K963676 · Medisense, Inc. · CGA · Feb 20, 1997 · Clinical Chemistry
Device Facts
Record ID
K963676
Device Name
PRECISION G BLOOD GLUCOSE TESTING SYSTEM
Applicant
Medisense, Inc.
Product Code
CGA · Clinical Chemistry
Decision Date
Feb 20, 1997
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 862.1345
Device Class
Class 2
Indications for Use
The Precision G Blood Glucose Testing System is intended for in vitro diagnostic use (i.e., for external use only) for the quantitative measurement of glucose in fresh whole blood. The Precision G Blood Glucose Testing System is intended for home or professional use. The product may also be used by healthcare professionals for quantitative measurement of glucose in venous or arterial whole blood, provided the sample is used within 15 minutes.
Device Story
Precision G Blood Glucose Testing System uses amperometric biosensor technology to measure glucose in whole blood or control solutions. User applies sample to test strip; glucose oxidase catalyzes oxidation of glucose to gluconic acid; electrochemical mediator transfers electrons to electrode surface; current generated is proportional to glucose concentration. System provides reading after 20-second countdown. Used in home or clinical settings by patients or healthcare professionals. Output allows monitoring of blood glucose levels for clinical decision-making.
Clinical Evidence
Clinical accuracy study compared lay users (n=200) and trained operators (n=200) against YSI reference analyzer. Results showed high correlation (r=0.982 for lay users, r=0.984 for trained operators) and mean absolute percent bias of 9.5% and 6.5% respectively. Study confirms equivalent performance between user groups.
Indicated for quantitative measurement of glucose in fresh whole blood for home or professional use; includes venous or arterial whole blood for healthcare professionals.
Regulatory Classification
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
Precision QID Blood Glucose Testing System (K944195)
Satellite G Blood Glucose Testing System (K896951)
Submission Summary (Full Text)
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K963676
# Summary of Safety and Effectiveness
**Submitted by:** Michael Halpin
Manager of Regulatory and Clinical Affairs
MediSense, Inc.
266 Second Avenue
Waltham MA 02154
**FEB 20 1997**
**Device Name:** Precision G Blood Glucose Testing System
**Common Name:** Blood Glucose Testing System
**Classification:** “Glucose Test System” - Class II per CFR 862.1345
**Predicate Devices:**
Precision QID Blood Glucose Testing System - K944195
Precision QID Blood Glucose Test Strip - K945887, K962295
Satellite G Blood Glucose Testing System - K896951
**Description:**
The Precision G Blood Glucose Testing System utilizes amperometric biosensor technology to quantitatively measure glucose in whole blood and control solutions. A drop of whole blood or control solution is applied to the target area of the test strip and the assay is automatically initiated. A countdown begins and glucose oxidase catalyzes the oxidation of glucose to produce gluconic acid. During the reaction, electrons are transferred by an electrochemical mediator to the electrode surface, generating a current that is measured by the Precision G Sensor. The size of the current is proportional to the amount of glucose present in the sample, thus giving an accurate reading of glucose concentration after 20 seconds.
The Precision G Blood Glucose Testing System was originally called the Satellite G System (K896951) but was renamed to the Precision G System in 1994.
**Intended Use:**
The Precision G Blood Glucose Testing System is intended for in vitro diagnostic use (i.e., for external use only) for the quantitative measurement of glucose in fresh whole blood. The Precision G Blood Glucose Testing System is intended for home or professional use. The product may also be used by healthcare professionals for quantitative measurement of glucose in venous or arterial whole blood, provided the sample is used within 15 minutes.
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Comparison to Predicate Device:
The proposed Precision G Blood Glucose Testing System has technological characteristics equivalent to those of the predicate Satellite G Blood Glucose Testing System (K896951). The proposed Precision G Testing System is also identical in intended use to another predicate device, the Precision QID Testing System (K944195, K945887, K962295). The intended use has been expanded to allow use of the system by home users in addition to use of the system by healthcare professionals.
Performance Studies:
Performance information on clinical accuracy of the Precision G Blood Glucose Testing System when used by lay users has been compared to clinical accuracy of the Precision G Blood Glucose Testing System when used by trained operators in the table below.
Accuracy Performance of the Precision G System for Trained Operators and Lay Users versus the YSI.
| | Combined Data Lay User vs. YSI Precision G Lots (170445, 171665) | Combined Data Trained Operator vs. YSI Precision G Lots (170445 and 171665) | Combined Data Trained Operator vs. Lay User Precision G Lots (170445, 171665) |
| --- | --- | --- | --- |
| Correlation Coefficient(s) | 0.982 | 0.984 | 0.981 |
| Slope | 0.966 | 0.933 | 1.018 |
| Y-Intercept | 13.5 mg/dL | 8.7 mg/dL | 7.3 mg/dL |
| Sy x | 13.9 mg/dL | 12.7 mg/dL | 14.4 mg/dL |
| N | 200 | 200 | 200 |
| Mean Absolute Percent Bias | 9.5% | 6.5% | 10.0% |
Conclusion:
The correlation coefficients and slopes obtained were close to 1.000 and y-intercepts close to $0\mathrm{mg / dL}$ indicating good correlation of the MediSense Precision G Blood Glucose Testing System to the reference analyzer when testing was conducted by trained operators and lay users. In addition, equivalent results were achieved by Lay Users and Trained Operators using the Precision G Blood Glucose Testing System.
