RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM110

K081450 · Bionime Corporation · NBW · Sep 11, 2008 · Clinical Chemistry

Device Facts

• Record ID: K081450
• Device Name: RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM110
• Applicant: Bionime Corporation
• Product Code: NBW · Clinical Chemistry
• Decision Date: Sep 11, 2008
• Decision: SESE
• Submission Type: Special
• 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

Rightest Blood Glucose Monitoring System (GM110) measures glucose concentration in fresh capillary whole blood; utilizes meter, test strips, control solutions, and lancing device. Principle of operation: amperometry using glucose oxidase (Aspergillus niger) and potassium ferricyanide mediator on noble metal electrodes. User applies blood sample (1.4 uL) to test strip; meter provides quantitative result in 8 seconds. Used by patients at home or healthcare professionals in clinical settings. Output displayed on meter; aids diabetes management decisions. System provides plasma-equivalent results.

Clinical Evidence

Clinical study evaluated alternative site testing (fingertip, palm, forearm) against Olympus AU2700 plasma reference. Sample size: 164 tests per site. Results showed high correlation (r=0.990 to 0.991) and similar slopes (0.95-0.98) and intercepts (2.13-9.80) across all sites. Bench testing confirmed precision, linearity, interference, and hematocrit range (30-55%).

Technological Characteristics

Electrochemical blood glucose meter; manual coding mechanism; mechanical housing; internal memory storage. Fundamental scientific technology consistent with predicate device.

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. Contraindicated 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)
• Rightest Blood Glucose Monitoring System (K062567)

Submission Summary (Full Text)

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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: 881450

- 1. Submitter's Identification:
BIONIME CORPORRATION NO 694, RENHUA ROAD, DALI CITY, TAICHUNG COUNTY, TAIWAN 412 Contact Person: Mr. George Chi Phone Number: 886-4-24951268 FAX Number: 886-4-24952568

Date Summary Prepared: July 13, 2007

- Name of the Device: Rightest Blood Glucose Monitoring System, Model GM110 2.
- 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, Two Control Solutions, Lancing Device and lancets. The Rightest Meter, Blood Glucose Test Strips are manufactured by BIONIME Corporation. The Rightest Meter, when used with the Rightest Test Strips, quantitatively measures glucose in fresh capillary whole blood. The performance of the Rightest Blood Glucose Monitoring System is verified by the Control Solution.

- 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 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.

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

- 6. Predicate Device Information:
The Rightest Blood Glucose Monitoring System, model GM110 is substantially equivalent to the brand of Rightest Blood Glucose Monitoring System (Alternative Site Testing) noted below.

Rightest Blood Glucose Monitoring System, model GM110 Name: Device Company: Bionime Corporation 510(K) Number: K042678, K053635 and K062567

| Comparison to Predicate Devices: | НИНИЕ В А ПРИВИНИЯ НА ВИНИНИИ В МИНИНИИ В ИНИНИНИЕ В НАС ПРОДОДЕЛА НА СЕДА С | |
|----------------------------------|------------------------------------------------------------------------------|--------------------------------------|
| | | Comments of the American Comments of |

| Similarities | | |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | Subject Device | Predicate Device(s) |
| | Rightest BGMS GM110<br>(Alternative Site Testing) | Rightest BGMS<br>(Alternative Site Testing) |
| Detection method | Amperometry | Amperometry |
| Enzyme | Glucose Oxidase<br>(Aspergillus niger) | Glucose Oxidase<br>(Aspergillus niger) |
| Mediator | Potassium ferricyanide | Potassium ferricyanide |
| Hematocrit Range | 30 - 55% | 30 - 55% |
| Temperature 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 |
| Test range | 20 - 600 mg/dL | 20 - 600 mg/dL |
| Test Time | 8 seconds | 8 seconds |
| Sample Volume | 1.4 uL | 1.4 uL |
| Sample Source | The glucose<br>concentration is<br>measured with<br>quantitative capillary<br>whole blood from the<br>fingertip, palm and<br>forearm by using Rightest<br>Blood Glucose<br>Monitoring System. | The glucose<br>concentration is<br>measured with<br>quantitative capillary<br>whole blood from the<br>fingertip, palm and<br>forearm by using Rightest<br>Blood Glucose<br>Monitoring System. |
| The unit of<br>measurement data | Fix on mg/dL | Fix on mg/dL |

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| Battery life | Running 1,000 test | Running 1,000 test |
|--------------|--------------------|--------------------|
| | | |

*

| Differences | | |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | Subject Device(s) | Predicate Device(s) |
| | Rightest BGMS GM110<br>(AST) | Rightest BGMS(AST) |
| Description and<br>Labelling | We mention the<br>information about<br>modification in user's<br>Instruction. We also show<br>a diagrammatic<br>explanation about<br>alternative test sites in<br>user's Instruction. | We mention the<br>information about<br>modification in user's<br>manual. We also show a<br>diagrammatic explanation<br>about alternative test sites<br>in user's manual. |
| Coding<br>Interference | Code Selection<br>Uric acid > 9.0 mg/dL<br>Cholesterol > 500 mg/dL | Code key<br>Uric acid > 9.0 mg/dL<br>L-Doga > 1.5 ml/dL<br>Methyldopa > 1.5 mg/dL<br>Cholesterol > 250 mg/dL |
| Memory Capacity | 10 blood glucose test<br>results with date and time | 300 blood glucose test<br>results with date and time |
| Power Saving | Turn off automatically after<br>2 minutes | Turn off automatically after<br>3 minutes |
| Power Supply | One CR2032 battery | Two 1.5V(AAA) batteries |

### 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 precision, linearity, interference, hematocrit and control solution.

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

Test capillary blood Study: It shows similarly slope and intercept for difference position of capillary blood test.

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| Technician | Rightest fingerstick vs<br>Olympus-Plasma | Rightest palmstick vs<br>Olympus-Plasma | Rightest armstick vs<br>Olympus-Plasma |
|--------------------|-------------------------------------------|-----------------------------------------|----------------------------------------|
| Test range (mg/dL) | 35~586 | 35~589 | 35~566 |
| Test number | 164 | 164 | 164 |
| Slope | 0.98 | 0.96 | 0.95 |
| Intercept | 2.13 | 9.80 | 2.82 |
| r | 0.991 | 0.990 | 0.990 |

## Fig 1 Linear regression from Rightest versus Olympus AU2700

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 Olympus AU2700. So the result tells us Rightest blood glucose monitoring system, model GM110 is suitable to be used in fingertip, palm and forearm.

#### 10. Conclusions:

Results of clinical testing demonstrate that the performance of the Rightest Blood Glucose Monitoring System, model GM110 testing capillary whole blood is substantial equivalence of Rightest Blood Glucose Monitoring System (AST). 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

DEPARTMENT OF HEALTH & HUMAN SERVICES - USA

Food and Druq Administration 2098 Gaither Road Rockville MD 20850

## SEP 1 1 2008

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

Rc: k081450

> Trade Name: Rightest Blood Glucose Monitoring System, Model GM110 Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Codes: NBW, CGA Dated: August 15, 2008 Received: August 18, 2008

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

510(k) Number (if known):

Device Name: Rightest Blood Glucose Monitoring System, Model GM110

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)

Carol C Benson
Division Sign-Off

Division Sign-O

Office of In Vitro Diagnostic Device Evaluation and Safety

K081450

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