RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM550

K092052 · Bionime Corporation · NBW · Jun 18, 2010 · Clinical Chemistry

Device Facts

• Record ID: K092052
• Device Name: RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM550
• Applicant: Bionime Corporation
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jun 18, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Rightest Blood Glucose Monitoring System, Model GM550 is intended for the quantitative measurement of glucose in capillary whole blood from the fingertip, palm and forearm by professional healthcare personnel in clinical settings or diabetics at home to measure the glucose concentration for aiding diabetes management. This device is not intended for testing neonate blood samples and is not intended for the diagnosis of or screening for diabetes mellitus. Rightest Blood Glucose Test Strips GS550 are intended for use with the Rightest GM550 Blood Glucose meter in the quantitative measurement of glucose in capillary whole blood from the fingertip, palm and forearm. Rightest Control Solutions are intended for use with the Rightest Blood Glucose Monitoring System, Model GM550 to check that both the glucose meters and test strips are working properly. These solutions contain a known range of glucose, as indicated on the bottles.

Device Story

System measures capillary whole blood glucose via electrochemical amperometric assay using glucose oxidase. User applies blood sample to test strip; meter detects current generated by glucose oxidation; current magnitude is proportional to glucose concentration. Device provides plasma-equivalent results. Used by healthcare professionals or patients at home for diabetes management. Features auto-coding, 500-test memory with averaging, and 5-second test time. Output displayed on meter screen; aids clinical decision-making for glycemic control. Benefits include rapid, quantitative glucose monitoring for diabetes management.

Clinical Evidence

Clinical study with 114 patients comparing subject device to Olympus 2700 lab reference method. Samples collected from fingertip, palm, and forearm. Results: 97% of test results within ±20% of reference at ≥75 mg/dL and within ±15 mg/dL at <75 mg/dL. User performance study confirmed lay consumers could obtain accurate results across all tested sites.

Technological Characteristics

Oxidase electrochemical sensor technology. Reagents: Glucose Oxidase, Potassium ferricyanide. Sample volume: 1.0 microliter. Test time: 5 seconds. Measurement range: 20-600 mg/dL. Power: 2x CR2032 batteries. Auto-coding. Memory: 500 results. Dimensions: 90.6 x 46 x 16.5 mm.

Indications for Use

Indicated for quantitative measurement of glucose in capillary whole blood (fingertip, palm, forearm) for diabetes management in professional clinical settings or home use by diabetics. Contraindicated for neonates, critically ill patients, patients in shock, dehydrated patients, or hyperosmolar patients. Not for screening or diagnosis of diabetes mellitus.

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, K053635 and K062567)

Submission Summary (Full Text)

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# JUN 1 8 2010

Exhibit 1

### 510(K) SUMMARY

This summary of 5/0(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: K09205 J

- 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: June 01, 2010

#### 2. Name of the Device: Rightest Blood Glucose Monitoring System, Model GM550

- 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
#### Device Description: 4.

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, and Lancing Device 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 Monitoring System is verified by the Control Solution.

- ട. Intended Use:
The Rightest Blood Glucose Monitoring System, Model GM550 is intended for in vitro diagnostic use (outside of body). It is indicated to be used by professional healthcare personnel in clinical settings or diabetics at home to measure the glucose concentration for aiding diabetes management.

The alucose concentration is measured with quantitative capillary whole blood from the fingertip, palm, and forearm by using Rightest Blood Glucose Monitoring

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System, GM550. This device is not intended for testing neonate blood samples and is not intended for the diagnosis of or screening for diabetes mellitus.

Rightest GS550 Blood Glucose Test Strips are intended for use with the Rightest GM550 Blood Glucose meter in the quantitative measurement of glucose in capillary whole blood from the fingertip, palm, and forearm.

Rightest Control Solutions are intended for use with the Rightest GM550 Blood Glucose meter to check that both the glucose meters and test strips are working properly. These solutions contain a known range of glucose, as indicated on the bottles.

#### . Predicate Device Information:

The Rightest Blood Glucose Monitoring System GM550 is substantially equivalent to the brand of Rightest Blood Glucose Monitoring System (Alternative Site Testing) noted below.

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

#### Comparison to Predicate Devices: 7.

| Specification | Rightest BGMS GM550 | Rightest BGMS GM300 |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| | (New Device) | (Predicate Device-K062567) |
| Interference | Uric acid $\geq$ 10 mg/dL | Uric acid > 9.0 mg/dL |
| Memory Capacity | 500 blood glucose test results<br>with date and time | 300 blood glucose test results with<br>date and time |
| Power Supply | Two CR2032 batteries | Two 1.5V (AAA) batteries |
| Power Saving | Turn off automatically 2 minutes<br>after last user action / Press the<br>main button for 4 seconds. | Turn off automatically after 3<br>minutes no use |
| Meter Dimension | 90.6 mm × 46 mm × 16.5 mm | 85.0 mm × 58.0 mm × 22.0 mm |
| Meter Weight | 53.0 ± 5 g with batteries | 85.0 g with batteries |
| Coding | Auto coding | Code key |
| Minimum Sample Volume | 1.0 microliter | 1.4 microliter |
| Test Time | 5 seconds | 8 seconds |
| Hematocrit Range | 30 - 60% | 30 - 55% |
| LCD display area | 47 mm × 33.5 mm | 39.0 mm × 38.0 mm |
| Strip Reagent | 1.Glucose Oxidase (GOD) 14.8%<br>2.Potassium ferricyanide 39.5%<br>3.Non-reactive ingredients 45.7% | 1.Glucose Oxidase (GOD) 8.5%<br>2.Potassium ferricyanide 48.5%<br>3.Non-reactive ingredients 43% |
| Control Solution Reagent<br>(Normal level) | 1.Water 84%<br>2.d-Glucose 0.1%<br>3.Viscosity enhancing agent 15%<br>4.Inorganic salts / Buffers 1.0%<br>5.Dye 0.08%<br>6.Preservative 0.03% | 1.Water 83%<br>2.d-Glucose 0.1%<br>3.Viscosity enhancing agent 15%<br>4.Inorganic salts / Buffers 1.4%<br>5.Dye 0.005%<br>6.Preservative 0.03% |
| Control Solution Reagent<br>(High level) | 1.Water 69%<br>2.d-Glucose 0.3%<br>3.Viscosity enhancing agent 29.5%<br>4.Inorganic salts / Buffers 1.0%<br>5.Dye 0.08%<br>6.Preservative 0.03% | 1.Water 83%<br>2.d-Glucose 0.3%<br>3.Viscosity enhancing agent 15%<br>4.Inorganic salts / Buffers 1.4%<br>5.Dye 0.005%<br>6.Preservative 0.03% |
| Measurement Technology | Oxidase Electrochemical Sensor | |
| Sample | Capillary whole blood | |
| Measuring Range | 20-600 mg/dL | |
| Operating Tempature<br>Range | 10 ~ 40°C (50 ~ 104 °F) | |
| Operating Relative Humidity<br>Range | 10 ~ 90% | |
| Battery Life | About 1000 tests | |
| Meter Storage Conditions | -10 ~ 60°C (14 ~ 140 °F) | |
| Test Strip Storage<br>Conditions | 4 ~ 30°C (39 ~ 86 °F), < 90% relative humidity | |
| The unit of measurement<br>data | Fix on mg/dL | |

# Specification Comparison

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#### 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 and hematocrit.

#### Discussion of Clinical Tests Performed: ഗ്

## System Accuracy Study:

For the alternative site:

The accuracy of the alternative site test study of the Rightest™ Blood Glucose Monitoring System was proved by comparing whole blood (plasma equivalent) glucose values on the Rightest™ meter with plasma qlucose values on a lab instrument.

A total of 114 patients participated. Each patient collected and tested their own blood samples (from the fingertip, palm and forearm) with the Rightest™ meter. Another blood sample was collected within 5 minutes and got the plasma to be analyzed by the lab instrument. Ninety-seven percent of the test results were within ± 20% of the comparison method results at glucose concentrations ≥75 mg/dL and within ±15 mg/dL at glucose concentrations < 75 mg/dL.

The Results and differences between the two methods, the Rightest Blood Glucose Monitoring System and the Olympus 2700 (Lab instrument used as the reference method) are demonstrated in the tables below.

### User Performance Study:

A user performance study was performed to demonstrate that lay consumers could obtain accurate results using the subject device. The study was performed using capillary whole blood from fingertip, palm, forearm, and upper arm sample sites.

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Table 1: represents samples for glucose results lower than 75 mg/dL.

| | The percent ( and number ) of samples for which the difference | | |
|-----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|---------------|---------------|
| Difference range in values<br>between the Olympus value<br>and the Rightest meter value | between the Rightest meter value ( Alternative site ) and the<br>Olympus value were within the difference range shown in the<br>side row. | | |
| | Fingertip | Palm | Forearm |
| Within ± 5 mg/dL | 78.9% (15/19) | 78.9% (15/19) | 42.1% (8/19) |
| Within ± 10 mg/dL | 100% (19/19) | 94.7% (18/19) | 78.9% (15/19) |
| Within ± 15 mg/dL | 100% (19/19) | 100% (19/19) | 94.7% (18/19) |

Table 2: represents samples for glucose results greater than 75 mg/dL.

| | The percent ( and number ) of samples for which the difference | | |
|------------------------------|----------------------------------------------------------------|---------------|---------------|
| Difference range in values | between the Rightest meter value ( Alternative site ) and the | | |
| between the Olympus value | (Olympus value were within the difference range shown in the | | |
| and the Rightest meter value | side row. | | |
| | Fingertip | Palm | Forearm |
| Within ± 5% | 55.8% (53/95) | 55.8% (53/95) | 49.5% (47/95) |
| Within ± 10% | 75.8% (72/95) | 75.8% (72/95) | 71.6% (68/95) |
| Within ± 15% | 91.6% (87/95) | 89.5% (85/95) | 91.6% (87/95) |
| Within ± 20% | 96.8% (92/95) | 96.8% (92/95) | 97.9% (93/95) |

The "Alternative Site Test" clinical evaluation shows substantial equivalence to Rightest Blood Glucose Monitoring System used in fingertip, palm and forearm position. So the result tells us Rightest blood glucose monitoring system GM550 is suitable to be used in fingertip, palm and forearm.

#### Conclusions: 10.

Results of clinical testing demonstrate that the performance of the Rightest Blood Glucose Monitoring System GM550 testing capillary whole blood is substantial equivalence of Rightest Blood Glucose Monitoring System GM300 (AST). The precision and accuracy of Rightest Blood Glucose Monitoring System GM550 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

Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

JUN 18 100

Bionime Corporation c/o Ms. Susan D. Goldstein-Falk Official Correspondent for Bionime Corporation 55 Northern Blvd. Suite 200 Great Neck, New York 11021

k092052 Re:

Trade Name: Rightest Blood Glucose Monitoring System, Model GM550 Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Codes: NBW, CGA, JJX Dated: June 04, 2010 Received: June 07, 2010

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 l edonal agencies: "1 ou and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 11mmod to: registration and medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

C.A.C.

Courtney C. Harper, 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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### EXHIBIT B

Page 1 of 1

# Indications for Use

### K092052 510(k) Number (if known):

Device Name: Rightest Blood Glucose Monitoring System, Model GM550

Indications For Use:

The Rightest Blood Glucose Monitoring System, Model GM550 is intended for the quantitative measurement of glucose in capillary whole blood from the fingertip, palm and forearm by professional healthcare personnel in clinical settings or diabetics at home to measure the glucose concentration for aiding diabetes management.

This device is not intended for testing neonate blood samples and is not intended for the diagnosis of or screening for diabetes mellitus.

Rightest Blood Glucose Test Strips GS550 are intended for use with the Rightest GM550 Blood Glucose meter in the quantitative measurement of glucose in capillary whole blood from the fingertip, palm and forearm.

Rightest Control Solutions are intended for use with the Rightest Blood Glucose Monitoring System, Model GM550 to check that both the glucose meters and test strips are working properly. These solutions contain a known range of glucose, as indicated on the bottles.

AND/OR Prescription Use × (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

Office of In Vitro Diagnostic Device Evaluation and Safety