DIMENSION MICROALBUMIN (MALB) FLEX REAGENT CARTRIDGE METHOD, CALIBRATOR, MODELS DF114, DC114

K033525 · Dade Behring, Inc. · DCF · Jan 12, 2004 · Immunology

Device Facts

• Record ID: K033525
• Device Name: DIMENSION MICROALBUMIN (MALB) FLEX REAGENT CARTRIDGE METHOD, CALIBRATOR, MODELS DF114, DC114
• Applicant: Dade Behring, Inc.
• Product Code: DCF · Immunology
• Decision Date: Jan 12, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5040
• Device Class: Class 2

Indications for Use

The Dade Behring Dimension® Microalbumin (MALB) Flex® reagent cartridge method is an in vitro diagnostic test intended to quantitatively measure albumin in human urine. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases. Measurement also aids in the diagnosis and treatment of heart diseases or thyroid disorders which are characterized by proteinuria or albuminuria. The Dade Behring Dimension® Microalbumin Calibrator is an in vitro diagnostic device intended for use on Dade Behring Dimension® clinical chemistry systems for medical purposes to establish points of reference that are used in the determination of albumin in urine.

Device Story

The Dimension® Microalbumin (MALB) Flex® reagent cartridge is an in vitro diagnostic assay for use on Dimension® clinical chemistry systems. It utilizes a particle-enhanced turbidimetric inhibition immunoassay (PETINIA). Input: human urine sample. Principle: Albumin in the sample competes with albumin-bound latex particles for monoclonal antibody binding sites; the resulting aggregation rate is inversely proportional to the albumin concentration. Output: quantitative albumin concentration determined via bichromatic turbidimetric reading at 340 and 700 nm. The system uses a mathematical function to calculate concentration. Operated by laboratory personnel in clinical settings. Results assist clinicians in diagnosing kidney, intestinal, heart, and thyroid conditions associated with abnormal albumin levels. The calibrator (DC114) is a 5-level aqueous product used to establish reference points for the assay.

Clinical Evidence

No clinical data provided; substantial equivalence established via bench testing and analytical performance comparison with predicate assays.

Technological Characteristics

PETINIA assay; latex particles coated with human albumin; mouse monoclonal antibodies to human albumin. Bichromatic turbidimetric detection at 340 and 700 nm. Calibrator is buffered aqueous product with human albumin at 5 levels (0, 12.5, 25, 50, 110 mg/L). Designed for use on Dimension clinical chemistry systems.

Indications for Use

Indicated for quantitative measurement of albumin in human urine to aid in the diagnosis of kidney and intestinal diseases, and the diagnosis and treatment of heart diseases or thyroid disorders characterized by proteinuria or albuminuria.

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

• Dade Behring nephelometric (BN II) N Antiserum to Human Albumin assay (K972929)
• Dade Behring Urinary Albumin Calibrator (K936201)

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE ONLY TEMPLATE

A. 510(k) Number:
K033525

B. Analyte:
Urinary albumin (microalbumin)

C. Type of Test:
Quantitative particle-enhanced turbidimetric inhibition immunoassay (PETINIA)

D. Applicant:
Dade Behring, Inc.

E. Proprietary and Established Names:
Dimension® Microalbumin (MALB) Flex® reagent cartridge
Dimension® Microalbumin calibrator

F. Regulatory Information:
1. Regulation section:
21 CFR § 866.5040 (reagent)
21 CFR § 862.1150 (calibrator)
2. Classification:
Class II
3. Product Code:
DCF (reagent)
JIT (calibrator)
4. Panel:
Immunology

G. Intended Use:
1. Indication(s) for use:
The Dade Behring Dimension® Microalbumin (MALB) Flex® reagent cartridge method is an in vitro diagnostic test intended to quantitatively measure albumin in human urine. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases. Measurement also aids in the diagnosis and treatment of heart diseases or thyroid disorders which are characterized by proteinuria or albuminuria.

The Dade Behring Dimension® Microalbumin Calibrator is an in vitro diagnostic device intended for use on Dade Behring Dimension® clinical chemistry systems for medical purposes to establish points of reference that are used in the determination of albumin in urine.

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2. Special condition for use statement(s):
Prescription use only

3. Special instrument Requirements:
Dimension® clinical chemistry system only

## H. Device Description:

The MALB reagent consists of particle reagent (2 mg/mL), mouse monoclonal antibodies to human albumin (140 μg/mL), microbial inhibitors, and buffer.

The MALB Calibrator is a buffered aqueous product containing weighed-in quantities of human albumin. The calibrator is packaged as a 5-level kit at nominal albumin concentrations of 0, 12.5, 25, 50, and 110 mg/L. Quality control material is not included with the reagent and calibrator.

## I. Substantial Equivalence Information:

1. Predicate device name(s):
Dade Behring nephelometric (BN II) N Antiserum to Human Albumin assay;
Dade Behring Urinary Albumin Calibrator

2. Predicate K number(s):
K972929; K936201

3. Comparison with predicate:
| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Matrix | Urine | Urine, Serum, CSF |
| Analyzer | Same | Dade Automated Analyzer |
| Methodology | Same | Light-scattering |
| Calibrator | Human based, 5 levels | Human based, 3 levels |
| Differences | | |
| Item | Device | Predicate |
| Reportable Range | 1.3 – 100 mg/L | 2.2 – 340 mg/L |
| Sample Size | 17 μL | 80 μL |

## J. Standard/Guidance Document Referenced (if applicable):

None referenced

## K. Test Principle:

The Microalbumin (MALB) method is based on a particle-enhanced turbidimetric inhibition immunoassay (PETINIA), adapted to the Dimension® clinical chemistry system, which allows direct quantitation of albumin in urine samples. The MALB Flex® reagent cartridge contains a particle reagent (PR) consisting of latex particles with human albumin bound to the surface. Aggregates of these particles are formed when a monoclonal antibody (Ab) to human albumin is introduced. Albumin (ALB) present in the sample competes with the particles for the antibody, thereby decreasing the rate of aggregation. Hence, the rate of aggregation is inversely proportional to the concentration of albumin in the sample. The rate of aggregation is measured using bichromatic turbidimetric readings at 340 and 700 nm. The concentration is determined by means of a mathematical function.

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PR + Ab + ALB (sample)