(157 days)
K 971812
Not Found
No
The summary describes a standard blood glucose monitoring system and does not mention any AI or ML components or capabilities.
No
The device is solely for measuring glucose levels and monitoring diabetes management, not for treating or providing therapy.
Yes
The device measures glucose levels in blood, which aids in monitoring the effectiveness of diabetes management. This falls under the definition of a diagnostic device as it provides information used to identify or monitor a medical condition.
No
The device description explicitly lists hardware components such as a meter, test strips, lancet device, check strip, code card, and control solution.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative measurement of glucose levels in fresh capillary whole blood." This is a measurement performed in vitro (outside the body) on a biological sample.
- Device Description: The system includes components like test strips and control solution, which are typical for IVD devices used for chemical analysis of biological samples.
- Anatomical Site: The sample is "fresh capillary whole blood," which is a biological specimen.
- Performance Studies: The performance studies describe analytical performance testing (precision, linearity, specificity) and comparison studies with a reference method (YSI 2300 Analyzer) using blood samples. These are standard types of studies for validating the performance of IVD devices.
- Predicate Device: The mention of a predicate device (Precision® QID Blood Glucose Testing System) with a K number (K 971812) further indicates that this device is being compared to a previously cleared IVD.
All these factors strongly point to the Easy Pain Supreme Self-Monitoring Blood Glucose System being an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Easy Pain Supreme Self-Monitoring Blood Glucose System is used by individuals with diabetes. It is for the quantitative measurement of glucose levels in fresh capillary whole blood, as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings. Special condition for use statement(s) : Provides plasma equivalent results. Special instrument Requirements : N/A
Product codes (comma separated list FDA assigned to the subject device)
NBW, CGA, JJX
Device Description
The Easy Pain Supreme Self-Monitoring Blood Glucose System consists of the Easy Pain Supreme meter, Easy Pain Supreme Glucose Test Strips, Auto-Lancet Device, Check Strip, Code Card, and Control Solution.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Used by individuals with diabetes, in the home and in clinical settings.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
1. Analytical performance:
Precision / Reproducibility:
Testing was conducted by taking 4 mL of blood that was treated with Heparin through a vacuum tube. Glucose was added to the 4 mL of blood to generate 5 different levels of glucose concentration for the test. Each of the samples was measured 5 times. (See Table I for Summary of Test Results)
Table I : Summary of Test Results:
Level 1: 200 assays, Mean 43 mg/dL, SD 2.4 mg/dL, CV 4.3%
Level 2: 200 assays, Mean 95 mg/dL, SD 5.3 mg/dL, CV 3.5%
Level 3: 200 assays, Mean 144 mg/dL, SD 8.0 mg/dL, CV 3.3%
Level 4: 200 assays, Mean 246 mg/dL, SD 13.7 mg/dL, CV 3.1%
Level 5: 200 assays, Mean 398 mg/dL, SD 22.1 mg/dL, CV 3.3%
Within-Run Precision / Day-to-Day Precision:
Three control solutions of Low, Normal and High were prepared. Each of the controls was measured twice a day, once in the morning and once in the afternoon for a month.
Low: 400 assays, Mean 56 mg/dL, SD 3.10 mg/dL, CV 5.6%
Normal: 400 assays, Mean 129 mg/dL, SD 4.49 mg/dL, CV 3.5%
High: 400 assays, Mean 388 mg/dL, SD 10.21 mg/dL, CV 2.6%
a. Linearity / assay reportable range:
A blood sample of 25 mL was taken, treated with Heparin vacuum tube, to be set for a day. Testing was performed using whole blood tube to provide samples at seven different supplemented within a total of 210 tests were preformed using 5 meters among the seven glucose ranges per each strip lot. The meters among the seven ranges demonstrated the following regression:
Y=0.9589x + 6.1617
R2=0.9958; Syx=10.14; N=630
Range: 40-600 mg/dL (2.2-33.3 mmol/L)
b. Traceability (controls, calibrators, or method):
CAS# Glucose #492615 SigmaUltra MFCD00063989. Traceability referenced to NBS, NIST Standards.
c. Detection limit:
40-600 mq/dL 2.2-33.3 mmol/L
d. Analytical Specifiecity:
Interference testing was conducted to determine the effect of selected endogenous and exogenous substances. A series of test samples, systematically varying in the concentration of the interferents, was prepared by making quantitative, volumetric mixtures of two pools: one at the highest concentration to be tested and the other at the lowest. Substances and concentrations of the interferents are recommended at NCCLS EP7-P.
e. Assay cut-off: N/A
2. Comparison studies:
a. Method comparison with predicate device:
The accuracy of the Easy Pain Supreme Self-Monitoring Blood Glucose System was assessed by comparing blood glucose results obtained using the YSI 2300 Analyzer. The results below were obtained by 202 subjects with diabetes. Regression statistics are derived from a three point-calibration capillary data versus YSI plasma data.
The Linear regression of the 202 diabetic patients - YSI 2300 vs. easy Pain Supreme System presented the following regression:
Slope= 0.967
y-intercept = 11.98 mg/dL
Correlation coefficient(r) = 0.972
No. of samples = 202
Range tested = 33-514 mg/dL
Matrix comparison: N/A
b. Matrix comparison: N/A
3. Clinical studies:
a. Clinical sensitivity: N/A
b. Clinical specificity: N/A
c. Other clinical supportive data (when a and b are not applicable): See Attachment 12
- N/A 4. Clinical cut-off : N/A
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K 971812
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.
Not Found
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
510(K) SUMMARY
APR 2 9 2005
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92
| 1.0 Submitter's Name: | EPS Bio Technology Corp. |
|---|---|
| Address: | 2F, No.49-2, Lane 2, Guang Fu Rd., Sec. 2, Hsinchu City , |
| Taiwan, R.O.C. | |
| Phone: | 886-3-5752522 |
| Fax: | 886-3-5752552 |
| Contact: | Mr. Y.C. Lei, General Manager |
| 2.0 Device Name: | A. Easy Pain Supreme Self-Monitoring Blood Glucose System |
| 3.0 Classification: | Class II |
| 4.0 Predicate Device: | The predicate device is the Precision® QID Blood Glucose Testing |
| System (K 971812) marketed by Medisense Inc. | |
| 5.0 Device Description: | The Easy Pain Supreme Self-Monitoring Blood Glucose System |
| consists of the Easy Pain Supreme meter, Easy Pain Supreme | |
| Glucose Test Strips, Auto-Lancet Device, Check Strip, Code Card, | |
| and Control Solution. | |
| 6.0 Indication for Use: | The Easy Pain Supreme Self-Monitoring Blood Glucose System is |
| used by individuals with diabetes. It is for the quantitative | |
| measurement of glucose levels in fresh capillary whole blood, as | |
| an aid in monitoring the effectiveness of diabetes management in | |
| the home and in clinical settings. | |
| Special condition for use statement(s) : | |
| Provides plasma equivalent results. | |
| Special instrument Requirements : N/A |
1
7.0 Comparison with predicate :
| Similarities | ||
|---|---|---|
| Item | Device | Predicated |
| Easy Pain Supreme | Precision QID | |
| Detection method | Amperometry : current is | |
| generated by oxidation of | ||
| reduced mediator. | Amperometry | |
| Enzyme | Glucose Oxidase | |
| (Aspergillus niger) | Glucose Oxidase | |
| (Aspergillus niger) | ||
| Mediator | Potassium ferricyanide | Potassium ferricyanide |
| Electrode | Carbon electrode | Carbon electrode |
| Differences | ||
|---|---|---|
| Item | Device | Predicated |
| Easy Pain Supreme | Precision QID | |
| Test range | 40-600 mg/dL | 20-600 mg/dL |
| Hematocrit Range | 30-55% | 20-70% |
| Test Time | 25 seconds | 20 seconds |
| Sample Volume | ≥2.0uL | ≥3.5uL |
| Operating Range | ||
| Temperature | 10-40°C | 18-30°C |
| Humidity range | R.H.≤90% | R.H. : 10% to 90% |
| Open use time | 3 months | 3 months |
| Coding | Code Card | Calibrator |
| Memory | 100 blood glucose tests with | NA |
| Capability | Date and time | |
| Power | 1.5V (AAA)*2 batteries | Non-replaceable cell 3.0 V/DC |
| Battery life | Approximately 1,000 glucose tests | Approximately 4,000 glucose tests |
| Size : L x W x H (cm) | 7.5 x 5.4 x 1.9 | 9.7 x 4.80 x 1.45 |
| Weight | 50g (without batteries) | 39.35gram |
The Easy Pain Supreme Self-Monitoring Blood Glucose System employs 8.0 Test Principle a disposable dry reagent strip technology, based on the glucose oxidase method for glucose determination. Each test strip features an electrode containing the enzyme glucose oxidase (Aspergillus niger). 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 glucose oxidase catalyzes the oxidation of glucose to produce gluconic acid. 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 measured by the Easy Pain Supreme Glucose Meter and displayed on the screen after 25 seconds.
FDA 510(K) SUMMARY
2
9.0 Performance Characteristics
1. Analytical performance :
Precision / Reproducibility :
Testing was conducted by taking 4 mL of blood that was treated with Heparin through a vacuum tube. Glucose was added to the 4 mL of blood to generate 5 different levels of glucose concentration for the test. Each of the samples was measured 5 times. Below are the glucose concentration ranges for each level that were measured. (See Table I for Summary of Test Results)
| Level | Glucose Concentration Range |
|---|---|
| 1 | 40-50 mg/dL |
| 2 | 51-110 mg/dL |
| 3 | 111-150 mg/dL |
| 4 | 151-250 mg/dL |
| 5 | 251-400 mg/dL |
Three control solutions of Low, Normal and High were prepared. Each of the controls was measured twice a day, once in the morning and once in the afternoon for a month. (Table I (below) shows a summary of the Within-Run Precision and the Day-to-Day Precision Tests.)
Table I : Summary of Test Results
| Control
Samples | No. Of Assay | Mean
(mg/dL) | SD(mg/dL) | CV(%) |
|--------------------|--------------|-----------------|-----------|-------|
| Level 1 | 200 | 43 | 2.4 | 4.3 |
| Level 2 | 200 | 95 | 5.3 | 3.5 |
| Level 3 | 200 | 144 | 8.0 | 3.3 |
| Level 4 | 200 | 246 | 13.7 | 3.1 |
| Level 5 | 200 | 398 | 22.1 | 3.3 |
Within-Run Precision
| Day-to-Day Precision | ||
|---|---|---|
| Control
Samples | No. Of Assay | Mean
(mg/dL) | SD(mg/dL) | CV(%) |
|--------------------|--------------|-----------------|-----------|-------|
| Low | 400 | 56 | 3.10 | 5.6 |
| Normal | 400 | 129 | 4.49 | 3.5 |
| High | 400 | 388 | 10.21 | 2.6 |
3
9.0 Performance Characteristics(Cont.)
a. Linearity / assay reportable range :
- A blood sample of 25 mL was taken, treated with Heparin vacuum tube, to be set for a day, Testing was performed using whole blood tube, to be set for a Gay, 188.ing to provide samples at seven different supplemented within a total of 210 tests were preformed using 5 meters among the seven glucose ranges per each strip lot. The melers among the coven gide demonstrated the following regression
| mmol/L | mg/dL |
|---|---|
| 2.2- 2.8 | 40- 50 |
| 2.8-4.3 | 51-80 |
| 4.4-6.7 | 81-120 |
| 6.7-11.1 | 121-200 |
| 11.2-16.6 | 201-300 |
| 16.7-22.2 | 301-400 |
| 22.3-33.3 | 400-600 |
Y=0.9589x + 6.1617
R2=0.9958; Syx=10.14; N=630
- b. Traceability (controls, calibrators, or method) : CAS# (Chemical Abstract Service) MDL# (MDL, inc. formerly Molecular Design Laboratories) Glucose #492615 SigmaUltra MFCD00063989 Traceability referenced to NBS, NIST Standards
- c. Detection limit : 40-600 mq/dL 2.2-33.3 mmol/L
- d. Analytical Specifiecity :
Interference testing was conducted to determine the effect of select intonoronoo could exogenous substances. A series of test samples, systematically varying in the concentration of the interferents, was prepared by making quantitative, volumetric mixtures of two pools : one at the highest concentration to be tested and the other at the lowest. at the substances and concentrations of the interferents are recommended at NCCLS EP7-P.
- e. Assay cut-off : N/A
4
2. Comparison studies :
a. Method comparison with predicate device :
The accuracy of the Easy Pain Supreme Self-Monitoring Blood The accuracy of the Easy Part by comparing blood glucose results. Glucose System was accosse obtained using the YSI 2300 Analyzer. The results below were obtained by 202 subjects with diabetes at The results below were obtained by ssion statistics are derived from a three intoporis capillary data versus YSI plasma data.
The Linear regression of the 202 diabetic patients - YSI 2300 vs. easy Pain Supreme System presented the following regression :
| Slope= | 0.967 |
|---|---|
| y-intercept | 11.98 mg/dL |
| Correlation coefficient(r) | 0.972 |
| No. of samples | 202 |
| Range tested | 33-514 mg/dL |
| Matrix comparison: | N/A |
b. Matrix compariso
3. Clinical studies :
- a_Clinical sensitivity : N/A
- b. Clinical specificity : N/A
- c. Other clinical supportive data (when a and b are not applicable) : See Attachment 12
- N/A 4. Clinical cut-off :
5. Expected Values/Reference range :
Expected blood glucose levels for people without diabetes :
| Time | Range (mg/dL) | Range (mmol/L) |
|---|---|---|
| Before Breakfast : | 70 - 105 | 3.9 - 5.8 |
| Before Lunch or | ||
| Dinner : | 70 - 110 | 3.9 - 6.1 |
| 1 hour after meals : | Less than 160 | Less than 8.9 |
| 2 hour after meals : | Less than 120 | Less than 6.7 |
| Between 2 and 4 AM | Greater than 70 | Greater than 3. |
Where the above Expected Values is referenced from Joslin Diabetes Manual
5
8. Conclusions:
The Easy Pain Supreme Self-Monitoring Blood Glucose System have the same intended use and similar technological characteristics as Precision ® QID Blood Glucose Testing System (K 971812) marketed by Medisense Inc.. Moreover, bench testing contained in this submission and clinical testing supplied demonstrate that any differences in their technological characteristics do not raise and new questions of safety or effectiveness. Thus, the Easy Pain Supreme Self-Monitoring Blood Glucose System is substantially equivalent to the predicate devices.
6
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three flowing lines representing the body and head. The figure is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circle's perimeter.
Food and Drug Adrninistration 2098 Gaither Road Rockville MD 20850
APR 2 9 2005
EPS Bio Technology Corp. c/o Ms. Jennifer Reich US Agent Harvest Consulting Corporation 3892 South America West Trail Flagstaff, AZ 86001
K043245 Re:
K043243
Trade/Device Name: Easy Pain Supreme Self-Monitoring Blood Glucose System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA, JJX Dated: March 18, 2005 Received: March 25, 2005
Dear Ms. Reich:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becasil 3 ro(i) fan device is substantially equivalent (for the indications felerenced above and nave determined and marketed predicate devices marketed in interstate for use stated in the Cherosure) to regars actment date of the Medical Device Amendments, or to commence prov to May 20, 1976, the excordance with the provisions of the Federal Food, Drug, devices that have been reclassified in accessfired in assessor al of a premarket approval application (PMA). and Cosment Act (Act) that do not require approvine of the general controls provisions of the Act. The You may, merclore, market the device, solo, connual registration, listing of general controls provisions of the rict mercials comments of and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), II your device is classified (300 above) into 5. Existing major regulations affecting your device
it may be subject to such additional controls. Existing major regulation i It may be subject to such adultional controllar Enting Cargo, Co. 9
can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA can be found in Thie 21, Coub of I caeral suggest in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA s issualled of a backers.
that FDA has made a determination that your device complies with other requirements of the Act that FDA has made a decemmation the Journer Federal agencies. You must or any Federal statutes and regulations as annuding, but not limited to: registration and listing (21 comply with an the Ave 3 requirements 801 and 809); and good manufacturing practice and CI'K I all 807), laoching (21 CF ruality systems (QS) regulation (21 CFR Part 820).
7
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will anow you to begin manteang your and equivalence of your device to a legally premained notification. "The I D'A manig of ousleasification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, If you destions on the promotion and advertising of your device, please contact the Office of In of questions on the promotion and Safety at (240)276-0484. Also, please note the Pill o Diagnostic Dovies Brance to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I ou may outlif one getierers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Jean M. Cooper, MS, DUM
Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
8
Indications for Use
510(k) Number (if known): K043245
Easy Pain Supreme Self-Monitoring Blood Glucose System Device Name:
Indications For Use:
The Easy Pain Supreme Self-Monitoring Blood Glucose System is used by The Easy Pain Supreme Scir Monitonia Breakurement of glucose levels
individuals with diabetes. It is for the quantitative the offectiveness of diabete individuals with diabetes. It is for the quantitiation the effectiveness of diabetes
in fresh capillary whole blood, as an aid in monitoring the effectiveness of diabetes in froom oupliary on the home and in clinical settings.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Albeto Caz
Division Sign-Off
Office of In Vitro Diagnostic
Device Evaluation and Safety
510(k) K043245
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