(404 days)
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No
The document describes a standard blood glucose monitoring system that measures glucose levels using test strips and a meter. There is no mention of AI, ML, or any advanced computational methods used for analysis or interpretation of the results beyond the direct measurement of glucose concentration.
No
The device is an In Vitro Diagnostic (IVD) device intended for measuring glucose levels, which is a diagnostic function, not a therapeutic one. It aids in monitoring the effectiveness of diabetes control but does not directly treat or prevent a disease.
Yes
Explanation: The device is intended for the "quantitative measurement of glucose" which aids in "monitoring the effectiveness of diabetes control." While it explicitly states it's "not for the diagnosis of, or screening for diabetes mellitus," the act of measuring a physiological parameter to monitor a condition falls under the umbrella of diagnostic devices, even if it's for management rather than initial diagnosis.
No
The device description explicitly states that the system consists of a "Blood Glucose Meter" and "Glucose Test Strips," which are hardware components. The 510(k) summary focuses on the performance of the entire system, including the meter and strips, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
The Intended Use / Indications for Use section explicitly states: "Testing is done outside the body (In Vitro diagnostic use)." This is a key characteristic of an IVD. The device is designed to measure glucose in blood samples taken from the body, which is performed in vitro (outside the living organism).
N/A
Intended Use / Indications for Use
The EG V1 Pro Self Monitoring Blood Glucose Test System is intended for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from fingertip. Testing is done outside the body (In Vitro diagnostic use). It is intended for multiple-patient use in professional healthcare settings, as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use lancing devices. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus.
The system consists of the EG V1 Pro meter and the EG Pro test strips. The EG V1 Pro meter only is used with the EG Pro test strips to quantitatively measure glucose in venous whole blood or fresh capillary whole blood from fingertip.
The EG Glucose Control Solution
For use with the EG V1 Pro Blood Glucose Self Monitoring System as a quality control check to verify the accuracy of blood glucose test results.
The EG V1 (BL) Self Monitoring Blood Glucose Test System is intended for the quantitative measurement of glucose in fresh capillary whole blood from fingertip, palm, or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can be only used during steady-state blood qlucose conditions.
The system consists of the EG V1 (BL) meter and the EG test strips. The EG V1 (BL) meter only is used with the EG V1 test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm.
The EG Glucose Control Solution
For use with EG V1(BL) Blood Glucose Self Monitoring System as a quality control check to verify the accuracy of blood glucose test results.
Product codes (comma separated list FDA assigned to the subject device)
NBW, LFR, JJX
Device Description
The EG V1 Pro Self-Monitoring Blood Glucose System consists of the EG V1 Pro Blood Glucose Meter, EG Pro Glucose Test Strips, single-use Lancing Device and EG Level 2 Control Solution. (Please refer to the IFU for the product picture)
The EG V1 (BL) Self-Monitoring Blood Glucose System consists of the EG V1 (BL) Blood Glucose Meter, EG Glucose Test Strips, Auto-Lancet Device and EG Level 2 Control Solution. (Please refer to the IFU for the product picture)
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
EG V1 Pro: venous whole blood or fresh capillary whole blood from fingertip.
EG V1 (BL): fresh capillary whole blood from fingertip, palm or forearm.
Indicated Patient Age Range
The system is not to be used on neonates.
Intended User / Care Setting
EG V1 Pro: It is intended for multiple-patient use in professional healthcare settings.
EG V1 (BL): It is indicated for use at home (over the counter [OTC]) by a single patient with diabetes and should not be shared.
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)
Analytical performance:
Precision/Reproducibility:
Within-run Precision – Venous blood was used and glucolyzed/spiked to prepare 6 different levels of glucose concentration (20-600 mg/dL). For each range, 10 meters, 10 test strips per meter, and 2 lots of test strips were used (N=10 Meters x10 tests x 2 lots = 200).
Results: Ranges showed CV (%) from 2.7% to 6.5%.
Day-to-Day Precision - 10 Meters, 2 lots of test strips, and 3 control solutions (Level 1, 2, and 3) were used. Each control was tested twice a day for 10 days (N=10 Meter x 2 Lots x 2 tests x10 days = 400).
Results: CV (%) ranged from 2.1% to 7.5%.
Linearity assay reportable range:
A 25 mL venous whole blood sample was treated with heparin. Blood was supplemented with ß-D-glucose to prepare seven different blood glucose levels (20-600 mg/dL). A total of 630 tests were performed to determine linear regression in three test strip lots. (N=3 tests/day x 10 days x 7 glucose ranges = 210 for each strip lot).
Results: Slope = 0.9809, Y-intercept = 0.8180, R2 = 0.9973.
Analytical specificity:
Hematocrit interference was evaluated by adjusting glucose and hematocrit levels (20%, 30%, 40%, 50%, and 60%) of venous blood samples from several donors. (N=2 times x 5 meters x 4 glucose ranges = 40 per hematocrit level). The acceptance criteria were bias ≤ 15 mg/dL when glucose concentration
§ 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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MAY 2 3 2011
510(k) SUMMARY for EG V1 Pro Self Monitoring Glucose Test System
A. Submitter's information
EPS Bio Technology Corp. Company: No. 8, R&D RD. III, Hsinchu Science Park Hsinchu City, Taiwan, R.O.C. Address: Mr. Y.C. Lei, General Manager Contact Name: 886-3-6686868 Phone: 886-3-6686866 Fax:
B. Measured:
Glucose
- C. Type of Test: Quantitative; electrochemical biosensor
- D. Proprietary and Established Names: EG V1 Pro Self-Monitoring Blood Glucose Test System
E. Common or Usual Name: Glucose Test System
F. Regulatory Information:
-
- Regulation section: 21 CFR 862.1345, Glucose Test System 21 CFR 862.1660, Quality control materials (assayed and unassayed)
-
- Classification: Class II Class I, reserved
3. Product code:
NBW, System Test, Blood Glucose, Over the Counter LFR, Glucose Dehydrogenase, Glucose JJX, Single (Specified) Controls (assayed and Unassayed)
-
- Panel: Chemistry 75
G. Intended Use:
-
- Intended use(s): See Indications for Use below
1
2. Indication(s) for use:
The EG V1 Pro Self Monitoring Blood Glucose Test System is intended for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from fingertip. Testing is done outside the body (In Vitro diagnostic use). It is intended for multiple-patient use in professional healthcare settings, as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use lancing devices. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus.
The system consists of the EG V1 Pro meter and the EG Pro test strips. The EG V1 Pro meter only is used with the EG Pro test strips to quantitatively measure glucose in venous whole blood or fresh capillary whole blood from fingertip.
The EG Glucose Control Solution
For use with the EG V1 Pro Blood Glucose Self Monitoring System as a quality control check to verify the accuracy of blood glucose test results.
H. Device Description:
The EG V1 Pro Self-Monitoring Blood Glucose System consists of the EG V1 Pro Blood Glucose Meter, EG Pro Glucose Test Strips, single-use Lancing Device and EG Level 2 Control Solution. (Please refer to the IFU for the product picture)
l. Substantial Equivalence Information:
-
- Predicate device name(s): ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; REAGENT STRIP, MODEL 7080
-
- Device Company BAYER HEALTHCARE
-
- Predicate 510(k) number(s): K062058
4. Comparison with predicate:
| Similarities | ||
|---|---|---|
| Item | Device | Predicate |
| Detection method | Amperometry | Amperometry |
| Enzyme | Glucose Dehydrogenase | |
| (FAD) | Glucose Dehydrogenase | |
| (FAD) | ||
| Sample volume | $\geq$ 0.6 uL | $\geq$ 0.6 uL |
| Temperature range | 10-40°C | 10-40°C |
| Memory capability | 480 tests with date and time | 480 tests with date and time |
| Hematocrit range | 20-60% | 20-60% |
| Power | 3V CR2032 batteries | 3V CR2032 batteries |
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| Differences | ||
|---|---|---|
| Item | Device | Predicate |
| Test range | 20-600 mg/dL | 10-600 mg/dL |
| Anatomical Sites | Venous sample and | |
| Capillary samples from the | ||
| fingertip, palm, forearm, | Capillary samples from the | |
| fingertip, palm, forearm, | ||
| abdomen and thigh | ||
| Test time | 5 seconds | 8 seconds |
| Size L x W x H (inch) | 3.5"x 2.1"x 0.97" | 2.8"x 2.35"x 0.77" |
| Weight | 2.05 oz (without batteries) | 2.0 oz (without batteries) |
J. Standard/Guidance Document Referenced (if applicable):
- ISO 15197:2003, In Vitro Diagnostic Test Systems Requirements for Blood 1. Glucose Monitoring Test Systems for Self Managing Diabetes Mellitus.
- ISO 14971:2007, Medical Devices Application of Risk Management to Medical 2. Devices.
- EN 13640:2002, Stability Testing of In Vitro Diagnostic Reagents. న.
- IEC 60601-1-2:2004. Medical electrical equipment Part 1: General requirement for 4. safety; Electromagnetic compatibility -Requirements and tests.
- IEC 61010-2-101:2002, Safety Requirements for Electrical Equipment for 5. Measurement, Control, and Laboratory Use - Part 2-101: Particular Requirements for In Vitro Diagnostic (IVD) Medical Equipment.
- IEC 60601-1:2005, Medical Electrical Equipment Part 1: General Requirements for ి. Safety.
- CLSI EP7-2A:2005, Interference Testing in Clinical Chemistry. 7.
K. Test Principle:
The EG V1 Pro Self-Monitoring Blood Glucose System employs a disposable dry reagent strip technology, using glucose dehydrogenase method to quantify glucose. Each test strip features an electrode containing the glucose dehydrogenase (in the presence of the coenzyme: Flavin Adenine Dinucleotide, FAD). A blood sample is applied to the blood collection area at the tip of the strip and is automatically drawn into the reaction zone, where the FAD-binding glucose dehydrogenase catalyzes glucose to dehydrogenate and to produce gluconolactone. During the reaction, a mediator transfers electrons to the electrode surface and generates a current. The amount of the current is proportional to the amount of glucose present in the blood sample. The glucose concentration is calculated in the EG V1 Pro Glucose Meter and displayed on the screen after 5 seconds.
L. Performance Characteristics (if/when applicable):
-
- Analytical performance:
- a. Precision/Reproducibility:
Within-run Precision – The testing was used by venous blood, which was stored in the heparin blood collection tube. Glucose was glucolyzed/spiked to the blood to prepare 6 different levels of glucose concentration: 20-50 mg/dL, 51-110 mg/dL, 111-150 mg/dL, 151-250 mg/dL, 251-400 mg/dL, and 401~600 mg/dL. For each testing range, 10 meters, 10 pcs of test strips for each meter, and 2 lots of test strips were used. (N=10 Meters x10 tests x 2 lots =200)
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| EG V1 SMBG system | ||||
|---|---|---|---|---|
| Range (mg/dL) | N | Mean | ||
| (mg/dL) | SD | |||
| (mg/dL) | CV (%) | |||
| 20~50 mg/dL | 200 | 40.7 | 2.6 | 6.5% |
| 51~110 mg/dL | 200 | 108.5 | 3.5 | 3.2% |
| 111~150 mg/dL | 200 | 137.0 | 4.5 | 3.3% |
| 151~250 mg/dL | 200 | 223.5 | 6.4 | 2.9% |
| 251~400 mg/dL | 200 | 399.8 | 11.0 | 2.8% |
| 401~600 mg/dL | 200 | 512.1 | 13.9 | 2.7% |
| Level 2 control solution | 200 | 118.2 | 3.3 | 2.8% |
Day-to-Day Precision - 10 Meters, 2 lots of test strips, and 3 control solutions (Level 1, 2, and 3) were prepared. Each control was tested twice a day, once in the morning and once in the afternoon consecutively for 10 days.
(N=10 Meter x 2 Lots x 2 tests x10 days =400)
| Control
solution | N | mean
(mg/dL) | SD
(mg/dL) | CV (%) |
|---------------------|-----|-----------------|---------------|--------|
| Level 1 | 400 | 41.8 | 3.1 | 7.5% |
| Level 2 | 400 | 120.7 | 3.1 | 2.6% |
| Level 3 | 400 | 349.8 | 7.2 | 2.1% |
- b. Linearity assay reportable range:
A 25 mL venous whole blood sample was treated with heparin vacuum tube. The blood supplemented with ß -D-glucose to prepare seven different blood glucose levels (20-50 mg/dL, 51-80 mg/dL, 81-120 mg/dL, 121-200 mg/dL, 201-300 mg/dL, 301-400 mg/dL, and 400-600 mg/dL). A total of 630 tests were performed to determine the linear regression in three test strip lots.
For each strip lot, N=3 tests/day x 10 days x 7 glucose ranges=210
The linear regression was as follows:
| N= | 630 (210X3Lot) |
|---|---|
| Slope | 0.9809 |
| Y-intercept | 0.8180 |
| R2 | 0.9973 |
- Traceability, Stability, Expected values (controls, calibrators, or methods): ﻥ The device was traceable to a laboratory YSI 2300D analyzer. The YSI 2300D analyzer was calibrated before use and the calibrator was manufactured gravimetrically and provided from the instrument supplier. The YSI 2300D analyzer is validated by using the international standard reference material (NIST 965b) every year.
Stability characteristics of the level 2 and level 3 control solutions were determined by performing real-time stability studies and the shelf life could be up to 19 months
4
at the room temperature.
-
d. Detection limit:
Data was provided to support a reportable range of 20-600 mg/dL. -
e. Analytical specificity:
Hematocrit interference was evaluated by adjusting the glucose and hematocrit levels of venous blood samples from several donors. The venous blood samples were glucolyzed/spiked to 4 glucose concentrations and the hematocrit levels were adjusted to 20%, 30%, 40%, 50% and 60%. For each hematocrit level, the linear regression was determined by 40 testing results, N=2 times x 5 meters x 4 glucose ranges=40. The maximum percent bias was calculated by comparing to the YSI reading and shown on each linear regression. The acceptance criteria of Hematocrit interference test is: bias ≤15 mg/dL when glucose concentration 0.6 uL | > 0.6 uL |
| Temperature range | 10-40°C | 10-40°C |
| Memory capability | 480 tests with date and
time | 480 tests with date and
time |
| Hematocrit range | 20-60% | 20-60% |
| Power | 3V CR2032 batteries | 3V CR2032 batteries |
| Differences | ||
|---|---|---|
| Item | Device | Predicate |
| Test range | 20-600 mg/dL | 10-600 mg/dL |
| Anatomical Sites | Venous sample and | |
| Capillary samples from the | ||
| fingertip, palm, forearm, | Capillary samples from the | |
| fingertip, palm, forearm, | ||
| abdomen and thigh | ||
| Test time | 5 seconds | 8 seconds |
| Size L x W x H (inch) | 3.5"x 2.1"x 0.97" | 2.8"x 2.35"x 0.77" |
| Weight | 2.05 oz (without batteries) | 2.0 oz (without batteries) |
J. Standard/Guidance Document Referenced (if applicable):
- ISO 15197:2003, In Vitro Diagnostic Test Systems Requirements for Blood 1. Glucose Monitoring Test Systems for Self Managing Diabetes Mellitus.
- ISO 14971:2007, Medical Devices Application of Risk Management to Medical 2. Devices.
- EN 13640:2002, Stability Testing of In Vitro Diagnostic Reagents. 3.
- IEC 60601-1-2:2004. Medical electrical equipment Part 1: General requirement for 4. safety: Electromagnetic compatibility -Requirements and tests.
- IEC 61010-2-101:2002, Safety Requirements for Electrical Equipment for 5. Measurement, Control, and Laboratory Use - Part 2-101: Particular Requirements for In Vitro Diagnostic (IVD) Medical Equipment.
- IEC 60601-1:2005, Medical Electrical Equipment Part 1: General Requirements for 6. Safety.
- CLSI EP7-2A:2005, Interference Testing in Clinical Chemistry. 7.
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K. Test Principle:
The EG V1 (BL) Self-Monitoring Blood Glucose System employs a disposable dry reagent strip technology, using glucose dehydrogenase method to quantify glucose. Each test strip features an electrode containing the glucose dehydrogenase (in the presence of the coenzyme: Flavin Adenine Dinucleotide, FAD). A blood sample is applied to the blood collection area at the tip of the strip and is automatically drawn into the reaction zone, where the FAD-binding glucose dehydrogenase catalyzes glucose to dehydrogenate and to produce qluconolactone. During the reaction, a mediator transfers electrons to the electrode surface and generates a current. The amount of the current is proportional to the amount of glucose present in the blood sample. The glucose concentration is calculated in the EG V1 (BL) Glucose Meter and displayed on the screen after 5 seconds.
L. Performance Characteristics (if/when applicable):
-
- Analytical performance:
- a. Precision/Reproducibility:
Within-run Precision – The testing was used by venous blood, which was stored in the heparin blood collection tube. Glucose was glucolyzed/spiked to the blood to prepare 6 different levels of glucose concentration: 20-50 mg/dL, 51-110 mg/dL, 111-150 mg/dL, 151-250 mg/dL, 251-400 mg/dL, and 401~600 mg/dL. For each testing range, 10 meters, 10 pcs of test strips for each meter, and 2 lots of test strips were used. (N=10 Meters x10 tests x 2 lots =200)
| EG V1 SMBG system | ||||
|---|---|---|---|---|
| Range (mg/dL) | N | Mean | ||
| (mg/dL) | SD | |||
| (mg/dL) | CV (%) | |||
| 20~50 mg/dL | 200 | 40.7 | 2.6 | 6.5% |
| 51~110 mg/dL | 200 | 108.5 | 3.5 | 3.2% |
| 111~150 mg/dL | 200 | 137.0 | 4.5 | 3.3% |
| 151~250 mg/dL | 200 | 223.5 | 6.4 | 2.9% |
| 251~400 mg/dL | 200 | 399.8 | 11.0 | 2.8% |
| 401~600 mg/dL | 200 | 512.1 | 13.9 | 2.7% |
| Level 2 control solution | 200 | 118.2 | 3.3 | 2.8% |
Dav-to-Day Precision - 10 Meters, 2 lots of test strips, and 3 control solutions (Level 1, 2, and 3) were prepared. Each control was tested twice a day, once in the morning and once in the afternoon consecutively for 10 days.
(N=10 Meter x 2 Lots x 2 tests x10 days =400) .
| Control
solution | N | mean
(mg/dL) | SD
(mg/dL) | CV (%) |
|---------------------|-----|-----------------|---------------|--------|
| Level 1 | 400 | 41.8 | 3.1 | 7.5% |
| Level 2 | 400 | 120.7 | 3.1 | 2.6% |
| Level 3 | 400 | 349.8 | 7.2 | 2.1% |
- b. Linearity assay reportable range:
A 25 mL venous whole blood sample was treated with heparin vacuum tube. The
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blood supplemented with { -D-glucose to prepare seven different blood glucose levels (20-50 mg/dL, 51-80 mg/dL, 81-120 mg/dL, 121-200 mg/dL, 201-300 mg/dL, 301-400 mg/dL, and 400-600 mg/dL). A total of 630 tests were performed to determine the linear regression in three test strip lots.
For each strip lot, N=3 tests/day x 10 days x 7 glucose ranges=210
The linear regression was as follows:
| N= | 630 (210X3Lot) |
|---|---|
| Slope | 0.9809 |
| Y-intercept | 0.8180 |
| R2 | 0.9973 |
-
c. Traceability, Stability, Expected values (controls, calibrators, or methods): The device was traceable to a laboratory YSI 2300D analyzer. The YSI 2300D analyzer was calibrated before use and the calibrator was manufactured gravimetrically and provided from the instrument supplier. The YSI 2300D analyzer is validated by using the international standard reference material (NIST 965b) every year.
Stability characteristics of the Level 2 and Level 3 control solutions were determined by performing real-time stability studies and the shelf life could be up to 19 months at the room temperature. -
d. Detection limit:
Data was provided to support a reportable range of 20-600 mg/dL. -
e. Analytical specificity:
Hematocrit interference was evaluated by adjusting the glucose and hematocrit levels of venous blood samples from several donors. The venous blood samples were glucolyzed/spiked to 4 glucose concentrations and the hematocrit levels were adjusted to 20%, 30%, 40%, 50% and 60%. For each hematocrit level, the linear regression was determined by 40 testing results, N=2 times x 5 meters x 4 glucose ranges=40. The maximum percent bias was calculated by comparing to the YSI reading and shown on each linear regression. The acceptance criteria of Hematocrit interference test is: bias ≤ 15 mg/dL when glucose concentration