(160 days)
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No
The device description details a standard electrochemical biosensor technology for glucose measurement, with no mention of AI or ML algorithms for data processing or interpretation.
No.
The device is for measuring glucose levels, which is a diagnostic function, not a therapeutic one (treatment or prevention of a disease).
Yes
The 'Intended Use / Indications for Use' section explicitly states that the system "is intended for in vitro diagnostic use".
No
The device description explicitly details hardware components (test strip, sensor) and a physical process (applying blood, electrochemical reaction) for measuring glucose. It is a system that includes hardware.
Yes, the provided text explicitly states that the device is an IVD.
Here's the relevant sentence from the "Intended Use / Indications for Use" section:
"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."
N/A
Intended Use / 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.
Product codes
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Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
home or professional use. The product may also be used by healthcare professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Accuracy Performance of the Precision G System for Trained Operators and Lay Users versus the YSI.
Sample Size (N): 200 for each comparison (Lay User vs. YSI, Trained Operator vs. YSI, Trained Operator vs. Lay User)
Key Results:
- Lay User vs. YSI: Correlation Coefficient = 0.982, Slope = 0.966, Y-Intercept = 13.5 mg/dL, Syx = 13.9 mg/dL, Mean Absolute Percent Bias = 9.5%
- Trained Operator vs. YSI: Correlation Coefficient = 0.984, Slope = 0.933, Y-Intercept = 8.7 mg/dL, Syx = 12.7 mg/dL, Mean Absolute Percent Bias = 6.5%
- Trained Operator vs. Lay User: Correlation Coefficient = 0.981, Slope = 1.018, Y-Intercept = 7.3 mg/dL, Syx = 14.4 mg/dL, Mean Absolute Percent Bias = 10.0%
Conclusion: The correlation coefficients and slopes obtained were close to 1.000 and y-intercepts close to 0 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.
Key Metrics
Correlation Coefficient, Slope, Y-Intercept, Syx, Mean Absolute Percent Bias
Predicate Device(s)
Precision QID Blood Glucose Testing System - K944195, Precision QID Blood Glucose Test Strip - K945887, K962295, Satellite G Blood Glucose Testing System - K896951
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Summary of Safety and Effectiveness
人 - 上一篇:
| 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. | |
| 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 | |
il
1
Accuracy Performance of the Precision G System for Trained Operators and Lay Users versus the YSI.
when used by trained operators in the table below.
| | 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 |
| Syx | 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 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.