(68 days)
Not Found
No
The summary describes a standard blood glucose monitoring system using test strips and a meter, with no mention of AI/ML terms, image processing, or data training/testing sets typically associated with AI/ML applications.
No.
The device is used to monitor glucose levels, aiding in the management of diabetes, but it does not directly treat the condition.
Yes
The device is described as "an aid in monitoring the effectiveness of diabetes management." Monitoring the effectiveness of treatment falls under the definition of a diagnostic device.
No
The device description explicitly lists hardware components such as a blood glucose meter, test strips, lancet, check strip, code card, and control solutions.
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 from fingerstick." This involves testing a biological sample (blood) outside of the body to gain information about a person's health status (glucose levels related to diabetes).
- Device Description: The system includes components like test strips and control solutions, which are typical for in vitro diagnostic devices that perform chemical or biological analyses on samples.
- Performance Studies: The document details analytical performance studies (precision, linearity, specificity) and comparison studies with a predicate device and a reference method (YSI). These types of studies are standard for demonstrating the performance and accuracy of IVD devices.
- Predicate Device: The mention of a predicate device (K043245; Easy Pain Supreme Self Monitoring Blood Glucose System) further confirms its classification as an IVD, as predicate devices are used for comparison in the regulatory submission process for new IVDs.
In summary, the device meets the definition of an IVD because it is used to examine a specimen (blood) obtained from the human body for the purpose of providing information for the diagnosis, monitoring, or treatment of a disease or condition (diabetes).
N/A
Intended Use / Indications for Use
The EasyPlus 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 from fingerstick, as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings.
Product codes
NBW, CGA, JJX
Device Description
The EasyPlus Self Monitoring Blood Glucose System is comprised of the EasyPlus Blood Glucose Meter, EasyPlus Glucose Test Strips, Auto Lancet, Check strip, code card and control solutions.
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
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Intended User / Care Setting
individuals with diabetes, 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
- Analytical performance:
a. Precision/Reproducibility:
Within-run: Testing conducted with 4 mL of heparin-treated blood with 6 different glucose concentration levels (30-50 mg/dL, 51-110 mg/dL, 111-150 mg/dL, 151-250 mg/dL, 251-400 mg/dL, and 401-550 mg/dL). Each sample measured 10 times. N=200 for each range, mean and SD reported for each range, with CV ranging from 2.2% to 6.2%.
Day to day: Three control solutions (Low, Normal, High) measured twice a day for a month. N=400 for each control level, mean, SD, and CV reported (Low CV=5.1%, Normal CV=2.7%, High CV=3.2%).
b. Linearity/assay reportable range:
A 25 mL blood sample treated with heparin was used, with B-D-glucose added to provide 7 different blood glucose levels (30-50 mg/dL, 51-80 mg/dL, 81-120 mg/dL, 121-200 mg/dL, 201-300 mg/dL, 301-400 mg/dL, and 400-550 mg/dL). 210 tests performed using 10 meters per strip lot. Linear regression: y = 0.9722x -0.1682, r^2 = 0.9956, Svx = 9.38, N = 630.
d. Detection limit: Data supported a reportable range of 30-550 mg/dL.
e. Analytical specificity: Interference testing conducted with select endogenous and exogenous substances as recommended by CLSI EP7-P. Interference observed from dopamine and L-dopa at recommended concentrations, and from acetaminophen, gentisic acid, and methvidopa at higher than therapeutic dosages. - Comparison studies:
a. Method comparison with predicate device: 205 people with diabetes performed fingerstick with EasyPlus. A healthcare professional performed tests on EasyPlus and YSI. Range of tested values 30-550 mg/dL.
Patient vs. YSI: y = 0.95x + 7.41, r^2= 0.976
Healthcare professional vs. YSI: y = 0.95x + 7.91, r^2= 0.971
Comparison with predicate device (EasyPlus vs. predicate device): linear regressions provided but not detailed.
Key Metrics
For Within-run precision:
3050 mg/dL: mean 56.3 mg/dL, SD 3.5 mg/dL, CV 6.2%110 mg/dL: mean 100.0 mg/dL, SD 4.5 mg/dL, CV 4.5%
51
111150 mg/dL: mean 134.0 mg/dL, SD 5.6 mg/dL, CV 4.2%250 mg/dL: mean 189.6 mg/dL, SD 5.2 mg/dL, CV 2.7%
151
251400 mg/dL: mean 313.5 mg/dL, SD 8.9 mg/dL, CV 2.8%550 mg/dL: mean 479.7 mg/dL, SD 10.4 mg/dL, CV 2.2%
401
For Day to day precision:
Low Control: mean 59.3 mg/dL, SD 3.0 mg/dL, CV 5.1%
Normal Control: mean 131.6 mg/dL, SD 3.5 mg/dL, CV 2.7%
High Control: mean 389.3 mg/dL, SD 12.4 mg/dL, CV 3.2%
Linearity: r^2 = 0.9956
Method comparison:
Patient vs. YSI: r^2= 0.976
Healthcare professional vs. YSI: r^2= 0.971
Predicate Device(s)
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.
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510(k) SUMMARY
This Summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of 21CFR §807.81(a)(3).
The assigned 510(K) number is : K061992
A. Submitter's information
SEP 1 9 2006
Company: EPS Bio Technology Corp. 2F, No. 49-2, Lane 2, Guang Fu Rd., Sec.2 Hsinchu City, Taiwan, Address: R.O.C. Contact Name: Mr. Y.C. Lei, General Manager 886-3-5752522 Phone: 886-3-5752552 Fax: Date Prepared: June 30, 2006
B. Purpose for Submission:
The Indication for use and fundamental scientific technology of the modified device has not changed. The changes are modified mechanical appearance of device, test range, test time and the labeling.
C. Measurand:
Glucose
- D. Type of Test: Quantitative; electrochemical biosensor
E. Proprietar y and Established Names:
EasyPlus Self Monitoring Glucose Test System
F. Common or Usual Name: Glucose Test System
G. Regulatory Information:
-
- Regulation section: 21 CFR 862.1345, Glucose Test System 21 CFR 862.1660, Quality control material (assayed and unassayed).
-
- Classification: Class II Class I. reserved
-
- Product code: NBW, System Test, Blood Glucose, Over the Counter
1
CGA, Glucose Oxidase, Glucose JJX, Single (Specified) Analyte Controls (Assayed and Unassayed)
-
- Panel: Chemistry 75
H. Intended Use:
-
- Intended use(s): see Indications for Use below
-
- Indication(s) for use:
The EasyPlus 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 from fingerstick, as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings.
-
- Special conditions for use statement(s): N/A
-
- Special instrument requirements: N/A
Device Description: 1.
The EasyPlus Self Monitoring Blood Glucose System is comprised of the EasyPlus Blood Glucose Meter, EasyPlus Glucose Test Strips, Auto Lancet, Check strip, code card and control solutions.
J. Substantial Equivalence Information:
-
- Predicate device name(s): Easy Pain Supreme Self Monitoring Blood Glucose System
-
- Device Company EPS Bio Technology Corporation
-
- Predicate 510(k) number(s): K043245
-
- Comparison with predicate:
| Similarities | ||
|---|---|---|
| Item | Device | Predicate |
| Detection method | Amperometry | Amperometry |
| Enzyme | Glucose oxidase | |
| (Aspergillus niger) | Glucose oxidase | |
| (Aspergillus niger) | ||
| Mediator | Potassium ferricyanide | Potassium ferricyanide |
2
| Similarities | ||
|---|---|---|
| Item | Device | Predicate |
| Electrode | Carbon electrode | Carbon electrode |
| Hematocrit range | 30-55% | 30-55% |
| Sample volume | $\geq 2.0$ uL | $\geq 2.0$ uL |
| Temperature range | 10-40°C | 10-40°C |
| Humidity range | R.H. $\leq$ 90% | R.H. $\leq$ 90% |
| Coding | Code card | Code card |
| Memory capability | 100 tests with date and | |
| time | 100 tests with date and | |
| time | ||
| Power | 1.5V (AAA) batteries | 1.5V (AAA) batteries |
| Battery life | Approx. 1000 tests | Approx. 1000 tests |
| Item | Device | Predicate |
|---|---|---|
| Test range | 30-550 mg/dL | 40-600 mg/dL |
| Test time | 5 seconds | 25 seconds |
| Size L x W x H (inch) | 3.2"x 2"x 0.7" | 2.9"x 2.1"x 0.7" |
| Weight | 1.6 oz (without batteries) | 1.8 oz (without batteries) |
K. Standard/Guidance Document Referenced (if applicable):
- CLSI EP5-A, Precision Performance of Clinical Chemistry Devices 1.
-
- CLSI EP6-P, Evaluation of the Linearity of Quantitative Analytical Methods; Proposed Guideline
-
- CLSI EP7-P, Interference Testing in Clinical Chemistry; Proposed Guideline
-
- ISO 15197:2003, In Vitro Diagnostic Test Systems - Requirements for Blood Glucose Monitoring Test Systems for Self Managing Diabetes Mellitus
-
- IEC 60601-1-2, Medical Electrical Equipment – Part 1: General Requirement for Safety; Electromagnetic Compatibility - requirements and Tests
- IEC 61010-1, Safety Requirements for Electrical Equipment for Measurement, 6. Control, and Laboratory Use - Part 1: General Requirements
-
- IEC 60601-2-101, Safety Requirements For Electrical Equipment for Measurement, Control, and Laboratory Use - Part 2-101: Particular Requirements for In Vitro Diagnostic (IVD) Medical Equipment
-
- IEC 60068-2-64, Environmental Testing- Part 2: Test Methods- Test Fh: Vibration, Broad-band Random (Digital Control) and Guidance
- IEC 61326 (2002-02) (for reference), Electrical Equipment for Measurement 9. Control, and Laboratory Use - EMC Requirements
-
- ISO 14971:2000, Medical Devices Application of Risk Management to Medical Devices
-
- ISO 15223:2000, Medical Devices Symbols to be Used With Medical Device Labels, Labeling, and Information to be Supplied
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- EN 376:2002, Information Supplied by the Manufacturer With In Vitro Diagnostic Reagents for Self Testing
-
- ISO 10993-1, Biological Evaluation of Medical Devices Part 1:Evaluation and Testing
3
14. EN 13640:2002 Stability Testing of In Vitro Diagnostic Reagents
L. Test Principle:
The EasyPlus Self Monitoring Blood Glucose System employs 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 qluconic 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 displayed on the meter screen after 5 seconds.
M. Performance Characteristics (if/when applicable):
-
- Analytical performance:
- a. Precision/Reproducibility:
Within-run - 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 6 different levels of glucose concentration for the test. Each of the samples was measured 10 times. The glucose concentration ranges were: 30-50 mg/dL, 51-110 mg/dL, 111-150 mg/dL, 151-250 mg/dL, 251-400 mg/dL, and 401~550 mg/dL.
| Range(mg/dL) | N | EasyPlus | ||
|---|---|---|---|---|
| mean(mg/dL) SD(mg/dL) | CV(%) | |||
| 30~50 mg/dL | 200 | 56.3 | 3.5 | 6.2 |
| 51~110 mg/dL | 200 | 100.0 | 4.5 | 4.5 |
| 111~150 mg/dL | 200 | 134.0 | 5.6 | 4.2 |
| 151~250 mg/dL | 200 | 189.6 | 5.2 | 2.7 |
| 251~400 mg/dL | 200 | 313.5 | 8.9 | 2.8 |
| 401~550 mg/dL | 200 | 479.7 | 10.4 | 2.2 |
'Day to day - 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.
| Control | n | mean (mg/dL) | SD (mg/dL) | CV (%) |
|---|---|---|---|---|
| Low | 400 | 59.3 | 3.0 | 5.1 |
| Normal | 400 | 131.6 | 3.5 | 2.7 |
| High | 400 | 389.3 | 12.4 | 3.2 |
b. Linearity/assay reportable range:
A blood sample of 25 mL was taken, treated with heparin vacuum tube, to be set
4
for a day. Testing was performed using whole blood supplemented with B-Dglucose to provide samples at seven different blood glucose levels (30-50 mg/dL, 51-80 mg/dL, 81-120 mg/dL, 121-200 mg/dL, 201-300 mg/dL, 301-400 mg/dL, and 400-550 mg/dL). A total of 210 tests were performed using 10 meters among the seven glucose ranges per each strip lot.
The linear regression was as follows: v = 0.9722x -0.1682, 2 = 0.9956, Svx = 9.38, N = 630
- Traceability, Stability, Expected values (controls, calibrators, or methods): C. Traceability referenced to NIST Standards, and it cleared with predicate device.
- d. Detection limit:
Data was provided to support a reportable range of 30-550 mg/dL.
- e. Analytical specificity:
Interference testing was conducted to determine the effect of select 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. The substances and concentrations of the interferents are recommended in CLSI EP7-P.
Interference from dopamine and L-dopa was observed when the recommended concentration of these drugs was reached in the blood. Interference was also observed in higher than therapeutic dosages of acetaminophen, gentisic acid, and methvidopa.
- f. Assay cut-off: N/A
2. Comparison studies:
- a. Method comparison with predicate device:
Two hundred and five people with diabetes performed a finger stick using the EasyPlus system. A healthcare professional then performed the test on the EasyPlus and the YSI. The range of tested values for these samples was 30-550 ma/dL.
| The linear regressions were as follows: | |
|---|---|
| Patient vs. YSI: | $y = 0.95x + 7.41, r^2= 0.976$ |
| Healthcare professional vs. YSI: | $y = 0.95x + 7.91, r^2= 0.971$ |
And compare with predicate device, the linear regressions was as follows: EasyPlus vs. predicate device:
- b. Matrix comparison: N/A
5
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 section 2.a.
-
- Clinical cut-off: N/A
5. Expected values/Reference range: Expected blood glucose levels for people without diabetes (refereced from Joslin Diabetes Manual):
| 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 |
| one hour after meals | less than 160 | less than 8.9 |
| two hours after meal | less than 120 | less than 6.7 |
| between 2 and 4 AM | greater than 70 | greater than 3.9 |
N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
O. Conclusion:
The EasyPlus Self Monitoring Blood Glucose System has the same intended use and similar technological characteristics as the Easy Pain Supreme Self Monitoring Blood Glucose System (K043245) marketed by EPS Bio Technology Corp., Moreover, bench testing contained in the submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the EasyPlus Self-Monitoring Blood Glucose System is substantially equivalent to the predicate devise.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 outstretched arms, representing care and protection. The figure is positioned to the right of the department's name, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA".
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 1 9 2006
General Manager EPS Bio Technology Corp. 2F, No. 49-2, Lane 2, Guang Fu Rd., Sec 2 Hsinchu City, Taiwan, China
Re: K061992
Mr. Y.C. Lei
Trade/Device Name: EasyPlus 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: August 18, 2006 Received: August 21, 2006
Dear Mr. Lei:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, 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,
Alberto Garcia, Ph.D.
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K061992
Device Name: EasyPlus Self-Monitoring Blood Glucose System ·
Indications For Use:
The EasyPlus 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 from fingerstick, as an aid in monitoring the effectiveness of diabetes management in 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)
t C)
V
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
C.H.
Division Sign-Off
Divise of In Vitro Diagnostic Device
Office of In Vitro Diagnostic Device
In Coloral Cafety Office tion and Safety
510(k) K061992