(74 days)
Not Found
No
The device description focuses on electrochemical principles and does not mention any AI/ML components or algorithms. The performance studies describe standard comparative testing, not AI/ML model validation.
No
The device is an in vitro diagnostic device used for measurement of glucose, not for treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for in vitro diagnostic use".
No
The device description explicitly details hardware components like a sensor, test strip, and the measurement of electrical current, indicating it is a physical device with integrated software, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The ExacTech RSG 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 capillary whole blood."
N/A
Intended Use / Indications for Use
The ExacTech RSG 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 capillary whole blood. The product is designed for home or professional use.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The ExacTech RSG Blood Glucose Testing System utilizes amperometric biosensor technology to quantitatively measure glucose in whole blood and control solutions. After inserting a test strip into the sensor, a drop of whole blood or control solution is applied to the target area of the test strip and the sensor button is pressed. 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 ExacTech RSG 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 30 seconds.
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
9 to 88 years
Intended User / Care Setting
Home or professional use.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparative nonclinical testing of the ExacTech RSG Blood Glucose Testing System and the standard ExacTech Blood Glucose Testing System included linearity and dynamic range testing. The performance of the ExacTech RSG System was determined to be comparable to the performance of the standard ExacTech System.
Comparative clinical testing of the ExacTech RSG Blood Glucose Testing System and the standard ExacTech Blood Glucose Testing System was performed at three sites and included a clinic, physician's office, and clinical research center. A total of 178 subjects (34% male, 66% female) ranging in age from 9 to 88 years participated in the study. The majority of participants were either White or Hispanic. A diversity of both education and occupation was observed at all sites. Two of the sites had a higher percentage of subjects with NIDDM and one site had a higher percentage of subjects with IDDM.
To evaluate accuracy, capillary whole blood was collected from each subject and tested by a trained operator on both the new ExacTech RSG and standard ExacTech Systems, as well as a YSI Analyzer. Results for the three sites are summarized below and indicate that the accuracy of the ExacTech RSG System is comparable to the accuracy of the standard ExacTech System.
Correlation Coefficient (r): ExacTech RSG System 0.979, Standard ExacTech System 0.983
Slope (m), mg/dL: ExacTech RSG System 0.971, Standard ExacTech System 0.925
Y-intercept, mg/dL: ExacTech RSG System 2.2, Standard ExacTech System 4.7
N: ExacTech RSG System 288, Standard ExacTech System 170
To evaluate precision, venous whole blood was tested twenty times on both the new ExacTech RSG and standard ExacTech Systems. Results obtained at one of the sites are summarized below and indicate that the precision of the ExacTech RSG System is comparable to the precision of the standard ExacTech System.
ExacTech RSG System: Mean 59.1 mg/dL, SD 3.03 mg/dL, CV 5.1%; Mean 89.2 mg/dL, SD 3.59 mg/dL, CV 4.0%; Mean 175.6 mg/dL, SD 7.37 mg/dL, CV 4.2%; Mean 297.5 mg/dL, SD 8.57 mg/dL, CV 2.9%
Standard ExacTech System: Mean 53.1 mg/dL, SD 3.77 mg/dL, CV 7.1%; Mean 87.9 mg/dL, SD 5.07 mg/dL, CV 5.8%; Mean 143.8 mg/dL, SD 9.77 mg/dL, CV 6.8%; Mean 268.0 mg/dL, SD 9.36 mg/dL, CV 3.5%
Conclusion:
Results of comparative nonclinical and clinical testing demonstrate that the performance of the ExacTech RSG Blood Glucose Testing System is comparable to the performance of the standard ExacTech Blood Glucose Testing System and suitable for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Correlation Coefficient (r), Slope (m, mg/dL), Y-intercept, N, Mean (mg/dL), SD (mg/dL), CV (%)
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.
ExacTech Blood Glucose Testing System - K863468
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image shows the word "MEDISENSE" in bold, black letters. To the left of the word is a black graphic that looks like three stacked, tilted rectangles. A circled R symbol is located to the right of the word.
ﺮﺳﻪ
ﻟﻤﺴﺴﺴﺎ
JIN 21 189
MediSense, Inc.
266 Second Avenue
Waltham, MA 02154
Telephone: 617.895.6000
Fax: 617.890.1711
510(k) Summary
| Submitter/
Contact Person: | Michael Halpin, Manager Regulatory and Clinical Affairs
MediSense, Inc.
266 Second Avenue
Waltham, MA 02154
Telephone: #617-895-6289
Fax: #617-890-1711 |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | April 18, 1996 |
| Device Name: | ExacTech RSG Blood Glucose Testing System |
| Common Name: | Blood Glucose Test System |
| Classification: | "Glucose Test System" - Class II per CFR 862.1345 |
| Predicate Devices: | ExacTech Blood Glucose Testing System - K863468 |
| Description: | The ExacTech RSG Blood Glucose Testing System utilizes amperometric
biosensor technology to quantitatively measure glucose in whole blood and
control solutions. After inserting a test strip into the sensor, a drop of whole
blood or control solution is applied to the target area of the test strip and the
sensor button is pressed. 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 ExacTech RSG 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 30
seconds. |
| Intended Use: | The ExacTech RSG 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 capillary whole blood. The product is designed for home or
professional use. |
| Comparison to
Predicate Device: | The ExacTech RSG Blood Glucose Testing System has technological
characteristics equivalent to those of the predicate ExacTech Blood Glucose
Testing System.
The hardware for the ExacTech RSG Sensor has been revised compared to the
predicate ExacTech Sensor to improve user features such as ease of test strip
insertion, ease of test initiation and display readability. The software for the
ExacTech RSG Sensor has been revised compared to the predicate ExacTech
software to include pre-programmed universal calibration information
eliminating the need for a calibration procedure. |
.
1
The only design difference between the new ExacTech RSG test strips and the predicate ExacTech test strips is the method of calibration. ExacTech RSG test strips do not require a user calibration procedure because the sensor is preprogrammed with universal calibration information specific to ExacTech RSG test strips.
Performance Studies:
Comparative nonclinical testing of the ExacTech RSG Blood Glucose Testing System and the standard ExacTech Blood Glucose Testing System included linearity and dynamic range testing. The performance of the ExacTech RSG System was determined to be comparable to the performance of the standard ExacTech System.
Comparative clinical testing of the ExacTech RSG Blood Glucose Testing System and the standard ExacTech Blood Glucose Testing System was performed at three sites and included a clinic, physician's office, and clinical research center. A total of 178 subjects (34% male, 66% female) ranging in age from 9 to 88 years participated in the study. The majority of participants were either White or Hispanic. A diversity of both education and occupation was observed at all sites. Two of the sites had a higher percentage of subjects with NIDDM and one site had a higher percentage of subjects with IDDM.
To evaluate accuracy, capillary whole blood was collected from each subject and tested by a trained operator on both the new ExacTech RSG and standard ExacTech Systems, as well as a YSI Analyzer. Results for the three sites are summarized below and indicate that the accuracy of the ExacTech RSG System is comparable to the accuracy of the standard ExacTech System.
| | ExacTech RSG
System | Standard ExacTech
System |
|-----------------------------|------------------------|-----------------------------|
| Correlation Coefficient (r) | 0.979 | 0.983 |
| Slope (m), mg/dL | 0.971 | 0.925 |
| Y-intercept, mg/dL | 2.2 | 4.7 |
| N | 288 | 170 |
To evaluate precision, venous whole blood was tested twenty times on both the new ExacTech RSG and standard ExacTech Systems. Results obtained at one of the sites are summarized below and indicate that the precision of the ExacTech RSG System is comparable to the precision of the standard ExacTech System.
| ExacTech RSG System | Standard ExacTech System | ||||
|---|---|---|---|---|---|
| Mean, | |||||
| mg/dL | SD, | ||||
| mg/dL | CV, | ||||
| % | Mean, | ||||
| mg/dL | SD, | ||||
| mg/dL | CV, | ||||
| % | |||||
| 59.1 | 3.03 | 5.1 | 53.1 | 3.77 | 7.1 |
| 89.2 | 3.59 | 4.0 | 87.9 | 5.07 | 5.8 |
| 175.6 | 7.37 | 4.2 | 143.8 | 9.77 | 6.8 |
| 297.5 | 8.57 | 2.9 | 268.0 | 9.36 | 3.5 |
Conclusion:
Results of comparative nonclinical and clinical testing demonstrate that the performance of the ExacTech RSG Blood Glucose Testing System is comparable to the performance of the standard ExacTech Blood Glucose Testing System and suitable for its intended use.