← Product Code [JIR](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIR) · K963142 # DCA 2000 + MICROALBUMIN/CREATININE ASSAY (K963142) _Bayer Corp. · JIR · Sep 27, 1996 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIR/K963142 ## Device Facts - **Applicant:** Bayer Corp. - **Product Code:** [JIR](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIR.md) - **Decision Date:** Sep 27, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.1645 - **Device Class:** Class 1 - **Review Panel:** Clinical Chemistry ## Indications for 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. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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 (219) 262-6929 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. --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIR/K963142](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIR/K963142) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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