DS-A BLOOD GLUCOSE MONITORING SYSTEM

K082965 · Alliance International Co., Ltd. · CGA · Dec 7, 2009 · Clinical Chemistry

Device Facts

• Record ID: K082965
• Device Name: DS-A BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Alliance International Co., Ltd.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Dec 7, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The A-CHECK DS-A Blood Glucose Monitoring System is used with DS-A Test Strips and 3-level Controls for the measurement of glucose in fresh capillary whole blood from the finger. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by person with diabetes, or in clinical setting by health care professionals, as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for neonates. The DS-A Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. DS-A Test Strips must be used with the A-CHECK DS-A Blood Glucose Monitoring System. 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. They are not intended for the diagnosis of or screening for diabetes mellitus, and are not intended for use on neonates. The Alliance Blood Glucose 3 levels Control Solution are for use with the A-CHECK DS-A Blood Glucose Monitoring System and DS-A Test Strips as a quality control check to verify the accuracy of blood glucose test results.

Device Story

System measures glucose in fresh capillary whole blood via fingerstick; utilizes DS-A test strips and meter. Principle: glucose oxidase (GOD) electrochemical biosensor; electrons released during reaction generate current proportional to glucose concentration. Meter converts electronic signal to concentration; displays result. User inserts lot-specific calibration card into meter to set coefficients. Used by patients (home) or professionals (clinic). Output: quantitative blood glucose concentration. Benefits: aids diabetes management. System includes meter, test strips, lancets, and control solutions for accuracy verification.

Clinical Evidence

Clinical study with 150 lay users at three physician office laboratories; subjects performed self-testing using labeling. Results compared to YSI 2300 reference. Accuracy met ISO 15197:2003 standards: 100% of results within ±15 mg/dL (for <75 mg/dL) and 100% within ±20% (for ≥75 mg/dL). Regression: y=0.954x + 0.3382, r²=0.996. Ease-of-use survey showed high user comprehension (scores 4.34-4.89/5).

Technological Characteristics

Electrochemical biosensor with carbon electrodes; glucose oxidase (GOD) enzyme. Meter weight 56g. Coding via code card. Measurement range 20-600 mg/dL. Connectivity: 360 test result memory. Operates on capillary whole blood.

Indications for Use

Indicated for persons with diabetes (home/OTC) or clinical settings for monitoring blood glucose effectiveness. Not for neonates, diagnosis/screening of diabetes, alternative site testing, or critically ill/dehydrated/shock patients.

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

• Roche Accu-Chek Aviva System (k043474)

Submission Summary (Full Text)

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#### 510(K) Summary of Safety and Effectiveness II. (Per 21 CFR 807.92)

### 2.1. General Information Establishment

| | Date Prepared: | September 28, 2008 | | DEC - 7 2009 |
|--------|-----------------|-------------------------------------------------------------------|--------------------------------|--------------|
| | Manufacturer: | ALLIANCE International Co., Ltd. | | |
| | Address: | No.54, Ying Tao Rd. Yinge Town, Taipei County, 23942, Taiwan, ROC | | |
| | Owner Number: | 9099902 | | |
| | Contact Person: | Dr. Jen, Ke-Min | E-mail: [e-mail] | |
| | | 886-3-5208829 (Tel); 886-3-5209783 (Fax) | | |
| | Address: | No.58, Fu Chiun Street, Hsin Chu City, 30067, Taiwan, ROC | | |
| Device | | | | |

| ● Proprietary Name: | DS-A Blood Glucose Monitoring System |
|------------------------|---------------------------------------------------------|
| ● Common Name: | Blood Glucose Monitoring System |
| ● Classification Name: | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER, Class II |
| ● Product Code: | NBW |

# 2.2. Safety and Effectiveness Information

- . Predicate Device: Claim of Substantial Equivalence (SE) is made to ACCU-CHEK Aviva System (k043474).
- Based on an electrochemical biosensor technology ● Device Description: and the principle of capillary action, DS-A Blood Glucose Monitoring System only needs a small amount of blood. Capillary action at the end of the test strip draws the blood into the action chamber and your blood glucose result is precisely and displayed in 6 seconds.

The Draw-In blood glucose test strip is designed to provide an easy, accurate method for the determination of blood glucose in fingertip capillary whole blood. When the blood is applied to the edge of reaction zone, the blood is drawn into the reaction chamber and will display a reading on the meter. Only a small amount of blood is needed. The test strip for the quantitative measurement of blood glucose in the range is from 20-600 mg/dL (1.1-33.3 mmol/L).

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#### Intended Use: .

The A-CHECK DS-A Blood Glucose Monitoring System is used with DS-A Test Strips and 3-level Controls for the measurement of glucose in fresh capillary whole blood from the finger. Testing is done outside the body ( in vitro diagnostic use). It is indicated for use at home ( over the counter [OTC] ) by person with diabetes, or in clinical setting by health care professionals, as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

The DS-A Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. DS-A Test Strips must be used with the A-CHECK DS-A Blood Glucose Monitoring System. 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. They are not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

The Alliance Blood Glucose 3 levels Control Solution are for use with the A-CHECK DS-A Blood Glucose Monitoring System and DS-A Test Strips as a quality control check to verify the accuracy of blood glucose test results.

#### Substantial Equivalence (SE) ●

A claim of substantial equivalence is made to ACCU-CHEK Aviva System Both of them have the same working principle and (k043474). The differences are coding method, sample volume, meter technologies. dimension, weight, HCT range, and memory data number. Besides, the subject device is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger but the predicate device can test whole blood include traditional fingertip site along with palm, forearm, upper arm, thigh, and calf. Thus the differences are due to the feature design aspects, not relating to the safety or effectiveness aspects. They are substantially equivalent.

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| | Differences | |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Items | A-CHECK DS-A<br>(Alliance International )<br>Subject Device (k082965) | Accu-Chek Aviva (Roche)<br>Predicate Device (k043474) |
| Test Principle | GOD Electrochemical biosensor with<br>carbon electrodes | GDH Electrochemical |
| Meter Weight | 56 g | 60 g |
| Memory Storage | 360 test results | 500 blood glucose results |
| Meter Coding | Code Card | Code Key |
| Operating<br>Temperature | 14 to 40 °C | 6 to 44 °C |
| Strip Storage<br>Temperature | 4 to 32 °C | 2 to 32 °C |
| Limitations | A-Check Draw-In test strips are<br>designed for use with fresh capillary<br>whole blood sample. Do Not use<br>serum or plasma samples.<br>1. It should not be used in Intensive<br>Care settings or if the patient is<br>dehydrated, hypotensive, hypoxic,<br>in diabetic ketoacidosis, in shock, or<br>in a hyperglycemic/hyperosmolar<br>state.<br>2. Hematocrit: Variation in sample<br>hematocrit between 30% and 55%<br>has no significant effect on test<br>results. Very high (above 55%) and<br>very low (below 30%) hematocrit<br>can cause inaccurate results.<br>3. Neonates: Do not use Draw-In test<br>strips to test neonates. The<br>performance of this system has not<br>been validated with neonatal<br>samples.<br>4. Blood concentration of Ascorbic<br>Acid > 1.2mg/dL or Uric Acid ><br>7mg/dL will cause overestimation of<br>blood glucose results.<br>5. Therapeutic levels of L-dopa<br>(>10mg/dL) or Dopamine (><br>30mg/dL) may result in inaccurate<br>(elevated) glucose readings with the<br>system.<br>6. Acetaminophen (<20mg/dL),<br>Ibuprofen (<40mg/dL).<br>Tetracycline (< 0.4mg/dL),<br>Tolbutamide (<100mg/dL),<br>Cholesterol (<500mg/dL), and<br>Creatinine (<30mg/dL) may not | 1. The injection or infusion of solution<br>containing galactose or maltose<br>(present in some human<br>immunoglobulin preparations) may<br>cause overestimation of blood<br>glucose results.<br>2. Blood concentrations galactose><br>10mg/dL or maltose > 13 mg/dL will<br>cause overestimation of blood<br>glucose results.<br>3. Do not use during a xylose<br>absorption test.<br>4. Lipemic samples in excess of 4800<br>mg/dL may produce elevated results.<br>5. In situations of decreased peripheral<br>blood flow, fingerstick blood testing<br>may not be appropriate as it may not<br>reflect the true physiological state.<br>Examples would include, but are not<br>limited to: severe dehydration caused<br>by diabetic ketoacidosis or the<br>hyperglycemic hyperosmolar<br>nonketotic state, hypotension, shock<br>severe congestive heart failure, or<br>peripheral vascular disease.<br>6. Blood glucose determination with<br>venous blood must be performed<br>within 30 minutes of ample<br>collection.<br>7. For best results with venous blood,<br>the following<br>anticoagulants/preservation is<br>recommended: heparin or EDTA.<br>Serum separator tubes are acceptable<br>if whole blood is used immediately,<br>lodoacetate or fluoride-containing<br>anticoagulants are not recommended.<br>8. Refrigerated samples should be |

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#### . Synopsis of Test Methods and Results

Pre-clinical and clinical data are employed upon submission of this 510(K) premarket notification according to the Guidance Document for In Vitro Diagnostic Test System; Guidance for Industry and FDA document provided by CDRH/ FDA.

# For Home Users

The table below was based on a study done with 150 patients to see how well the A-Check DS-A Blood Glucose Monitoring System compared to the YSI 2300.

Image /page/3/Figure/4 description: This image is a scatter plot titled "Lay User". The x-axis is labeled "YSI 2300" and ranges from 0 to 450. The y-axis is labeled "DS-A Meter" and ranges from 0 to 450. The data points are clustered around a diagonal line, indicating a positive correlation between the two variables.

## Results for glucose concentration < 75mg/dL (4.2 mmol/L)

| Within ± 5<br>mg/dL | Within ± 10<br>mg/dL | Within ± 15<br>mg/dL |
|---------------------|----------------------|----------------------|
| 15/18 (83.3%) | 18/18 (100%) | 18/18 (100%) |

Results for glucose concentration ≥ 75mg/dL (4.2 mmol/L)

| Within ±<br>5% | Within ±<br>10 % | Within ±<br>15 % | Within ±<br>20 % |
|----------------|------------------|------------------|------------------|
| 83/132 | 129/132 | 131/132 | 132/132 |
| (62.9%) | (98%) | (99.2%) | (100%) |

| | A-CHECK DS-A Meter vs. YSI analyzer | | | |
|-----|-------------------------------------|-----------|-------|--|
| n | Slope | Intercept | R2 | |
| 150 | 0.954 | 0.3382 | 0.996 | |

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# Precision (Repeatability Precision)

To compare the precision of Draw-In series test strips and the YSI 2300 STAT Plus 1M glucose analyzer, oxygenated Heparin-venous blood, properly reconstituted with exogenous glucose to a final concentration of 40, 80, 120, 200, and 300 mg/dL. 40 tests of Draw-In series test strips were performed with each glucose concentration. The results obtained were as follows:

| Glucose<br>Concentrations(mg/dL) | 40 | 80 | 120 | 200 | 300 |
|----------------------------------|------|------|------|------|------|
| Number of Tests | 40 | 40 | 40 | 40 | 40 |
| AVG (mg/dL) | 42 | 88 | 133 | 211 | 329 |
| S.D. (mg/dL) | 2.5 | 4.8 | 7.5 | 5.1 | 8.8 |
| C.V.% | 5.9% | 4.4% | 4.0% | 2.3% | 2.5% |

### Linearity

A-CHECK DS-A Blood Glucose Meter comparison with YSI 2300. 2 lots of Draw-In test strips were tested to assess the accuracy of the A-CHECK DS-A Blood Glucose Monitoring System by comparing to the reference method (YSI 2300) using venous whole blood concentrations between 20 and 600 mg/dL. The linear regression correlations are as follows:

| Lot | Slope | Intercept | r | R2 |
|-----|-------|------------|-------|-------|
| 1 | 1.02 | -2.1 mg/dL | 0.996 | 0.993 |
| 2 | 1.01 | 2.5 mg/dL | 0.997 | 0.994 |

Y= A-CHECK DS-A Blood Glucose Meter X= YSI 2300

#### Accuracy

Accuracy (A-CHECK DS-A Blood Glucose Meter) comparison with YSI: 1 lot of Draw-In test strips were tested to assess the accuracy of the A-CHECK DS-A Blood Glucose Monitoring System by comparing to the reference method (YSI 2300) using whole blood concentrations. The table below was based on a study done with 178 patients getting samples by professionals to see how well the A-Check DS-A Blood Glucose Monitoring System compared to the YSI 2300. The accuracy regression correlations are as follows:

Image /page/4/Figure/9 description: The image shows a scatter plot comparing YS12300 and A-CHECK DS-A measurements in whole blood. The plot includes a linear regression line with the equation y = 1.0032x + 4.5469 and an R-squared value of 0.9938. The plot also shows dashed lines representing a 20% deviation from the line of identity (X=Y). The sample size is n=178, with 0 values out of range and a CV% of 2.97.

YSI2300 VS. A-CHECK DS-A (Whole Blood)

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## A-CHECK DS-A System accuracy results for glucose concentration < 4.2 mmol/L < < 75mg/dL >

| Within ± 5 mg/dL | Within ± 10 mg/dL | Within ± 15 mg/dL |
|------------------|-------------------|-------------------|
| 16/32 (50.0%) | 25/32 (78.1%) | 32/32 (100%) |

A-CHECK DS-A System accuracy results for glucose concentration≥ 4.2 mmol/L < ≥75mg/dL >

| Within ± 5% | Within ± 10% | Within ± 15% | Within ± 20% |
|-----------------|-----------------|-----------------|------------------|
| 102/146 (69.9%) | 124/146 (84.9%) | 136/146 (93.2%) | 146/146 (100.0%) |

| Lot | Slope | Intercept | r | R2 |
|-----|-------|-----------|-------|-------|
| 1 | 1.00 | 4.5mg/dL | 0.997 | 0.993 |

Y= A-CHECK DS-A Blood Glucose Meter X= YSI 2300

Keiichi Ito

Dr. Jen, Ke-Min official correspondent for ALLIANCE International Co., Ltd.

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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 eagle or bird-like symbol with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all caps and appears to be in a sans-serif font.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

Alliance International Co., Ltd. c/o Dr. Ke-Min Jen No. 58, Fu Chiun Street Hsin Chu City, 30067, Taiwan, ROC

DEC - 7 2009

Re: k082965

Trade/Device Name: DS-A Blood Glucose Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose Test System Regulatory Class: II Product Code: CGA, NBW, JJX Dated: November 20, 2009 Received: December 01, 2009

Dear Dr. Jen:

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 class II (Special Controls), 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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# Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Signature

Courtney C. Harper, 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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# Indication for Use

510(k) Number (if known): (k)082965

# Device Name: DS-A Blood Glucose Monitoring System

Indication For Use:

The A-CHECK DS-A Blood Glucose Monitoring System is used with DS-A Test Strips and 3-level Controls for the measurement of glucose in fresh capillary whole blood from the finger. Testing is done outside the body ( in vitro diagnostic use). It is indicated for use at home ( over the counter [OTC] ) by person with diabetes, or in clinical setting by health care professionals, as an aid to monitor the effectiveness of diabetes control. These are not intended for the diagnosis of or screening for diabetes mellitus, and are not intended for use on neonates.

The DS-A Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. DS-A Test Strips must be used with the A-CHECK DS-A Blood Glucose Monitoring System. Testing is done outside the body (In Vitro diagnostic use). Thev 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. These are not intended for the diagnosis of or screening for diabetes mellitus, and are not intended for use on neonates.

The Alliance Blood Glucose 3 levels Control Solution are for use with the A-CHECK DS-A Blood Glucose Monitoring System and DS-A Test Strips as a quality control check to verify the accuracy of blood glucose test results.

Prescription Use (21 CFR Part 801 Subpart D) And / Or

Over the Counter Use _ V (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Carol Benson

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) (k)082965