(126 days)
GLUCOMETER ENCORE Blood Glucose Test Strips are for the self-monitoring of blood glucose as an adjunct to the care of persons with diabetes*
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.
Here's an analysis of the provided text, focusing on acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific numerical acceptance criteria for the GLUCOMETER ENCORE® Blood Glucose Test Strips. Instead, it describes a comparative study showing the device "compared well" and is "equivalent in performance" to predicate devices and other laboratory methods.
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance |
|---|---|
| Not explicitly stated | Compared well to predicate and other laboratory methods. |
| Not explicitly stated | Equivalent in performance to the predicate device. |
| Quantitative measurement range 10-600 mg/dL (0.6-33.3 mmol/L) | Device is capable of this range. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The text mentions "Fresh arterial specimens collected from catheters and deep sticks were used," implying multiple samples, but no specific number is provided.
- Data Provenance:
- Country of Origin: U.S. (from "STAT Laboratories of a large U.S. medical center").
- Retrospective or Prospective: Prospective, as it states "Fresh arterial specimens collected..."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is a quantitative measurement device for blood glucose. The "ground truth" is established by reference laboratory methods, not by human expert opinion or interpretation.
4. Adjudication Method for the Test Set
Not applicable, as the ground truth is established by reference laboratory methods rather than human interpretation requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC study was not done. This type of study is typically for image interpretation or diagnostic tasks where human readers are involved. This study compares a device's quantitative output to reference methods.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, this was a standalone performance study. The GLUCOMETER ENCORE systems (test strips with meters) were evaluated by themselves, with their results compared directly to other methods. There is no indication of a human-in-the-loop component for interpreting the device's output in the context of the performance assessment.
7. The Type of Ground Truth Used
The ground truth was established by "other laboratory methods for the determination of glucose" and comparison to the "Accu-Chek® Advantage™ H Blood Glucose Meter" (predicate device). This indicates that a gold standard or highly accurate laboratory reference method was used.
8. The Sample Size for the Training Set
Not applicable. The text describes a performance evaluation of a device, not a machine learning model that undergoes training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a machine learning model.
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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 70Elkhart, 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® BloodGlucose Test Strips (Modified)Test for glucose in bloodK96__________ |
| Classification: | Division of Clinical Laboratory DevicesPanel - Clinical Chemistry and ToxicologyClassification Code - 75 CFR (Hexokinase, Glucose) | |
| Predicate Devices: | GLUCOMETER ENCORE Blood Glucose Test StripsACCU-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 bypersons with diabetes and by healthcare professionals in homesettings and in healthcare facilities. GLUCOMETER ENCOREBlood Glucose Test Strips are for use with GLUCOMETERENCORE® Blood Glucose Meters. | |
| Intended Use: | GLUCOMETER ENCORE Blood Glucose Test Strips are for theself-monitoring of blood glucose as an adjunct to the care ofpersons 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.
§ 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.