← Product Code [CGA](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGA) · K964630 # GLUCOMETER ELITE BLOOD GLUCOSE METER (K964630) _Bayer Corp. · CGA · Feb 10, 1997 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGA/K964630 ## Device Facts - **Applicant:** Bayer Corp. - **Product Code:** [CGA](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGA.md) - **Decision Date:** Feb 10, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.1345 - **Device Class:** Class 2 - **Review Panel:** Clinical Chemistry ## Indications for Use The GLUCOMETER ELITE Blood Glucose Meter is for the Self-Monitoring of Blood Glucose as an adjunct to the care of persons with diabetes. ## Device Story Electrochemical blood glucose meter; uses dry reagent sensors (test strips) to measure glucose levels. Operated by patients or healthcare professionals in home/clinical settings. Modified electronics reduce result time (60s to 30s); expanded operating range (20-600 mg/dL); increased memory (20 results); improved calibration/temperature correction. Provides quantitative glucose concentration output to assist diabetes management. ## Clinical Evidence Clinical evaluation conducted at three sites comparing modified meter to predicate device. Participants included diabetics and healthcare professionals. Results demonstrated equivalent performance. ## Technological Characteristics Electrochemical sensing principle; dry reagent test strips. Modified electronics; ROM capacity increased to 20 results; operating range 20-600 mg/dL. Features improved calibration and temperature correction algorithms. Form factor modified with top-loading test slot. ## 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 Meter (manufactured by Kyoto Daiichi Kagaku Co., Ltd.) ## 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} K964630 Bayer Corporation, Business Group Diagnostics GLUCOMETER ELITE® Blood Glucose Meter 510(k) Safety and Effectiveness Summary Page 1 of 2 FEB 10 1997 # 510(k) SAFETY AND EFFECTIVENESS SUMMARY Prepared: November 18, 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 ELITE® Blood Glucose Meter Common/Usual Name: Blood Glucose Meter Document Control Number: K96 Classification: Division of Clinical Laboratory Devices Panel - Clinical Chemistry and Toxicology Classification Code - 75 CGA (Glucose Oxidase, Glucose) Predicate Device: GLUCOMETER ELITE® Blood Glucose Meter Manufactured by Kyoto Daiichi Kagaku Co., Ltd. of Kyoto, Japan Device Description: The GLUCOMETER ELITE System consists of an electrochemical method-based meter and dry reagent sensors (test strips) designed for testing glucose by persons with diabetes or by healthcare professionals in the home or in healthcare facilities. Intended Use: The GLUCOMETER ELITE Blood Glucose Meter is for the Self-Monitoring of Blood Glucose as an adjunct to the care of persons with diabetes.* * "Consensus Statement on Self-Monitoring of Blood Glucose," Diabetes Care, Vol. 10, No. 1, January-February 1987, pp. 95-99. {1} Bayer Corporation, Business Group Diagnostics GLUCOMETER ELITE® Blood Glucose Meter 510(k) Safety and Effectiveness Summary Page 2 of 2 ## Technological Characteristics: The electronics of the GLUCOMETER ELITE Blood Glucose Meter have been modified to reduce the time for obtaining a result from 60 to 30 seconds. The operating range has been expanded from 40 - 500 mg/dL to 20 - 600 mg/dL. The capacity of the read only memory (ROM) has been increased from retaining 10 results to 20 and improvements in calibration and temperature correction have been implemented. In addition, cosmetic changes to the case give the meter a new appearance and the test slot has been moved from the left side to the top of the meter. ## Assessment of Performance: An evaluation of the modified GLUCOMETER ELITE Blood Glucose Meter was conducted at three clinical sites to demonstrate the equivalence of the modified meter to the currently used GLUCOMETER ELITE Blood Glucose Meter, the predicate device, in the hands of diabetics and healthcare professionals. ## Conclusion: The results of the evaluation of the GLUCOMETER ELITE Blood Glucose Meter demonstrate that the modified meter is equivalent in performance to the predicate device and suitable for its intended use. --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGA/K964630](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGA/K964630) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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