GLUCOSE SHEPHERD BLOOD GLUCOSE MONITORING SYSTEM

K102316 · Broadmaster Biotech Corporation · CGA · Oct 7, 2011 · Clinical Chemistry

Device Facts

• Record ID: K102316
• Device Name: GLUCOSE SHEPHERD BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Broadmaster Biotech Corporation
• Product Code: CGA · Clinical Chemistry
• Decision Date: Oct 7, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Glucose Shepherd Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use) at home. It is used for quantitative measurement of glucose level in fresh capillary whole blood samples (from the finger, the palm, the forearm, the upper arm, the calf and the thigh). The alternative site testing can be only used during steady-state blood glucose monitoring. The Glucose Shepherd Blood Glucose Monitoring System is intended for use by a single person and should not be shared. In addition, it is intended for use at home as an aid in monitoring the effectiveness of diabetes control program. It should not be used for the diagnosis or screening of diabetes, nor for the testing of neonates. The Glucose Shepherd Pro Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use). It is used for quantitative measurement of glucose level in fresh capillary whole blood samples (from the finger, the palm, the forearm, the upper arm, the calf and the thigh). The alternative site testing can be only used during steady-state blood glucose monitoring. The Glucose Shepherd Pro Blood Glucose Monitoring System may be used for multiple patients in a professional healthcare setting. It is intended for use as an aid in monitoring the effectiveness of diabetes control program. This system is only used with single-use, auto-disabling lancing devices. It should not be used for the diagnosis or screening of diabetes, for the testing of neonates, or for testing of arterial blood.

Device Story

System measures glucose in capillary whole blood via amperometric electrochemical method; glucose oxidase enzyme on test strip reacts with sample to produce electrical current proportional to glucose concentration. Meter measures current and ambient temperature to calculate glucose level. Used at home (single-patient) or professional settings (multi-patient). Requires 1.1 μL blood sample; results displayed in 5 seconds. Pro version requires single-use, auto-disabling lancing devices and disinfection between patients. Data can be linked to PC. Aids clinicians and patients in monitoring diabetes control effectiveness; not for diagnosis or screening. Benefits include rapid, quantitative glucose monitoring at various body sites during steady-state conditions.

Clinical Evidence

No clinical trials; performance established via bench testing and method comparison studies. Accuracy evaluated against YSI 2300 reference method using 114 patients (venous) and 99 patients (fingerstick/AST). Results met ISO 15197 criteria: 95% of results <75 mg/dL within ±15 mg/dL and ≥75 mg/dL within ±20% of reference. Precision studies (repeatability/intermediate) showed CVs <5%. Interference testing evaluated 18 substances; significant interference noted for acetaminophen, dopamine, levo-dopa, tolbutamide, gentisic acid, tolazamide, ascorbic acid, uric acid, ibuprofen, and mannose.

Technological Characteristics

Amperometric sensing using glucose oxidase enzyme. Power: two 1.5V AAA alkaline batteries. Hematocrit range: 20-60%. Operating conditions: 10°C-40°C, <85% R.H. Connectivity: PC link. Form factor: handheld meter.

Indications for Use

Indicated for quantitative measurement of glucose in fresh capillary whole blood (finger, palm, forearm, upper arm, calf, thigh) to monitor diabetes control effectiveness. Contraindicated for neonates, diabetes diagnosis/screening, and arterial blood testing. Pro version indicated for professional healthcare settings (multiple patients) using auto-disabling lancing devices.

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

• Advocate Redi-Code Blood Glucose Monitoring System (k072039)

Submission Summary (Full Text)

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510k Summary for A.) Glucose Shepherd Blood Glucose Monitoring System and B.) Glucose Shepherd Pro Blood Glucose Monitoring System

OCT - 7 2011

# 510(k) Summary (Per 21 CFR 807.92)

| | 1. Submitter Information | |
|--|--------------------------|------------------------------------------------------------------------------------------------------------------------------|
| | Company Name | BroadMaster Biotech Corporation |
| | Address | 7F, No. 168-2, Liancheng Rd., Zhonghe City<br>Taipei County 23553, Taiwan |
| | Contact Person | Roger Lai |
| | Phone | 886-987-111105/886-2-66375859 |
| | Fax | 886-2-22428332 |
| | Email | [e-mail] |
| | Date Prepared | 2010/8/13 |
| | 2. Device Name | |
| | Proprietary Name | A.)Glucose Shepherd Blood Glucose<br>Monitoring System<br>and<br>B.) Glucose Shepherd Pro Blood Glucose<br>Monitoring System |
| | Common Name | Blood Glucose Test System |
| | Classification Number | System, Test, Blood Glucose, Over the<br>Counter |
| | Classification Panel | Chemistry |
| | Product Code | NBW, CGA |
| | Regulation Number | 862.1345 |
| | 3. Predicate Device | |
| | Proprietary Name | Advocate Redi-Code Blood Glucose<br>Monitoring System |
| | Common Name | Blood Glucose Test System |
| | Manufacturer | Taidoc Technology Corporation |
| | 510(k) Number | k072039 |

## 4. Device Description

A.) Glucose Shepherd Blood Glucose Monitoring System consists of a

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blood glucose meter, test strips, control solutions(Level 1, 2 and 3), lancing device, and commercially available sterilized lancets. This system utilizes amperometric method to generate a current. The size of the current is proportional to the amount of glucose presented in the sample, providing a quantitative measure of glucose level in whole blood.

B.) Glucose Shepherd Pro Blood Glucose Monitoring System consists of a blood glucose meter, test strips, control solutions(Level 1, 2 and 3) and single-use lancing devices. This system utilizes amperometric method to generate a current. The size of the current is proportional to the amount of glucose level presented in the sample, providing a quantitative measure of glucose level in whole blood.

#### Intended Use

A.) Glucose Shepherd Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use) at home. It is used for quantitative measurement of glucose level in fresh capillary whole blood samples (from the finger, the palm, the forearm, the upper arm, the calf and the thigh). The alternative site testing can be only used during steady-state blood glucose monitoring. The Glucose Shepherd Blood Glucose Monitoring System is intended for use by a single person and should not be shared. In addition, it is intended for use at home as an aid in monitoring the effectiveness of diabetes control program. It should not be used for the diagnosis or screening of diabetes, nor for the testing of neonates.

The Glucose Shepherd Blood Glucose Monitoring System consists of the Glucose Shepherd Blood Glucose meter and the Glucose Shepherd Blood Glucose test strips. The Glucose Shepherd Blood Glucose meter is used only with Glucose Shepherd Blood Glucose test strips to quantitatively measure glucose in fresh capillary whole blood samples drawn from finger tips, the palm, the forearm, the upper arm, the calf and the thigh.

The Glucose Shepherd Control Solutions are for use with the Glucose Shepherd Blood Glucose Monitoring System as a quality control check to verify the accuracy of blood glucose test results.

B.) Glucose Shepherd Pro Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use). It is used for quantitative measurement of glucose level in fresh capillary whole blood samples (from the

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finger, the palm, the forearm, the upper arm, the calf and the thigh). The alternative site testing can be only used during steady-state blood glucose monitoring. The Glucose Shepherd Pro Blood Glucose Monitoring System may be used for multiple patients in a professional healthcare setting. I is intended for use as an aid in monitoring the effectiveness of diabetes control program. This system is only used with single-use, auto-disabling lancing devices. It should not be used for the diagnosis or screening of diabetes, for the testing of neonates, or for testing of arterial blood.

The Glucose Shepherd Pro Blood Glucose Monitoring System consists of the Glucose Shepherd Pro Blood Glucose meter and the Glucose Shepherd Pro Blood Glucose test strips. The Glucose Shepherd Pro Blood Glucose meter is used only with Glucose Shepherd Pro Blood Glucose test strips to quantitatively measure glucose in fresh capillary whole blood samples drawn from finger tips, the palm, the forearm, the upper arm, the calf and the thigh.

The Glucose Shepherd Pro control solutions are for use with the Glucose Shepherd Pro Blood Glucose Monitoring System as a quality control check to verify the accuracy of blood glucose test results.

| Similarities | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | Glucose Shepherd Blood<br>Glucose Monitoring System<br>(Proposed device) | Advocate Redi-Code Blood<br>Glucose Monitoring System<br>(Predicate device) |
| Enzyme | Glucose Oxidase | Same |
| Measurement<br>principle | Amperometric method | Same |
| Intended use | Glucose Shepherd Blood<br>Glucose Monitoring System is<br>intended for use outside the<br>body (in vitro diagnostic use) at<br>home. It is used for<br>quantitative measurement of<br>glucose level in fresh capillary<br>whole blood samples (from the | The Advocate Redi-Code<br>Blood Glucose Monitoring<br>System is intended for use in<br>the quantitative measurement<br>of glucose in fresh capillary<br>whole blood from the finger<br>and the following alternative<br>sites: the palm, the forearm, |
| finger, the palm, the forearm, the upper arm, the calf and the thigh). The alternative site testing can be only used during steady-state blood glucose monitoring. The Glucose Shepherd Blood Glucose Monitoring System is intended for use by a single person and should not be shared. In addition, it is intended for use at home as an aid in monitoring the effectiveness of diabetes control program. It should not be used for the diagnosis or screening of diabetes, nor for the testing of neonates. | the upper-arm, the calf and the thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. | |
| The Glucose Shepherd Blood Glucose Monitoring System consists of the Glucose Shepherd Blood Glucose meter and the Glucose Shepherd Blood Glucose test strips. The Glucose Shepherd Blood Glucose meter is used only with Glucose Shepherd Blood Glucose test strips to quantitatively measure glucose in fresh capillary whole blood samples drawn from finger tips, the palm, the forearm, the upper arm, the calf and the thigh. | | |
| The Glucose Shepherd Control Solutions are for use with the | | |
| Glucose Shepherd Blood<br>Glucose Monitoring System as<br>a quality control check to verify<br>the accuracy of blood glucose<br>test results. | | |
| Sample type | Fresh capillary whole blood | Same |
| Coding | No | Same |
| Power | Two 1.5V AAA alkaline<br>batteries | Same |
| Alternate site<br>capability | Yes | Same |
| Hematocrit<br>range | 20-60% | Same |
| Operating<br>condition | 50°F ~ 104°F (10°C ~ 40°C),<br>below 85% R.H. | Same |
| Strip storage<br>condition | 39.2°F ~ 104°F (4°C ~ 40°C),<br>below 85% R.H. | Same |
| PC link | Yes | Same |
| Differences | | |
| Weight | 53g | 69.87g |
| Dimensions | 64mmx95mmx29mm | 96mm(L)x20mm(W)x45mm(H) |
| Test time | 5 seconds | 7 seconds |
| Test volume | 1.1µL | 0.7µL |
| Memory | 400 measurements with<br>optional before/after meal flags | 450 measurements with day<br>and time |
| Test Range | 20-600 mg/dL | 20-600 mg/dL |
| Glucose<br>units | mg/dL | Either mg/dL or mmol/L |
| Alarms | 6 | No |
| Pre-meal and<br>Post-meal<br>flags | Yes | No |
| B.) | | |
| Similarities | | |
| Item | Glucose Shepherd Pro Blood | Advocate Redi-Code Blood |

### 5. Comparison to Predicate Device

A.)

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| Similarities | | |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | Glucose Shepherd Pro Blood | Advocate Redi-Code Blood |
| | Glucose Monitoring System<br>(Proposed device) | Glucose Monitoring System<br>(Predicate device) |
| Enzyme | Glucose Oxidase | Same |
| Measurement<br>principle | Amperometric method | Same |
| Intended use | Glucose Shepherd Pro Blood<br>Glucose Monitoring System is<br>intended for use outside the<br>body (in vitro diagnostic<br>use). It is used for quantitative<br>measurement of glucose level<br>in fresh capillary whole blood<br>samples (from the finger, the<br>palm, the forearm, the upper<br>arm, the calf and the<br>thigh). The alternative site<br>testing can be only used during<br>steady-state blood glucose<br>monitoring. The Glucose<br>Shepherd Pro Blood Glucose<br>Monitoring System may be<br>used for multiple patients in a<br>professional healthcare<br>setting. It is intended for use<br>as an aid in monitoring the<br>effectiveness of diabetes<br>control program. This system<br>is only used with single-use,<br>auto-disabling lancing<br>devices. It should not be used<br>for the diagnosis or screening<br>of diabetes, for the testing of<br>neonates, or for testing of<br>arterial blood.<br><br>The Glucose Shepherd Pro<br>Blood Glucose Monitoring<br>System consists of the | The Advocate Redi-Code<br>Blood Glucose Monitoring<br>System is intended for use in<br>the quantitative measurement<br>of glucose in fresh capillary<br>whole blood from the finger<br>and the following alternative<br>sites: the palm, the forearm,<br>the upper-arm, the calf and the<br>thigh. It is intended for use by<br>healthcare professionals and<br>people with diabetes mellitus at<br>home as an aid in monitoring<br>the effectiveness of diabetes<br>control program. It is not<br>intended for the diagnosis of or<br>screening for diabetes mellitus,<br>and is not intended for use on<br>neonates. |
| Weight | 53g | 69.87g |
| Differences | | |
| PC link | Yes | Same |
| condition | below 85% R.H. | |
| Strip storage | 39.2°F ~ 104°F (4°C ~ 40°C), | Same |
| condition | below 85% R.H. | |
| Operating | 50°F ~ 104°F (10°C ~ 40°C), | Same |
| range | | |
| Hematocrit | 20-60% | Same |
| capability | | |
| Alternate site | Yes | Same |
| | batteries | |
| Power | Two 1.5V AAA alkaline | Same |
| Coding | No | Same |
| Sample type | Fresh capillary whole blood | Same |
| | blood glucose test results. | |
| | check to verify the accuracy of | |
| | System as a quality control…