DCA 2000 + MICROALBUMIN/CREATININE ASSAY

K963142 · Bayer Corp. · JIR · Sep 27, 1996 · Clinical Chemistry

Device Facts

• Record ID: K963142
• Device Name: DCA 2000 + MICROALBUMIN/CREATININE ASSAY
• Applicant: Bayer Corp.
• Product Code: JIR · Clinical Chemistry
• Decision Date: Sep 27, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1645
• Device Class: Class 1

Intended Use

The DCA 2000+ Microalbumin/Creatinine Assay is a professional use device for the measurement of microalbumin, creatinine and albumin/creatinine ratio in urine. Testing for microalbuminuria (low concentrations of albumin in the urine) is recommended in patients with insulin-dependent diabetes mellitus (IDDM) as well as patients with non-insulin dependent diabetes mellitus (NIDDM). This assay is intended for use in both screening for, and monitoring treatment of, microalbuminuria.

Device Story

System measures microalbumin, creatinine, and albumin/creatinine ratio in urine samples; utilizes reagent cartridge system with DCA 2000+ Analyzer; performs automated reaction control, measurement, and calculation; results displayed on instrument screen; intended for point-of-care use in physician offices, clinics, and hospitals by professional staff; factory-calibrated; provides quantitative data for clinical assessment of microalbuminuria; aids in screening and monitoring diabetic patients.

Clinical Evidence

Clinical performance evaluated in decentralized, point-of-care settings by typical users. Results compared to currently used laboratory methods for microalbumin and creatinine. Studies demonstrated that point-of-care users obtain results substantially equivalent to current clinical laboratory methods.

Technological Characteristics

Reagent cartridge system; immunoassay for microalbumin; alkaline colorimetric assay for creatinine; factory-calibrated; automated measurement and calculation via DCA 2000+ Analyzer; point-of-care form factor.

Indications for Use

Indicated for patients with insulin-dependent diabetes mellitus (IDDM) or non-insulin dependent diabetes mellitus (NIDDM) for screening and monitoring of microalbuminuria.

Regulatory Classification

Identification

A urinary protein or albumin (nonquantitative) test system is a device intended to identify proteins or albumin in urine. Identification of urinary protein or albumin (nonquantitative) is used in the diagnosis and treatment of disease conditions such as renal or heart diseases or thyroid disorders, which are characterized by proteinuria or albuminuria.

Predicate Devices

• Incstar Antibody Reagent Set for Microalbumin SPQ Test System
• Diagnostic Products Corporation Double Antibody Albumin RIA
• Pharmacia Albumin RIA
• Behring Turbitimer semiautomated method
• Beckman Array nephelometric method
• Roche Reagent for CREATININE (Roche Cobas-Mira)
• Automated Jaffe methods for Hitachi, Olympus and Dupont Dimension analyzers
• Sigma manual alkaline picrate method

Submission Summary (Full Text)

{0}

K963142
SEP 27 1996
page 1 of 2

# 510(k) SAFETY AND EFFECTIVENESS SUMMARY

Prepared: August 9, 1996

Submitter: Bayer Corporation, Business Group Diagnostics

Address: 1884 Miles Avenue, P. O. Box 70
Elkhart, IN 46515
[phone]

Contact: Rosanne M. Savol, R.A.C.
Manager, Regulatory Affairs

Device: Trade/Proprietary Name: DCA 2000®+ Microalbumin/Creatinine Assay
Common/Usual Name: Test for microalbumin in urine
Test for creatinine in urine
Document Control Number: K96

Classification: Division of Clinical Laboratory Devices
Panel - Clinical Chemistry and Toxicology
Classification Code - 75 JIR (Urinary Protein or Albumin)
75 CGX (Alkaline Picrate, Colorimetry, Creatinine)

Predicate Devices: Incstar® Antibody Reagent Set for Microalbumin SPQ™ Test System; Diagnostic Products Corporation Double Antibody Albumin RIA for microalbuminuria; Pharmacia Albumin RIA; Behring Turbitimer semiautomated method for albumin; Beckman Array® nephelometric method for albumin; Roche® Reagent for CREATININE [Roche Cobas™-Mira]; automated Jaffe methods for Hitachi, Olympus and Dupont Dimension analyzers; Sigma manual alkaline picrate method

Device Description: The DCA 2000+ Microalbumin/Creatinine Assay is a convenient, quantitative method for measuring low concentrations of albumin (microalbumin), creatinine and albumin/creatinine ratio in urine. The DCA 2000+ Microalbumin/Creatinine Assay is designed to be used with the DCA 2000+ Analyzer and the

{1}

Bayer Corporation, Business Group Diagnostics
DCA 2000®+ Microalbumin/Creatinine Assay
S&E Summary page 2 of 2

DCA 2000+ Microalbumin/Creatinine Control Kit. It is self-contained reagent/instrument system that is suitable for use in decentralized, or point-of-care laboratories such as physician office laboratories, clinics and hospitals.

## Intended Use:

The DCA 2000+ Microalbumin/Creatinine Assay is a professional use device for the measurement of microalbumin, creatinine and albumin/creatinine ratio in urine. Testing for microalbuminuria (low concentrations of albumin in the urine) is recommended in patients with insulin-dependent diabetes mellitus (IDDM) as well as patients with non-insulin dependent diabetes mellitus (NIDDM). This assay is intended for use in both screening for, and monitoring treatment of, microalbuminuria.

## Technological Characteristics:

The DCA 2000+ Microalbumin/Creatinine Assay employs an immunoassay for the microalbumin test and an alkaline, colorimetric assay for the creatinine test. The reagents are contained in a reagent cartridge. The DCA 2000+ Analyzer controls the reaction steps and automatically performs all the measurements and calculations. Results are displayed on the instrument screen. The system is factory calibrated.

## Assessment of Performance:

The performance of the DCA 2000+ Microalbumin/Creatinine Assay was studied in clinical settings by typical users of the system and results compared to currently used tests for microalbumin and creatinine. The studies demonstrated that typical users in decentralized, point-of-care laboratories can obtain clinical test results that are substantially equivalent to current methods.

## Conclusion:

The DCA 2000+ Microalbumin/Creatinine Assay is a convenient method for measuring microalbumin and creatinine in urine. Studies show that it can be used in decentralized and point-of-care laboratories and provide clinical results comparable to other test methods in current clinical laboratory practice.