RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM

K062567 · Bionime Corporation · NBW · Feb 16, 2007 · Clinical Chemistry

Device Facts

• Record ID: K062567
• Device Name: RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Bionime Corporation
• Product Code: NBW · Clinical Chemistry
• Decision Date: Feb 16, 2007
• 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. Special conditions for use statement(s): Rightest System provides plasma equivalent results.

Device Story

System measures glucose in fresh capillary whole blood; utilizes meter, test strips, code key, check key, and control solutions. Principle: glucose oxidase/potassium ferricyanide reaction on strip produces electrical current proportional to glucose concentration; meter converts current to glucose value. Used by patients at home or professionals in clinics. User applies blood sample to strip; meter provides digital readout. Output aids diabetes management decisions. Modifications from predicate include reduced sample volume (1.4 µL), faster test time (8s), and increased memory (300 tests).

Clinical Evidence

Clinical study with 176 lay-users and technicians compared fingertip, palm, and forearm capillary samples against YSI laboratory reference. Samples ranged 30-572 mg/dL. System accuracy: 96-100% of samples <75 mg/dL were within ±15 mg/dL of YSI; 96-98% of samples ≥75 mg/dL were within ±20% of YSI. Additional 40-patient study confirmed performance. Bench testing included precision (CV 1.95-3.76%) and linearity (R²=0.999).

Technological Characteristics

Quantitative amperometric assay using glucose oxidase and potassium ferricyanide. Meter-based system with disposable test strips. Sample volume 1.4 µL; test time 8 seconds. Reportable range 20-600 mg/dL. Calibration via Smart Code Key. Connectivity: internal memory for 300 tests. Standards: CLSI EP5-A, EP6-A, EP7-A, EP9-A2; EN 60601-1-2 (EMC).

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 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)
• Rightest Blood Glucose Monitoring System (k053635)

Submission Summary (Full Text)

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K062567

# 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:

#### 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: December 18, 2006

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

- 3. Common or Usual Name: Glucose test system 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 consists of a Meter, Blood Glucose Test Strips, Code Key, Check key, Two Control Solutions, Lancing Device and lancets. The 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 the 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 used by professional healthcare personnel or people with diabetes at home to measure the glucose concentration for aiding diabetes management. The glucose concentration is measured with quantitative capillary whole blood from fingertip, palm and forearm 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.

Exhibit 1

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#### Predicate Device Information: 6.

1 1 1 1

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

Rightest Blood Glucose Monitoring System Name: Device Company: Bionime Corporation K042678 and K053635 510(K) Number:

### Comparison to Predicate Devices: 7.

| Similarities | | |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | Device<br>Rightest BGMS<br>(Alternative Site Testing) | Predicate<br>Rightest BGMS |
| Detection method | Amperometry | Amperometry |
| Enzyme | Glucose Oxidase<br>(Aspergillus niger) | Glucose Oxidase<br>(Aspergillus niger) |
| Mediator | Potassium ferricyanide | Potassium ferricyanide |
| 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 |
| Power | 1.5V×2 battery (LR03) | 1.5V×2 battery (LR03) |
| Test range | 20 - 600 mg/dL | 20 - 600 mg/dL |
| Differences | | |
| Item | Device(Alternative Site<br>Testing) | Predicate |
| | Rightest BGMS (AST) | Rightest BGMS |
| Sample Source | The glucose concentration<br>is measured with<br>quantitative capillary whole<br>blood from the fingertip,<br>palm and forearm by using<br>Rightest Blood Glucose<br>Monitoring System. | The glucose concentration<br>is measured with<br>quantitative capillary whole<br>blood from the fingertip,<br>palm and forearm by using<br>Rightest Blood Glucose<br>Monitoring System. |
| Description and<br>Labelling | We mention the information<br>about modification in user's | We mention the information<br>in user's manual. |

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| | manual. We also show a<br>diagrammatic explanation<br>about alternative test sites in<br>user's manual. | |
|---------------------------------|---------------------------------------------------------------------------------------------------------|----------------------------------------------------------|
| Test Time | 8 seconds | 15 seconds |
| Sample Volume | 1.4 uL | 2 uL |
| Memory<br>capability | 1, 7, 14, 30 day average and<br>last 300 tests in the memory | 3, 7, 14 day average and last<br>200 tests in the memory |
| Battery life | Running 1,000 test | Running 1,500 test |
| The unit of<br>measurement data | Fix on mg/dL | Switch between mg/dL and mmol/L |

### Discussion of Non-Clinical Tests Performed for Determination of Substantial 8. 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, hematocrit and control solution.

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

The clinical test was designed in Alternative site testing study as below

Test capillary blood bv technician Study:

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

| Technician | Rightest fingerstick vs<br>YSI-Plasma | Rightest palmstick vs<br>YSI-Plasma | Rightest armstick vs<br>YSI-Plasma |
|-------------|---------------------------------------|-------------------------------------|------------------------------------|
| Test range | | 30 ~ 572 | |
| Test number | 176 | 176 | 174 |
| Slope | 0.99 | 1.01 | 0.99 |
| Intercept | 2.51 | 1.70 | 2.21 |
| r | 0.9901 | 0.9910 | 0.9882 |

## 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

| Patient | Rightest fingerstick vs<br>YSI-Plasma | Rightest palmstick vs<br>YSI-Plasma | Rightest armstick vs<br>YSI-Plasma |
|-------------|---------------------------------------|-------------------------------------|------------------------------------|
| Test range | | 30-572 | |
| Test number | 176 | 175 | 174 |

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| Slope | 1.03 | 1.02 | 1.02 |
|-----------|--------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Intercept | -0.25 | 1.19 | -0.84 |
| 1 | 0.9911 | 0.9912<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | 0.9906 |

The "Alternative Site Test" clinical evaluation shows substantial equivalence 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.

#### Conclusions: 10.

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 logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the body and wings. The symbol is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A." is written around the border.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

FEB 1 6 2007

Re: k062567

Trade/Device Name: Rightest Blood Glucose Monitoring System Regulation Number: 21 CFR § 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, CGA Dated: February 2, 2007 Received: February 5, 2007

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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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 at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Jean m. Cooper, M.S., D.V.M.

Yean M. Cooper, M.S., D.V.M. 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

k062567 510(k) Number (if known):_

#### Rightest Blood Glucose Monitoring System Device Name:

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

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

Over-The-Counter Use (21 CFR 807 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)

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