EASYPLUS MINI R2N SELF MONITORING GLUCOSE TEST SYSTEM
Device Facts
| Record ID | K081796 |
|---|---|
| Device Name | EASYPLUS MINI R2N SELF MONITORING GLUCOSE TEST SYSTEM |
| Applicant | Eps Bio Technology Corp. |
| Product Code | NBW · Clinical Chemistry |
| Decision Date | Jan 23, 2009 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1345 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
The EasyPlus mini R2N Self Monitoring Blood Glucose Test System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. The EasyPlus mini R2N Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. EasyPlus mini R2N Blood Glucose Test Strips must be used with the EasyPlus mini R2N Meter. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. The EasyPlus mini R2N Blood Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. EasyPlus mini R2N Blood Glucose Test Strips must be used with the EasyPlus mini R2N Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). They are indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. The EasyPlus mini R2N Glucose Normal/High Control Solution are for use with the EasyPlus mini R2N meter and EasyPlus mini R2N Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results.
Device Story
System measures glucose in capillary whole blood via electrochemical biosensor. User applies blood to disposable test strip; glucose oxidase catalyzes oxidation of glucose; mediator transfers electrons to carbon electrode, generating current proportional to glucose concentration. Meter processes current to display result in 5 seconds. Used at home by patients or in clinics by professionals. Output aids diabetes management. System includes meter, test strips, auto-lancet, check strip, and control solutions. Benefits include rapid, quantitative monitoring of blood glucose levels.
Clinical Evidence
Bench testing only. Precision/reproducibility studies (N=200-400) showed CVs ranging from 2.10% to 4.44%. Linearity confirmed (R2=0.9950). Method comparison (N=165) against YSI 2300 analyzer met ISO 15197 accuracy requirements: 95% of results within ±15 mg/dL (for <75 mg/dL) or ±20% (for ≥75 mg/dL). Hematocrit interference tested (20-60% range).
Technological Characteristics
Amperometric glucose oxidase assay; carbon electrodes; potassium ferricyanide mediator. Dimensions: 3.5" x 2.1" x 0.97". Power: 3V (2x CR2032 batteries). No-code calibration. Standalone device; no wireless/data transmission. Standards: CLSI EP5-A, EP6-A, EP7-A; ISO 15197:2003; ISO 14971:2000; EN 13640:2002.
Indications for Use
Indicated for persons with diabetes (home/OTC) or clinical settings to monitor diabetes control effectiveness. Not for critically ill, dehydrated, hyperosmolar, or neonatal patients. Alternative site testing only during steady state.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- EasyPlus Self-Monitoring Blood Glucose System (k061992)
Related Devices
- K103116 — AP-2000, AP-2010, AND AP-2020 BLOOD GLUCOSE MONITORING SYSTEM · Bestgen Biotech Corp. · Mar 13, 2012
Submission Summary (Full Text)
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K0M7296
JAN 2 3 2009
# EasyPlus mini R2N Self Monitoring Glucose Test System 510(k) SUMMARY
## A Submitter's information
Company EPS Bio Technology Corp Address 2F, No 49-2, Lane 2, Guang Fu Rd , Sec 2 Hsinchu City, Tawan, R O C Contact Name Mr Y C Leı, General Manager 886-3-5752522 Phone Fax 886-3-5752552
## B Measured
Glucose
- C Type of Test Quantitative, electrochemical brosensor
- D Proprietary and Established Names EasyPlus mını R2N Self-Monitoring Blood Glucose Test System
## E Common or Usual Name Glucose Test System
### ட Regulatory Information
- Regulation section ﮩ 21 CFR 862 1345, Glucose Test System 21 CFR 862 1660, Quality control materials (assayed and unassayed)
- 2 Classification Class II Class I, reserved
### ന Product code
NBW, System Test, Blood Glucose, Over the Counter CGA, Glucose Oxidase, Glucose JJX, Single (Specified) Controls (assayed and Unassayed)
- 4 Panel Chemistry 75
## G Intended Use
- 1 Intended use(s) See Indications for Use below
- ଧ Indication(s) for use
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The EasvPlus mını R2N Self Monitorınq Blood Glucose Test System The EasyPlus mını R2N Self Monitoring Blood Glucose Test System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm Testing is done outside the body (In Vitro diagnostic use) It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control
## The EasyPlus mini R2N Meter
The EasyPlus mini R2N Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm EasyPlus mini R2N Blood Glucose Test Strips must be used with the EasyPlus mומו R2N Meter Testing is done outside the body (In Vitro diagnostic use) It is indicated for use at home (over the counter [OTC]) by persons with drabetes, or in clinical settings by healthcare professionals, as an and to monitor the effectiveness of diabetes control
## The EasyPlus mini R2N Blood Glucose Test Strips
The EasyPlus min: R2N Blood Glucose Test Strips , are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm EasyPlus mini R2N Blood Glucose Test Strips must be used with the EasyPlus mini R2N Blood Glucose Meter Testing is done outside the body (In Vitro diagnostic use) They are indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control
## The EasyPlus mını R2N Glucose Normal/High Control Solution
For use with the EasyPlus mını R2N meter and EasyPlus mını R2N Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results
- Special conditions for use statement(s) က
For Over-the-Counter use Not for use with newborns
Alternate site testing (AST) can only be used during steady-state blood glucose conditions AST (forearm) should only be performed under the following conditions
- Testing before a meal
- ♦ In a fasting state
- · Two hours or more after a meal
- ← Two hours or more after insulın dosing
- ♦ Two hours after physical activity
#### Special instrument requirements ব
EasyPlus mını R2N Blood Glucose Meter
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## H Device Description
The EasyPlus min: R2N Self-Monitoring Blood Glucose System consists of the EasyPlus mını R2N Blood Glucose Meter, EasyPlus mını R2N Glucose Test Strips, Auto-Lancet Device, Check Strip and Control Solution (Please refer to the IFU for the product picture)
#### l Substantial Equivalence Information
- 1 Predicate device name(s) EasyPlus Self-Monitoring Blood Glucose System
- 2 Device Company EPS Bio Technology Corporation
- ന Predicate 510(k) number(s) k061992
- Comparison with predicate র্ব
| Similarities | | |
|-------------------|----------------------------------------|----------------------------------------|
| Item | Device | Predicate |
| Detection method | Amperometry | Amperometry |
| Enzyme | Glucose oxidase<br>(Aspergillus niger) | Glucose oxidase<br>(Aspergillus niger) |
| Mediator | Potassium ferricyanide | Potassium ferricyanide |
| Electrode | Carbon electrode | Carbon electrode |
| Hematocrit range | 20-60% | 30-55% |
| Sample volume | $> 0.6 uL$ | $> 2.0 uL$ |
| Temperature range | 10-40°C | 10-40°C |
| Humidity range | RH ≤ 90% | RH ≤ 90% |
| Coding | One Code | Code card |
| Memory capability | 480 tests with date and time | 100 tests with date and time |
| Power | 3V 2X CR2032 batteries | 1 5V (AAA) batteries |
| Battery life | Approx 2000 tests | Approx 1000 tests |
| Differences | | |
|-----------------------|-----------------------------|----------------------------|
| Item | Device | Predicate |
| Test range | 20-600 mg/dL | 30-550 mg/dL |
| Test time | 5 seconds | 5 seconds |
| Size L x W x H (inch) | 3 5"x 2 1"x 0 97" | 3 2"x 2"x 0 7" |
| Weight | 2 05 oz (without batteries) | 1 6 oz (without batteries) |
- J Standard/Guidance Document Referenced (If applicable)
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- CLSI EP5-A, Precision Performance of Clinical Chemistry Devices 1
- CLSI EP6-A, Evaluation of the Linearity of Quantitative Analytical Methods, Proposed 2 Guideline
- 3 CLSI EP7-A. Interference Testing in Clinical Chemistry, Proposed Guideline
- ISO 15197 2003, In Vitro Diagnostic Test Systems Requirements for Blood ಗ Glucose Monitoring Test Systems for Self Managing Diabetes Mellitus
- 5 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, 7 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, 8 Broad-band Random (Digital Control) and Guidance
- 9 IEC 61326 (2002-02) - (for reference), Electrical Equipment for Measurement Control, and Laboratory Use - EMC Requirements
- ISO 14971 2000, Medical Devices Application of Risk Management to Medical 10 Devices
- ISO 15223 2000. Medical Devices Symbols to be Used With Medical Device Labels, 11 Labeling, and Information to be Supplied
- 12 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 13 Testing
- 14 EN 13640 2002 Stablity Testing of in Vitro Diagnostic Reagents
## K Test Principle
The EasyPlus mını R2N Self-Monitoring Blood Glucose System employs a dısposable 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 acıd 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 EasyPlus mini R2N Glucose Meter and displayed on the screen after 5 seconds
## L Performance Characteristics (if/when applicable)
- Analytical performance 1
- a Precision/Reproducibility
Within-run - The testing was used by venous blood, which comes with heparın blood collection tube Glucose was added to the blood to prepare 6 different levels of glucose
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concentration for the testing The glucose concentration ranges were 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 Meter x10 tests x 2 lots =200)
| Range (mg/dL) | N | Lot 021074801 | | |
|----------------------------|-----|-----------------|---------------|--------|
| | | Mean<br>(mg/dL) | SD<br>(mg/dL) | CV (%) |
| 20~50 mg/dL | 100 | 53 8 | 1 57 | 2 92% |
| 51~110 mg/dL | 100 | 76 0 | 1 98 | 2 61% |
| 111~150 mg/dL | 100 | 126 8 | 3 28 | 2 59% |
| 151~250 mg/dL | 100 | 214 6 | 7 05 | 3 29% |
| 251~400 mg/dL | 100 | 363 0 | 8 17 | 2 25% |
| 401~600 mg/dL | 100 | 561 6 | 12 39 | 2 21% |
| Normal<br>control solution | 100 | 111 6 | 3 92 | 3 51% |
| Range (mg/dL) | N | Lot 021075201 | | |
|----------------------------|-----|-----------------|---------------|--------|
| | | Mean<br>(mg/dL) | SD<br>(mg/dL) | CV (%) |
| 20~50 mg/dL | 100 | 55 9 | 2 48 | 4 44% |
| 51~110 mg/dL | 100 | 77 5 | 2 80 | 3 62% |
| 111~150 mg/dL | 100 | 132 3 | 3 27 | 2 47% |
| 151~250 mg/dL | 100 | 221 2 | 5 92 | 2 67% |
| 251~400 mg/dL | 100 | 368 9 | 7 74 | 2 10% |
| 401~600 mg/dL | 100 | 563 4 | 13 96 | 2 48% |
| Normal<br>control solution | 100 | 119 7 | 4 38 | 3 66% |
## Day-to-Day Precision
10 Meters, 2 lots of test strip, and 3 control solutions of Low, Normal and High were prepared Each control was tested twice a day, once in the morning and once in the afternoon for 10 days (N=10 Meter x 2 Lots x 2 tests x10 days =400),
| Control<br>solution | N | mean<br>(mg/dL) | SD<br>(mg/dL) | CV (%) |
|---------------------|-----|-----------------|---------------|--------|
| Low | 400 | 47 1 | 1 67 | 3 54% |
| Normal | 400 | 122 2 | 4 62 | 3 78% |
| High | 400 | 398 5 | 10 57 | 2 65% |
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#### Linearity/assav reportable range o
A blood sample of 25 mL was taken, treated with heparın vacuum tube, to be set for a day Testing was performed using whole blood supplemented with ß -Dglucose to provide samples at 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 210 tests were performed using 10 meters among the seven glucose ranges per each strip lot
The linear regression was as follows
| N= | 630 (210X3Lot) |
|-------------|----------------|
| Slope | 1 0450 |
| Y-intercept | -1 2505 |
| R2 | 0 9950 |
- Traceability, Stability, Expected values (controls, calibrators, or methods) C The device is traceable to a laboratory YSI 2300D analyzer Calibrate YSI 2300D analyzer before its use and the calibrators are manufactured gravimetrically and provided from the instrument supplier
Execute the validation of YSI 2300D analyzer by using this international standard reference material (NIST 965a) every year
Stability characteristics of the Normal and High control solutions were determined by using real-time stability studies to determine the storage stability at room temperature to be 19 months
- 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 concentrations and hematocrit levels of venous blood samples from several donors The venous blood samples spiked to 4 glucose concentration levels described in the following table The hematocrit levels were adjusted to 0%, 20%, 40%, 50%, 60% and 70% Each sample was run n=10 for each strip lot and the maxımum percent bias was calculated compared to the 40% hematocrit samples The acceptance criteria of Hematocrit interference test is bias ≤15 mg/dL when glucose concentration ≤75 mg/dL and bras ≤ 15% when glucose concentration > 75 mg/dL Results are summarized in table as below After analysıs of this studie, the claim for the device was for use with samples having hematocrit concentrations ranging from 20% to 60%
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| Strip lot # | Hematocrit<br>% | YSI Labeled Value, mg/dL | Slope | Y-<br>intercept | R2 | % Bias |
|-------------|-----------------|--------------------------|--------|-----------------|--------|--------|
| 012072901 | 0% | 54 85 122 5 267 0 494 0 | 0 9874 | 51 745 | 0 9697 | 29 51 |
| | 20% | 45 25 119 5 269 0 497 0 | 0 9461 | 7 2842 | 0 9982 | -1 18 |
| | 40% | 47 55 127 5 270 0 505 5 | 0 9896 | -3 4003 | 0 9982 | -2 21 |
| | 50% | 47 50 125 5 264 0 504 0 | 0 9529 | -4 1426 | 0 9974 | -4 61 |
| | 60% | 50 05 120 5 264 5 509 5 | 0 9296 | 7 5074 | 0 9992 | -0 47 |
| | 70% | 50 55 118 0 258 5 505 0 | 0 7149 | 17 894 | 0 9944 | -13 46 |
| 012072701 | 0% | 54 85 122 5 267 0 494 0 | 1 0812 | 43 438 | 0 9811 | 34 01 |
| | 20% | 45 25 119 5 269 0 497 0 | 0 9400 | 8 8823 | 0 9968 | -0 45 |
| | 40% | 47 55 127 5 270 0 505 5 | 1 0130 | -7 8632 | 0 9981 | -2 75 |
| | 50% | 47 50 125 5 264 0 504 0 | 0 9423 | -1 8592 | 0 9992 | -3 97 |
| | 60% | 50 05 120 5 264 5 509 5 | 0 9377 | 4 4687 | 0 9985 | -0 59 |
| | 70% | 50 55 118 0 258 5 505 0 | 0 6798 | 26 641 | 0 9973 | -10 74 |
### Assay cut-off f
N/A
- Comparison studies 2
a Method comparison with predicate device
Site 1,2,3.
Accuracy / Method comparison at sites 1,2,3
A total 156 diabetes patients performed a finger stick and forearm using the EasyPlus mini R2N system at 3 sites A healthcare professional then performed the test on the EasyPlus mini R2N and the YSI 2300 analyzer The range of tested values for these samples was 74 2-486 mg/dL In order to fully cover the measuring range, 9 of the samples were spiked with glucose or allowed to glycolyze The total 165 (156+9) samples ranged in concentration from 32 to 591 mg/dL on the EasyPlus min: R2N SMBG system The distribution of total 165 samples is described as below
| Glucose<br>concentration | Number of sample | % of sample |
|--------------------------|------------------|-------------|
| <50mg/dL | 6 | 3 6 |
| 50-80 mg/dL | 8 | 4 8 |
| 81-120 mg/dL | 49 | 29 7 |
| 121-200 mg/dL | 57 | 34 5 |
| 201-300 mg/dL | 33 | 20 0 |
| 301-400 mg/dL | 5 | 3 0 |
| >400 mg/dL | 7 | 4 2 |
Meter versus YSI at each site met the ISO 15197 requirement of ninety-five percent (95 %) of the individual glucose results fallıng withın ±15 mg/dL of the
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results of the manufacturer's measurement procedure at glucose concentrations for samples <75 mg/dL and within ± 20 % at glucose concentrations ≥75 mg/dL These results are summarized in the table below
System accuracy results for glucose concentrations < 75 mg/dL
| Within ±5mg/dL | Within ±10mg/dL | Within ±15mg/dL |
|----------------|-----------------|-----------------|
| 7/8(87.5%) | 7/8(87.5%) | 8/8(100.0%) |
System accuracy results for glucose concentrations > 75 mg/dL
| Within ±5% | Within ±10% | Within ±15% | Within ±20% |
|----------------|------------------|-----------------|------------------|
| 56/157(35 67%) | 103/157 (65 61%) | 138/157(87 90%) | 151/157 (96 18%) |
Method comparison studies were performed by using alternate site testing (AST) samples compared to professional finger stick samples The studies were performed by using professional and participant AST samples take from the forearm
The linear regressions were as follows
| Comparison | N | Range(mg/dL) | Slope and Y-intercept | R2 |
|-------------------------------------|-----|--------------|-----------------------|--------|
| Finger vs YSI (professionals) | 156 | 74 2-486 | $Y=1.0470X-3.9092$ | 0.9540 |
| Finger vs YSI (lay users) | 156 | 74 2-486 | $Y=1.0307X-2.8876$ | 0.9471 |
| Thenar vs Finger(professionals) | 156 | 71 0-566 | $Y=1.0113X+3.2591$ | 0.9610 |
| Thenar vs Finger(lay users) | 156 | 71 0-566 | $Y=1.0072X+6.7177$ | 0.9539 |
| Hypothenar vs Finger(professionals) | 156 | 71 0-566 | $Y=1.0642X-2.7188$ | 0.9617 |
| Hypothenar vs Finger(lay users) | 156 | 71 0-566 | $Y=1.0421X+1.0330$ | 0.9684 |
| Forearm vs Finger(professionals) | 156 | 71 0-566 | $Y=0.9144X+16.121$ | 0.9448 |
| Forearm vs Finger (lay users) | 156 | 71 0-566 | $Y=0.9410X+15.266$ | 0.9163 |
And compare with predicate device, the linear regressions was as follows EasyPlus mini R2N vs predicate device Y = 1 0431X -1 1192, R = 0 9785
- Matrix companson b N/A
- Clinical studies ತಿ
- Clinical Sensitivity a N/A
- Clinical specificity ﻫ N/A
- c Other clinical supportive data (when a and b are not applicable) see section 2 a
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### 4 Clinical cut-off N/A
#### ട് Expected values/Reference range
Expected blood glucose levels for people without diabetes (refereced from American Diabetes Associations Standards of Medical Care for Patients with Diabetes Mellitus, Diabetes Care, 25(2002), p S37)
| Time | Range (mg/dL) |
|-------------------------|---------------|
| Before meals or Fasting | 70-110 |
| 2 hour after meals | Less than 120 |
## N Proposed Labeling
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809 10
## O Conclusion
ן
The EasyPlus mini R2N Self Monitoring Blood Glucose System has the same intended use and sımılar technological characteristics as the EasyPius Self Monitoring Blood Glucose System (k061992) marketed by EPS Blo 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 mini R2N Self-Monitoring Blood Glucose System is substantially equivalent to the predicate devise
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Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
EPS BIO Technology Corp c/o Y C Leı General Manager 2F No 49-2, Lane 2, Guang Fu Road, Sec 2 Hsınchu Cıty, 30071 Tarwan, ROC
JAN 2 3 2009
k081796 Re
Trade Name EasyPlus mını R2N Self-Monitoring Blood Glucose Test System Regulation Number 21 CFR 862 1345 Regulation Name Glucose Test System Regulatory Class Class II Product Codes NBW. CGA. JJX Dated January 9, 2009 Received January 12, 2009
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 (OS) 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 (301) 594-3084 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/dsma/dsmamain html
Sincerely yours.
Coy C. Hh
Courtney C Harper, Ph D Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
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### Indication for Use
510(k) Number (if known) k081796 Device Name EasyPlus mini R2N Indication For Use
The EasyPlus min1 R2N Self Monitoring Blood Glucose Test System
The EasyPlus mini R2N Self Monitoring Blood Glucose Test System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm Testing is done outside the body (In Vitro diagnostic use) It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an and to monitor the effectivemess of diabetes control
### The EasyPlus mini R2N Meter
The EasyPlus mini R2N Meter is intended for the quantitative measurement of glucose un fresh capillary whole blood samples drawn from the fingertips or forearm EasyPlus mini R2N Blood Glucose Test Strips must be used with the EasyPlus min R2N Meter Testing is done outside the body (In Vitro diagnostic use)
It is indicated for use at home (over the counter [OTC]) by persons with drabetes, or in clinical settings by healthcare professionals, as an and to monitor the effectiveness of diabetes control
### The EasyPlus mini R2N Blood Glucose Test Strips
The EasyPlus mini R2N Blood Glucose Test Strips , are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertups or forearm EasyPlus mini R2N Blood Glucose Test Strips must be used with the EasyPlus mini R2N Blood Glucose Meter Testing is done outside the body (In Vitro diagnostic use) They are indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control
### The EasyPlus mini R2N Glucose Normal/High Control Solution
For use with the EasyPlus min R2N meter and EasyPlus mini R2N Blood Glucose Test Strips as a quality control check to venfy the accuracy of blood glucose test results
Prescription Use V (21 CFR Part 801 Subpart D) Over the Counter Use V (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE, CONTINUE ON ANOTHER PAGE IF NEEDED)
And/Or
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Carol C. Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K081796
