RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM

K042678 · Bionime Corporation · NBW · Jan 3, 2005 · Clinical Chemistry

Device Facts

• Record ID: K042678
• Device Name: RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Bionime Corporation
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jan 3, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Rightest Blood Glucose Monitoring System is intended for in vitro diagnostic use (outside of body). It is indicated to be used by professional healthcare personnel or diabetics at home to measure the glucose concentration for aiding diabetes management. The glucose concentration is measured with quantitative capillary whole blood from the fingertip by using Rightest Blood Glucose Monitoring System. This device is not intended for testing neonate blood samples. Special condition for use statement(s): Rightest System provides plasma equivalent results.

Device Story

System measures glucose concentration in capillary whole blood; utilizes amperometric assay with glucose oxidase and potassium ferricyanide. User inserts Smart Code Key (batch-specific calibration) and test strip into meter; applies blood drop to strip via capillary action. Meter measures electrical current proportional to glucose; converts to concentration; displays result; stores in memory. Used by patients at home or professionals in clinical settings. Check key enables control mode for quality assurance using control solutions. Provides quantitative glucose readings to aid diabetes management.

Clinical Evidence

Clinical evidence includes a consumer study (n=128) and a point-of-care study (n=309). Consumer study showed linear regression between lay users and technicians (R=0.9959, slope=1.0066). Point-of-care study compared device to YSI 2300D analyzer across capillary whole blood, venous whole blood, and venous plasma. Results showed high correlation (R=0.9886 for capillary, R=0.9873 for venous whole blood, R=0.9980 for venous plasma).

Technological Characteristics

Amperometric glucose monitoring system. Uses noble metal electrodes, glucose oxidase enzyme, and potassium ferricyanide mediator. Reportable range 20-600 mg/dL. Calibration via batch-specific Smart Code Key. Operates on capillary whole blood. Includes meter, test strips, control solutions, check key, and lancets. Software hazard analysis performed.

Indications for Use

Indicated for professional healthcare personnel or diabetics at home to measure glucose concentration in capillary whole blood from the fingertip for diabetes management. Not for use with neonate blood samples.

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

• ONE TOUCH® Ultra® Blood Glucose Monitoring System (K024194)

Submission Summary (Full Text)

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### EXHIBIT #1

## 510(K) SUMMARY

This summary of 5l0(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is:_ 1042678

#### Submitter's Identification: 1.

BIONIME CORPORATION NO 694, RENHUA ROAD, DALI CITY, TAICHUNG COUNTY, TAIWAN 412 Contact Person: Patrick Hsieh Phone Number: 886-4-24951268 FAX Number: 886-4-24952568

Date Summary Prepared: September 28, 2004.

#### Name of the Device: Rightest Blood Glucose Monitoring System 2.

- Common or Usual Name: Glucose test system 3. Panel: Clinical Chemistry 75 Product Code: NBW, System, Test, Blood Glucose, Over the Counter. Classification: Class II
#### 4. Device Description:

Our Blood Glucose Monitoring System includes Meter, Blood Glucose Test Strips, Code Kev. Check key, One Control Solution, Lancing Device and lancets. Rightest meter, Blood Glucose Test Strips, Code Key and Check key are manufactured by BIONIME Corporation. The Rightest Meter, when used with the Rightest Blood Glucose Test Strips, quantitatively measures glucose in fresh capillary whole blood.

The performance of the Rightest Blood Glucose Test Strips is verified by Control Solution. The Check key verifies the status of Rightest meter.

#### 5. Intended Use:

The Rightest Blood Glucose Monitoring System is intended for in vitro diagnostic use (outside of body). It is indicated to be used by professional healthcare personnel or diabetics at home to measure the glucose concentration for aiding diabetes management. The glucose concentration is measured with quantitative capillary whole blood from the fingertip by using Rightest Blood Glucose Monitoring System.

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This device is not intended for testing neonate blood samples.

Special condition for use statement(s): Rightest System provides plasma equivalent results.

#### Predicate Device Information: 6.

The Rightest Blood Glucose Monitoring System is substantially equivalent to the brand of ONE TOUCH Ultra noted below.

ONE TOUCH® Ultra® Blood Glucose Monitoring System Name: Device Company: Lifescan, Inc. 510(K) Number: K024194

#### Comparison to the Predicate Device: 7.

| Similarities | | |
|--------------------------|-------------------------------------------------------------|----------------------------------------------------|
| Item | Device<br>Rightest | Predicate<br>ONE TOUCH® Ultra® |
| Detection<br>method | Amperometry | Amperometry |
| Enzyme | Glucose Oxidase<br>(Aspergillus niger) | Glucose Oxidase<br>(Aspergillus niger) |
| Mediator | Potassium ferricyanide | Potassium ferricyanide |
| Test range | 20 - 600 mg/dL | 20 - 600 mg/ dL |
| Hematocrit<br>Range | 30 – 55% | 30 - 55% |
| Temperature<br>range | 50 - 104° F<br>10 - 40° C | 43 - 111° F<br>6 - 44° C |
| Humidity range | 10 - 90% | 10 - 90% |
| Warranty(meter) | 3 years | 3 years |
| Open use time<br>(strip) | 3 months | 3 months |
| Differences | | |
| Item | Device<br>Rightest | Predicate<br>ONE TOUCH® ULTRA® |
| Electrode | Noble metal electrode | Carbon electrode |
| Coding | Code key | Button (C1 - C49) |
| Test Time | 15 seconds | 5 seconds |
| Sample Volume | 2 uL | 1 uL |
| Memory<br>capability | 3, 7, 14 day average and<br>last 200 tests in the<br>memory | 14-day average and last<br>150 tests in the memory |
| Power | $1.5V\times2$ battery (LR03) | 3V Li battery (CR2032) |
| Battery life | Running 1,500 test | Running 1,000 test |
| Size: LxWxH | 85.0x58.0x22.5 | 79x57x21 |

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| (mm) | | |
|--------|--------------------|--------------------|
| Weight | 85g (with battery) | 42g (with battery) |

### Discussion of Non-Clinical Tests Performed for Determination of 8. Substantial Equivalence are as follows:

Verification and validation of test results were evaluated to establish the verformance, functionality and reliability of The Rightest Blood Glucose Monitoring System. Testing included precision testing, linearity testing, sensitivity testing, interference testing, stability testing and electrical/EMC testing.

#### Discussion of Clinical Tests Performed: 9.

Clinical testing included a consumer study and point of care study as outlined below:

### Consumer Study (field test):

Linear regression was established between lay user (Y axial) and technician (X axial).

| Blood type | Capillary whole blood |
|----------------|-----------------------|
| Patient number | 128 |
| Testing range | 56.0~556 mg/dL |
| Slope | 1.0066 |
| Intercept | -0.576 |
| R | 0.9959 |

### Point Of Care Study:

I officer correlation between the YSI 2300D glucose analyzer (X axial) and Rightest Blood Glucose Monitoring System (Y axial) were confirmed in the 309 blood samples. Results obtained by 3 positions in the same general hospital presented the following regression:

| Blood type | Capillary Whole<br>Blood | Venous Whole<br>Blood | Venous Plasma |
|----------------|--------------------------|-----------------------|---------------|
| Patient number | | 309 | |
| Testing range | | 68.0 ~ 565 mg/dL | |
| Slope | 1.0025 | 1.1806 | 1.819 |
| Intercept | 4.509 | -1.362 | 2.280 |
| R | 0.9886 | 0.9873 | 0.9980 |

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#### 10. Conclusions:

Results of evaluation and clinical testing demonstrate that the performance of the Rightest Blood Glucose Monitoring System testing capillary whole blood is substantially equivalent to the predicate device, ONE TOUCH® Ultra® Blood Glucose Monitoring System. The precision and accuracy of Rightest is suitable for its use in monitoring the effectiveness of diabetes management at home and in clinical settings.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services-USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or other bird in flight. The symbol is composed of three curved lines that suggest the wings and body of the bird.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN - 3 2005

Bionime Corporation c/o Ms. Susan D. Goldstein-Falk Official Correspondent MDI Consultant, Inc. 55 Northern Blvd. Suite 200 Great Neck, NY 11021

k042678 Re:

Trade/Device Name: Rightest Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA, JJX Dated: December 17, 2004 Received: December 20, 2004

Dear Ms. Goldstein-Falk:

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours.

Patricia Bernhart
for C. Rooks

Cornelia B. Rooks, MA Acting 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):

Device Name: Rightest Blood Glucose Monitoring System

Indications For Use:

The Rightest Blood Glucose Monitoring System is intended for in vitro diagnostic use (outside of body). It is indicated to be used by professional healthcare personnel or diabetics at home to measure the glucose concentration for aiding diabetes management. The glucose concentration is measured using capillary whole blood from the fingertip by using Rightest Blood Glucose Monitoring System.

This test device is not intended for testing neonate blood samples.

Special condition for use statement(s): Rightest System provides plasma equivalent results.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use x (21 CFR 807 Subpart C)

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

Division Signer of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Office of In Vitro Diagnostic Device Evaluation and Safety

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510(k) K042678