U-RIGHT TD-4227 NO CODING BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4222

K090188 · Taidoc Technology Corporation · NBW · Jul 13, 2009 · Clinical Chemistry

Device Facts

• Record ID: K090188
• Device Name: U-RIGHT TD-4227 NO CODING BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4222
• Applicant: Taidoc Technology Corporation
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jul 13, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

U-RIGHT TD-4227 No Coding Blood Glucose Monitoring System is indicated for the quantitative measurement of glucose in fresh capillary whole blood taken from the finger and the alternative sites for self testing by persons with diabetes in the home or by healthcare professionals in healthcare facilities. Testing is done outside the body (in vitro diagnostic use). The alternative site testing (the plam, the forearm, the upper arm, the calf and the thigh) in this system can be used only during steady-state blood glucose conditions. This system contains speaker function which provides step by step instructions.

Device Story

System comprises blood glucose meter and dry reagent biosensor test strips; utilizes electrochemical method. Input: fresh capillary whole blood or control solution. Operation: current generated in test strip proportional to glucose concentration; meter quantifies glucose level. Output: quantitative glucose measurement displayed to user; integrated speaker provides step-by-step audio instructions for visually impaired users. Used in home or clinical settings by patients or healthcare professionals. Output informs diabetes management and monitoring of control program effectiveness.

Clinical Evidence

No new clinical data provided. Performance characteristics, including precision, reproducibility, linearity, detection limit, and analytical specificity, were established in previously cleared submissions (k062235 and k072784).

Technological Characteristics

Electrochemical biosensor system. Quantitative measurement of glucose via current proportional to sample glucose concentration. Includes integrated speaker for audio instructions. Standalone meter device.

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood (finger, palm, forearm, upper-arm, calf, thigh) for diabetes mellitus patients at home or healthcare professionals. Not for neonates, diagnosis, or screening. Alternative site testing restricted to steady-state conditions.

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

• Prodigy Autocode Blood Glucose Monitoring System (k072784)
• Clever Chek TD-4227 Blood Glucose Monitoring System (k072784)

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY AND INSTRUMENT COMBINATION TEMPLATE

A. 510(k) Number:
k090188

B. Purpose for Submission:
New device

C. Measurand:
Whole blood glucose

D. Type of Test:
Quantitative amperometric assay (glucose oxidase)

E. Applicant:
TaiDoc Technology Corporation

F. Proprietary and Established Names:
U-RIGHT TD-4227 No Coding Blood Glucose Monitoring System

G. Regulatory Information:
1. Regulation section:
21 CFR § 862.1345, Glucose Test System
2. Classification:
Class II
3. Product code:
NBW, CGA
4. Panel:
75 (Clinical Chemistry)

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H. Intended Use:

1. Intended use(s):

Refer to indications for use below.

2. Indication(s) for use:

The U-RIGHT TD-4227 No Coding Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, 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 also includes a speaking functionality to aid visually impaired persons. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

The alternative site testing in the U-RIGHT TD-4227 No Coding Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.

This system contains a speaking functionality which provides step by step instructions to aid visually impaired persons.

3. Special conditions for use statement(s):

This device is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. The device should not be used for patients who are dehydrated, in shock, critically ill or in a hyperosmolar state. For in vitro diagnostic use only. This device may be used over the counter and by health care professionals.

4. Special instrument requirements:

U-RIGHT TD-4227 No Coding Blood Glucose Monitoring System

I. Device Description:

This glucose meter was previously cleared under k072784 as the TaiDoc Prodigy Autocode Blood Glucose Monitoring System and the TaiDoc Clever Chek TD-4227 Blood Glucose Monitoring System. The predicate for k072784 was k062235, also from TaiDoc, and performance data from k062235 was used to support the clearance of k072784.

The new device in this submission is the same as the one reviewed in k072784 except for the brand name.

J. Substantial Equivalence Information:

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1. Predicate device name(s):

Prodigy Autocode Blood Glucose Monitoring System
Clever Chek TD-4227 Blood Glucose Monitoring System

2. Predicate 510(k) number(s):

k072784

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Alternate sampling sites | Same | Palm, forearm, upper arm, calf, thigh |
| Methodology | Same | Quantitative, amperometric, using glucose oxidase |
| Sample size | Same | 0.7 μL |
| Reaction time | Same | 7 seconds |
| Measuring range | Same | 20 – 600 mg/dL |
| Environmental conditions | Same | 10 – 40°C
Below 85% relative humidity |
| Memory capacity | Same | 450 measurements with date and time |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Device Name | U-RIGHT TD-4227 No Coding Blood Glucose Monitoring System | Clever Chek TD-4227 Blood Glucose Monitoring System, Prodigy Autocode Blood Glucose Monitoring System |

# K. Standard/Guidance Document Referenced (if applicable):

None were referenced.

# L. Test Principle:

To perform a test, the test strip is inserted into the monitor. A drop of blood is applied to the end of the strip and automatically drawn into the sample chamber. Glucose measurement is based on electrical current caused by the reaction of glucose with the reagents contained on

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the strip's electrodes. The current resulting from this enzymatic reaction is proportional to the glucose concentration in the sample.

## M. Performance Characteristics (if/when applicable):

1. **Analytical performance:**

a. **Precision/Reproducibility:**
Precision and reproducibility were evaluated in k062235.

b. **Linearity/assay reportable range:**
Linearity was evaluated in k062235.

c. **Traceability, Stability, Expected values (controls, calibrators, or methods):**
The controls supplied with this device were cleared under k072784.

d. **Detection limit:**
The detection limit of the U-RIGHT TD-4227 No Coding Blood Glucose Monitoring System is 20 mg/dL, and was evaluated in k062235.

e. **Analytical specificity:**
Specificity was evaluated in k062235.

f. **Assay cut-off:**
Not applicable

2. **Comparison studies:**

a. **Method comparison with predicate device:**
Method comparison studies were evaluated in k072784.

b. **Matrix comparison:**
Not applicable – capillary whole blood is the only matrix that has been validated with this device.

3. **Clinical studies:**

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a. Clinical Sensitivity:

Not applicable

b. Clinical specificity:

Not applicable

c. Other clinical supportive data (when a. and b. are not applicable):

4. Clinical cut-off:

Not applicable

5. Expected values/Reference range:

The sponsor includes the following Expected Values for people without diabetes in their glucose strip labeling:

| Status | Range |
| --- | --- |
| Fasting and before meals^{1} | 70-110 (mg/dL) (3.9-6.1 mmol/L) |
| 2 hours after meals^{2} | Less than 140 mg/dl (7.8 mmol/L) |

Sources:

1. Tietz Textbook of Clinical Chemistry, 1999
2. American Diabetes Association Clinical Practice Recommendations, 2003

N. Instrument Name:

U-RIGHT TD-4227 No Coding Blood Glucose meter.

O. System Descriptions:

1. Modes of Operation:

Each test strip is single use and must be replaced with a new strip for additional readings.

2. Software:

FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types: Yes ☐ X ☑ or No ☐

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3. Specimen Identification:

There is no sample identification function with this device. Samples are applied directly to the test strip as they are collected.

4. Specimen Sampling and Handling:

This device is intended to be used with capillary whole blood from the fingertip, palm, forearm, upper-arm, calf and thigh. Since the whole blood sample is applied directly to the test strip there are no special handling or storage issues.

5. Calibration:

Calibration is factory set by the manufacturer. No coding by the user is required.

6. Quality Control:

The sponsor provides one level of Control Solution. The other two levels of control may be purchased separately. To perform a control test the user is instructed to press the M button after the blood drop has appeared on the display. This prevents control results from being stored in the internal memory. The acceptable range for each level is printed on the test strip vial label. If control results fall outside these ranges, the user is referred to a list of troubleshooting steps and the customer care line.

P. Other Supportive Instrument Performance Characteristics Data Not Covered In The "Performance Characteristics" Section above:

Q. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

R. Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.