.0 Intended Use:

The IMMAGE Immunochemistry System Albumin (ALB) reagent, in conjunction with Beckman Calibrator 3, is intended for use in the quantitative determination of human albumin concentrations in human serum and CSF 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 (ALB) Reagent | Assay method - rate nephelometry | Same as Beckman's Immunochemistry System Albumin ALB Reagent as run on the ARRAY® System |
| | Serum:
Analytic Range 800 - 6000 mg/dL
Extended Range 22.2 - 6000 mg/dL
CSF:
Analytic Range 3.7 - 27.8 mg/dL | |
| | Sample and reagent ratios | |
| | Antibody | |
| | Shelf life of 24 months
(stored at 2 -8°C) | |
| DIFFERENCES | | |
| IMMAGE System (ALB) Reagent | Reaction Temperature | IMMAGE System ALB assays run at 37°C and the predicate runs at 26.7°C |
| | Antigen excess solution (AGXS) | IMMAGE System ALB Reagent AGXS is prediluted and present in the reagent cartridge while the predicate requires off-line preparation of the solution |

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

### Method Comparison Study Results
IMMAGE ALB Reagent vs.
Beckman Albumin Reagent (ALB) on ARRAY

| Analyte | Sample Type | Slope | Intercept | r | n | Predicate |
| --- | --- | --- | --- | --- | --- | --- |
| IMMAGE ALB | Serum | 1.020 | 10.3 | 0.997 | 164 | Beckman Albumin Reagent (ALB) on the ARRAY® Systems |
| IMMAGE ALB | CSF | 0.990 | 0.692 | 0.994 | 101 | Beckman Albumin Reagent (ALB) on the ARRAY® Systems |

### Stability Study Results

| Reagent | Product Claim |
| --- | --- |
| IMMAGE ALB 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 Albumin (ALB) Reagent
Summary of Safety & Effectiveness

## Precision Study Results
### IMMAGE ALB Reagent

| Material Serum | Mean (mg/dL) | SD (md/dL) | %CV | N |
| --- | --- | --- | --- | --- |
| Within Run Precision | | | | |
| Level 1 | 2268 | 40.4 | 1.8 | 80 |
| Level 2 | 3563 | 56.6 | 1.6 | 80 |
| Level 3 | 4996 | 115.2 | 2.3 | 80 |
| Total Precision | | | | |
| Level 1 | 2268 | 55.4 | 2.4 | 80 |
| Level 2 | 3563 | 68.5 | 1.9 | 80 |
| Level 3 | 4996 | 121.2 | 2.4 | 80 |

## Precision Study Results
### IMMAGE ALB Reagent

| Material CSF | Mean (mg/dL) | SD (md/dL) | %CV | N |
| --- | --- | --- | --- | --- |
| Within Run Precision | | | | |
| Level 1 | 5.13 | 0.227 | 4.4 | 30 |
| Level 2 | 12.5 | 0.53 | 4.2 | 30 |
| Level 3 | 20.7 | 0.71 | 3.4 | 30 |
| Total Precision | | | | |
| Level 1 | 5.13 | 0.356 | 6.9 | 30 |
| Level 2 | 12.5 | 0.58 | 4.6 | 30 |
| Level 3 | 20.7 | 0.87 | 4.2 | 30 |

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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