(83 days)
GLUCOMETER ELITE® Blood Glucose Meter
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No
The document describes a standard electrochemical blood glucose meter and test strips, with no mention of AI or ML technologies in the device description, intended use, or performance studies.
No
Explanation: A therapeutic device is used to treat a disease or condition. This device is described as being for "Self-Monitoring of Blood Glucose as an adjunct to the care of persons with diabetes," which indicates it is for monitoring and not for treatment.
Yes
The GLUCOMETER ELITE Blood Glucose Meter is used for the Self-Monitoring of Blood Glucose, which provides information for the care of persons with diabetes, indicating its role in diagnosing or monitoring a medical condition.
No
The device description explicitly states the system consists of a meter and test strips, which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "Self-Monitoring of Blood Glucose as an adjunct to the care of persons with diabetes." This involves testing a biological sample (blood) outside of the body to provide information for medical purposes (managing diabetes).
- Device Description: The description mentions "electrochemical method-based meter and dry reagent sensors (test strips) designed for testing glucose." This describes the components used to perform a test on a biological sample.
- Testing Location: The device is intended for use "in the home or in healthcare facilities," which are typical settings for IVD testing.
The core function of the device is to analyze a biological sample (blood) in vitro (outside the body) to provide diagnostic information (blood glucose levels) for the management of a medical condition (diabetes). This aligns perfectly with the definition of an In Vitro Diagnostic device.
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Intended Use / 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. *
Product codes
75 CGA
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
persons with diabetes or by healthcare professionals in the home or in healthcare facilities.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
GLUCOMETER ELITE® Blood Glucose Meter
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1345 Glucose test system.
(a)
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.(b)
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.
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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.
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Bayer Corporation, Business Group Diagnostics
GLUCOMETER ELITE® Blood Glucose Meter
| 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. |
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