← Product Code [CGA](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGA) · K963500 # GLUCOMETER DEX DIABETES CARE SYSTEM (K963500) _Bayer Corp. · CGA · Jan 21, 1997 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGA/K963500 ## Device Facts - **Applicant:** Bayer Corp. - **Product Code:** [CGA](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGA.md) - **Decision Date:** Jan 21, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.1345 - **Device Class:** Class 2 - **Review Panel:** Clinical Chemistry ## Indications for Use The GLUCOMETER DEX Diabetes Care System is for the self-monitoring of blood glucose as an adjunct to the care of persons with diabetes. ## Device Story System comprises blood glucose meter, test sensor discs, and control solutions; measures blood glucose via amperometric glucose oxidase method; intended for OTC home use by diabetics and professional use in clinical settings; provides quantitative blood glucose results; aids in diabetes management; results referenced to plasma glucose; linear range 10-600 mg/dL. ## Clinical Evidence In-house and clinical studies conducted by healthcare professionals and persons with diabetes; demonstrated results substantially equivalent to current blood glucose monitoring methods. ## Technological Characteristics Amperometric glucose oxidase biosensor; linear range 10-600 mg/dL; results referenced to plasma glucose; test sensor discs packaged in sets of ten. ## Regulatory Identification A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. ## Special Controls *Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. ## Predicate Devices - GLUCOMETER ELITE® Blood Glucose Monitoring System - YSI Model 2300 STAT Plus Analyzer - ACA® Discrete Clinical Analyzer - Hitachi 704 chemistry analyzer - Hitachi 747 chemistry analyzer ## 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} JAN 21 1997 K963500 page 1 of 2 # 510(k) SAFETY AND EFFECTIVENESS SUMMARY Prepared: August 30, 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: GLUCOMETER® DEX™ Diabetes Care System Common/Usual Name: Test for glucose in blood Blood glucose meter Control material Document Control Number: K96 Classification: Division of Clinical Laboratory Devices Panel - Clinical Chemistry and Toxicology Classification Code - 75 CGA (Glucose Oxidase, Glucose) Predicate Devices: GLUCOMETER ELITE® Blood Glucose Monitoring System; YSI Model 2300 STAT Plus Analyzer; ACA® Discrete Clinical Analyzer; Hitachi 704 chemistry analyzer; Hitachi 747 chemistry analyzer. Device Description: The GLUCOMETER DEX Diabetes Care System consists of the GLUCOMETER® DEX™ Blood Glucose Meter; GLUCOMETER® DEX™ Blood Glucose Test Sensor Disc; and the GLUCOMETER® DEX™ Controls (Normal, Low and High). The GLUCOMETER DEX Diabetes Care System is an over-the- counter (OTC) home test for glucose in blood. It is for use by persons with diabetes and by healthcare professionals in home settings and in healthcare facilities. {1} Bayer Corporation, Business Group Diagnostics GLUCOMETER® DEX™ Diabetes Care System S&E Summary page 2 of 2 Intended Use: The GLUCOMETER DEX Diabetes Care System is for the self-monitoring of blood glucose as an adjunct to the care of persons with diabetes.* Technological Characteristics: The GLUCOMETER DEX Diabetes Care System employs an amperometric glucose oxidase method to measure glucose in blood. It is conceptually the same as other blood glucose monitoring products available for blood glucose testing. The test sensor discs are individually sealed in a package of ten. Blood glucose results are referenced to plasma glucose. The System has a linear response to glucose from 10 - 600 mg/dL. Assessment of Performance: The performance of the GLUCOMETER DEX Diabetes Care System was studied in-house and in clinical settings by healthcare professionals and by persons with diabetes. The studies demonstrated that users can obtain blood glucose results that are substantially equivalent to current methods for blood glucose. Conclusion: The results of in-house and clinical evaluations of the GLUCOMETER DEX Diabetes Care System demonstrate that the device is equivalent in performance to the predicate devices and suitable for its intended use. * "Consensus Statement on Self-Monitoring of Blood Glucose," Diabetes Care, Vol. 10, No. 1, January-February 1987, pp. 95-99. --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGA/K963500](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGA/K963500) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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