MODIFICATION TO RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM

K053635 · Bionime Corporation · NBW · Feb 21, 2006 · Clinical Chemistry

Device Facts

• Record ID: K053635
• Device Name: MODIFICATION TO RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Bionime Corporation
• Product Code: NBW · Clinical Chemistry
• Decision Date: Feb 21, 2006
• 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, palm, and forearm by using Rightest Blood Glucose Monitoring System. This device is not intended for testing neonate blood samples.

Device Story

System measures glucose concentration in fresh capillary whole blood; samples applied to test strips. Principle: amperometric assay using glucose oxidase and potassium ferricyanide; electrical current proportional to glucose concentration measured by meter. Components: meter, test strips, code key, check key, control solutions, lancing device. Used by patients at home or healthcare professionals in clinical settings. Code key calibrates meter for specific strip batches. Output: quantitative glucose concentration displayed on meter; memory stores results for tracking. Enables diabetes management through self-monitoring or professional assessment. Alternate site testing (fingertip, palm, forearm) supported.

Clinical Evidence

Two method comparison studies conducted (technician-led and patient-led). Compared capillary blood from finger, palm, and forearm against YSI 2300D reference analyzer. Sample size: 132-134 per site. Results: Correlation coefficients (r) 0.9793-0.9874. Error Grid Analysis: 95.5-97.0% in Zone A, 3.0-4.5% in Zone B, 0% in Zone C. Bench testing confirmed precision, linearity (r²=0.9957), and analytical specificity.

Technological Characteristics

Amperometric glucose oxidase assay; noble metal electrode. Measures capillary whole blood (2 μL). Range: 20-600 mg/dL. Hematocrit range: 30-55%. Temperature: 10-40°C. Humidity: 10-90%. Power: 1.5V x 2 batteries. Calibration via Smart Code Key. Connectivity: internal memory for 200 tests. Software: embedded firmware.

Indications for Use

Indicated for professional healthcare personnel or diabetics at home to measure glucose concentration in capillary whole blood from fingertip, palm, or forearm 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

• Rightest Blood Glucose Monitoring System (K042678)

Submission Summary (Full Text)

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# FEB 2 1 2006

# Exhibit 1

# 510(K) SUMMARY

This summary of 510(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: K053635 .

#### 1. Submitter's Identification:

BIONIME CORPORRATION 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: February 2, 2006

- 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 Key, Check key, Two Control Solutions, 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 Test Strips 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, palm and forearm 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.

- Predicate Device Information: 6.

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

| Name: | Rightest Blood Glucose Monitoring System |
|-----------------|------------------------------------------|
| Device Company: | Bionime Corporation |
| 510(K) Number: | K042678 |

### 7. Comparison to Predicate Devices:

| Similarities | | |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Item | Device<br>Rightest(Alternative Site<br>Testing) | Predicate<br>Rightest |
| Detection 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 | 50 - 104° F<br>10 - 40° C |
| Humidity range | 10 - 90% | 10 - 90% |
| Warranty(meter) | 3 years | 3 years |
| Open use time<br>(strip) | 3 months | 3 months |
| Electrode | Noble metal electrode | Noble metal electrode |
| Coding | Code key | Code key |
| Test Time | 15 seconds | 15 seconds |
| Sample Volume | 2 uL | 2 uL |
| Memory<br>capability | 3, 7, 14 day average and last<br>200 tests in the memory | 3, 7, 14 day average and last<br>200 tests in the memory |
| Power | 1.5V×2 battery (LR03) | 1.5V×2 battery (LR03) |
| Battery life | Running 1,500 test | Running 1.500 test |
| Differences | | |
| Item | Device(Alternative Site<br>Testing) | Predicate |
| | Rightest | Rightest |
| Sample Source | The glucose<br>concentration is<br>measured with<br>quantitative capillary<br>whole blood from the<br>fingertip, palm and | The glucose<br>concentration is<br>measured with<br>quantitative capillary<br>whole blood from the<br>fingertip by using |

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| forearm by using Rightest<br>Blood Glucose<br>Monitoring System. | Rightest Blood Glucose<br>Monitoring System. | |
|------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|
| Description and<br>Labelling | We mention the<br>information about<br>alternative site testing in<br>user's manual and packing<br>box. We also show a<br>diagrammatic explanation<br>about alternative test sites<br>in user's manual. | We mention the<br>information in user's<br>manual. |

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

Verification and validation of test results were evaluated to establish the performance, functionality and reliability of The Rightest Blood Glucose Monitoring System.

The evaluation included with precision, linearity, interference, environment factors (ex. Temperature, humidity and altitude), hematocrit and control solution.

## 9. Discussion of Clinical Tests Performed: The clinical test was designed in Alternative site testing study as below

The clinical test was designed in Alternative site testing study as

Test capillary blood by technician Study:

It shows similarly slope and intercept for difference position of capillary blood test by technician.

| Technician | Rightest fingerstick<br>vs YSI-Plasma | Rightest palmstick<br>vs YSI-Plasma | Rightest armstick<br>vs YSI-Plasma |
|---------------|---------------------------------------|-------------------------------------|------------------------------------|
| Testing range | 55.7~490 mg/dL | 55.7~490 mg/dL | 55.7~490 mg/dL |
| Test number | 134 | 134 | 132 |
| Slope | 1.03 | 1.02 | 0.96 |
| Intercept | -1.63 | 1.18 | 6.55 |
| r | 0.9852 | 0.9862 | 0.9793 |

Fig 1 Linear regression from Rightest versus YSI 2300D

Test capillary blood by patient Study:

It shows similarly slope and intercept of difference positions of capillary blood test by Patient.

Fig 2 Linear regression from Rightest versus YSI 2300D

| Technician | Rightest fingerstick<br>vs YSI-Plasma | Rightest palmstick<br>vs YSI-Plasma | Rightest armstick<br>vs YSI-Plasma |
|---------------|---------------------------------------|-------------------------------------|------------------------------------|
| Testing range | | 55.7 ~ 490 mg/dL | |
| Test number | 134 | 133 | 132 |
| Slope | 1.06 | 1.03 | 0.99 |

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The "Alternative Site Test" clinical evaluation shows substantially equivalent to Rightest used in finger, palm and arm position. They all have similar slope and intercept of Rightest value versus YSI 2300D. So the result tells us Rightest blood glucose monitoring system is suitable to be used in finger, palm and arm.

### 10. Conclusions:

Results of clinical testing demonstrate that the performance of the Rightest Blood Glucose Monitoring System (Alternative Site Testing) testing capillary whole blood is substantial equivalence of Rightest Blood Glucose Monitoring System. The precision and accuracy of Rightest is suitable for its 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 U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, and three horizontal lines below the eagle. The text "U.S. Department of Health & Human Services - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 2 1 2006

Bionime Corporation c/o Ms. Susan D. Goldstein-Falk MDI Consultant, Inc. 55 Northern Blvd. Suite 200 Great Neck, NY 11201

Re: k053635

> 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 Dated: December 28, 2005 Received: December 29, 2005

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,

Alberto Gutierrez, Ph.D.

Alberto Gutierrez, 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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# Indications for Use

510(k) Number (if known): k053635

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 with quantitative capillary whole blood from the fingertip, palm and forearm 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.

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

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Ann Chappie

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Device I

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