(126 days)
GLUCOMETER ENCORE® QA+, GLUCOMETER ENCORE® QA
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No
The summary describes a blood glucose test strip and meter system, which relies on electrochemical detection of glucose. There is no mention of AI/ML terms, image processing, or data sets typically associated with AI/ML model training or testing.
No
The device is a glucometer, which measures blood glucose levels. While crucial for managing diabetes, it is a diagnostic tool providing information, not directly applying therapy or treating a condition. Its use is "as an adjunct to the care of persons with diabetes," meaning it aids in monitoring, not therapy itself.
Yes
Explanation: The "Intended Use / Indications for Use" states that the device is "for the self-monitoring of blood glucose as an adjunct to the care of persons with diabetes," which indicates its purpose in assessing a medical condition.
No
The device description explicitly states it is a physical product (test strips) used with a physical device (blood glucose meters). There is no mention of software as the primary or sole component.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the test strips are for "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 further clarifies that they are "over-the-counter home tests for glucose in blood" and are used with a blood glucose meter. This confirms the in vitro nature of the testing.
- Anatomical Site: The mention of "whole blood" as the anatomical site reinforces that a biological sample is being analyzed.
IVD devices are defined as reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This description fits the GLUCOMETER ENCORE Blood Glucose Test Strips.
N/A
Intended Use / Indications for Use
GLUCOMETER ENCORE Blood Glucose Test Strips are for the self-monitoring of blood glucose as an adjunct to the care of persons with diabetes*
Product codes
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Device Description
GLUCOMETER ENCORE Blood Glucose Test Strips are over-the-counter home tests for glucose in blood. They are for use by persons with diabetes and by healthcare professionals in home settings and in healthcare facilities. GLUCOMETER ENCORE Blood Glucose Test Strips are for use with GLUCOMETER ENCORE® Blood Glucose Meters.
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 and by healthcare professionals in home settings and 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
Assessment of GLUCOMETER ENCORE Blood Glucose Test Strips were used with the GLUCOMETER ENCORE® QA+ and GLUCOMETER ENCORE® QA Blood Glucose Meters to evaluate the performance of the systems with arterial whole blood specimens. The evaluation was carried out in the STAT Laboratories of a large U.S. medical center. Fresh arterial specimens collected from catheters and deep sticks were used.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance of the two GLUCOMETER ENCORE Systems was compared to the Accu-Chek® Advantage™ H Blood Glucose Meter and to other laboratory methods for the determination of glucose. The GLUCOMETER ENCORE Systems gave glucose results which compared well with the performance of the predicate and other comparative methods. The results of the clinical evaluation of GLUCOMETER ENCORE Blood Glucose Test Strips used with the GLUCOMETER ENCORE QA + and GLUCOMETER ENCORE QA Blood Glucose Meters on arterial blood specimens demonstrated that the device is equivalent in performance to the predicate device and suitable for use with arterial blood specimens.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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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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K964004 FEB 1
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510(k) SAFETY AND EFFECTIVENESS SUMMARY
| Prepared: | October 4, 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: | |
| Common/Usual Name: | ||
| Document Control Number: | GLUCOMETER ENCORE® Blood | |
| Glucose Test Strips (Modified) | ||
| Test for glucose in blood | ||
| K96__________ | ||
| Classification: | Division of Clinical Laboratory Devices | |
| Panel - Clinical Chemistry and Toxicology | ||
| Classification Code - 75 CFR (Hexokinase, Glucose) | ||
| Predicate Devices: | GLUCOMETER ENCORE Blood Glucose Test Strips | |
| ACCU-CHEK® ADVANTAGE™ H Blood Glucose System | ||
| (Boehringer Mannheim Corporation) | ||
| Device Description: | GLUCOMETER ENCORE Blood Glucose Test Strips are over- | |
| the-counter home tests for glucose in blood. They are for use by | ||
| persons with diabetes and by healthcare professionals in home | ||
| settings and in healthcare facilities. GLUCOMETER ENCORE | ||
| Blood Glucose Test Strips are for use with GLUCOMETER | ||
| ENCORE® Blood Glucose Meters. | ||
| Intended Use: | GLUCOMETER ENCORE Blood Glucose Test Strips are 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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Technological GLUCOMETER ENCORE Blood Glucose Test Strips are Characteristics: specific for glucose and have been referenced to give plasma/serum glucose values. The test provides a quantitative measurement of glucose in whole blood from 10 to 600 mg/dL (0.6 to 33.3 mmol/L). The GLUCOMETER ENCORE whole blood glucose test is based on the hexokinase method using dry reagent technology. Assessment of GLUCOMETER ENCORE Blood Glucose Test Strips were used Performance: with the GLUCOMETER ENCORE® QA+ and GLUCOMETER ENCORE® QA Blood Glucose Meters to evaluate the performance of the systems with arterial whole blood specimens. The evaluation was carried out in the STAT Laboratories of a large U.S. medical center. Fresh arterial specimens collected from catheters and deep sticks were used. The performance of the two GLUCOMETER ENCORE Systems was compared to the Accu-Chek® Advantage™ H Blood Glucose Meter and to other laboratory methods for the determination of glucose. The GLUCOMETER ENCORE Systems gave glucose results which compared well with the performance of the predicate and other comparative methods. The results of the clinical evaluation of GLUCOMETER Conclusion: ENCORE Blood Glucose Test Strips used with the GLUCOMETER ENCORE QA + and GLUCOMETER ENCORE QA Blood Glucose Meters on arterial blood specimens demonstrated that the device is equivalent in performance to the predicate device and suitable for use with arterial blood specimens.