RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 GE GE200 BLOOD GLUCOSE MONITORING SYSTEM RIGHTEST BLOOD GLUCOSE MONITORIN

K123008 · Bionime Corporation · NBW · Jan 25, 2013 · Clinical Chemistry

Device Facts

• Record ID: K123008
• Device Name: RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 GE GE200 BLOOD GLUCOSE MONITORING SYSTEM RIGHTEST BLOOD GLUCOSE MONITORIN
• Applicant: Bionime Corporation
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jan 25, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

The Rightest Blood Glucose Monitoring System GM700 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The Rightest Blood Glucose Monitoring System GM700 is intended to be used by a single person and should not be shared. The Rightest Blood Glucose Monitoring System GM700 is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Rightest Blood Glucose Monitoring System GM700 should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). The Rightest Blood Glucose Test Strips GS700 are for use with the Rightest Blood Glucose Meter GM700 to quantitatively measure alucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

Device Story

Blood glucose monitoring systems (meters and test strips) for quantitative glucose measurement in capillary whole blood; intended for single-patient home use. Modifications include updated device naming, adjusted test strip reagent percentages, revised interference concentration thresholds (uric acid, ascorbic acid, dopamine HCl, L-Dopa), reduced sample volume (1.0 μl to 0.75 μl), and changes to meter dimensions, weight, and power supply. Systems utilize electrochemical biosensor technology to measure glucose levels. Users apply blood sample to test strip; meter processes signal to display glucose concentration. Results assist patients in monitoring diabetes control. Cleaning/disinfection validated for 550 cycles using Discide Ultra towelettes to ensure material integrity over 5-year simulated use.

Clinical Evidence

Bench testing only. Validation included performance testing of modified test strip reagents and interference thresholds. Material integrity testing confirmed no degradation after 550 cleaning/disinfection cycles using Discide Ultra towelettes, simulating 5 years of use. Hepatitis B surface antigen testing validated the efficacy of the disinfection protocol on meter and lancing device materials.

Technological Characteristics

Electrochemical glucose biosensor system. Modifications: reduced sample volume (0.75 μl), adjusted reagent concentrations, and updated meter physical dimensions/power supply. Connectivity: standalone. Sterilization: not applicable (non-sterile). Software: embedded firmware for signal processing and glucose calculation.

Indications for Use

Indicated for the quantitative measurement of glucose in fresh capillary whole blood from the fingertip, palm, or forearm by people with diabetes at home as an aid to monitor the effectiveness of diabetes control programs.

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 Glucose Monitoring System GM700 (k110737)
• Bionime Rightest Blood Glucose Monitoring System, Model GM650 (k120423)
• GE Talking Blood Glucose Monitoring System, Model GE300 (k120423)

Submission Summary (Full Text)

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### Exhibit #1

### . 510(K) SUMMARY

# JAN 2 5 2013

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: \(123008

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

Date Summary Prepared: September 24, 2012

- 2. Name of the Device: Rightest Blood Glucose Monitoring System GM700 GE200 Blood Glucose Monitoring System Rightest Blood Glucose Monitoring System GM650 GE300 Talking Blood Glucose Monitoring System
- 3. Common or Usual Name: Glucose test system

| Product Code | Classification | Regulation Section | Panel |
|-------------------------------------------------------|----------------|--------------------|--------------------------|
| NBW; System, Test, Blood<br>Glucose, Over-the-Counter | Class II | 21 CFR 862.1345 | Clinical Chemistry<br>75 |
| LFR; Glucose<br>Dehydrogenase, Glucose | Class II | 21 CFR 862.1345 | Clinical Chemistry<br>75 |

### Device Description: 4.

4.1 Our Rightest Blood Glucose Monitoring System GM700 consists of the following devices: Rightest Blood Glucose Meter GM700, Rightest Blood Glucose Test Strip GS700, Rightest Control Solution GC700, lancing device and sterile lancets. The Rightest Blood Glucose Meter GM700, Rightest Blood Glucose Test Strips GS700, and Lancing Device are manufactured by BIONIME Corporation. The Rightest Blood Glucose Meter GM700, when used with the Rightest Blood Glucose Test Strips GS700, quantitatively measures glucose in fresh capillary whole blood. The performance of the Rightest Blood Glucose Monitoring System GM700 is verified by the Rightest Control Solution GC700.

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4.2 Our GE200 Blood Glucose Monitoring System consists of the following devices: GE200 Blood Glucose Meter, GE200 Blood Glucose Test Strip, GE200 Control Solution, lancing device and sterile lancets. The GE200 Blood Glucose Meter, GE200 Blood Glucose Test Strips, and Lancing Device are manufactured by BIONIME Corporation. The GE200 Blood Glucose Meter, when used with the GE200 Blood Glucose Test Strips, quantitatively measures glucose in fresh capillary whole blood. The performance of the GE200 Blood Glucose Monitoring System is verified by the GE200 Control Solution.

4.3 Our Rightest Blood Glucose Monitoring System GM650 consists of the following devices: Rightest Blood Glucose Meter GM650, Rightest Blood Glucose Test Strip GS650, Rightest Control Solution GC650, lancing device and sterile lancets. The Rightest Blood Glucose Meter GM650. Rightest Blood Glucose Test Strips GS650, and Lancing Device are manufactured by BIONIME Corporation. The Rightest Blood Glucose Meter GM650, when used with the Rightest Blood Glucose Test Strips GS650, quantitatively measures glucose in fresh capillary whole blood. The performance of the Rightest Blood Glucose Monitoring System GM650 is verified by the Rightest Control Solution GC650.

4.4 Our GE300 Talking Blood Glucose Monitoring System consists of the following devices: GE300 Talking Blood Glucose Meter, GE300 Talking Blood Glucose Test Strip, GE300 Series Control Solution, lancing device and sterile lancets. The GE300 Talking Blood Glucose Meter. GE300 Talking Blood Glucose Test Strips, and Lancing Device are manufactured by BIONIME Corporation. The GE300 Talking Blood Glucose Meter, when used with the GE300 Talking Blood Glucose Test Strips, quantitatively measures glucose in fresh capillary whole blood. The performance of the GE300 Talking Blood Glucose Monitoring System is verified by the GE300 Series Control Solution.

#### 5. Intended Use:

5.1 The Rightest Blood Glucose Monitoring System GM700 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The Rightest Blood Glucose Monitoring System GM700 is intended to be used by a single person and should not be shared.

The Rightest Blood Glucose Monitoring System GM700 is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Rightest Blood Glucose Monitoring System GM700 should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

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The Rightest Blood Glucose Test Strips GS700 are for use with the Rightest Blood Glucose Meter GM700 to quantitatively measure alucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm,

5.2 The GE200 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The GE200 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The GE200 Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The GE200 Blood Glucose Monitoring System should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The GE200 Blood Glucose Test Strips are for use with the GE200 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

5.3 The Rightest Blood Glucose Monitoring System GM650 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The Rightest Blood Glucose Monitoring System GM650 is intended to be used by a single person and should not be shared.

The Rightest Blood Glucose Monitoring System GM650 is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Rightest Blood Glucose Monitoring System GM650 should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The Rightest Blood Glucose Test Strips GS650 are for use with the Rightest Blood Glucose Meter GM650 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

5.4 The GE300 Talking Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The GE300 Talking Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

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The GE300 Talking Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The GE300 Talking Blood Glucose Monitoring System should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The GE300 Talking Blood Glucose Test Strips are for use with the GE300 Talking Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

### 6. Predicate Device Information:

The Rightest Blood Glucose Monitoring System GM700 and the GE200 Blood Glucose Monitoring System are substantially equivalent to the brand of Rightest Blood Glucose Monitoring System noted below.

Name: Rightest Blood Glucose Monitoring System GM700 Device Company: Bionime Corporation 510(K) Number: K110737.

The Rightest Blood Glucose Monitoring System GM650 and the GE300 Talking Blood Glucose Monitoring System are substantially equivalent to the brand of Rightest Blood Glucose Monitoring System noted below.

Name: Rightest Blood Glucose Monitoring System GM650 Device Company: Bionime Corporation 510(K) Number: K120423.

### 7. Comparison to Predicate Devices:

Specification Comparison

| Item | New Device | Predicate Device | |
|-----------------|----------------|--------------------------|--|
| | GE200 | Rightest GM700 (k110737) | |
| | Rightest GM700 | | |
| | Similarities | | |
| Test Time | 5 seconds | | |
| Measuring Range | 20-600 mg/dL | | |

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| Hematocrit Range | 30 - 55% | | | |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Operating Relative Humidity<br>Range | 10 ~ 90% | | | |
| Operating Temperature Range | 43~111 °F (6~44°C ) | | | |
| Battery Life | About 1000 tests | | | |
| Monitor | LCD display | | | |
| Memory Capacity | 1000 blood glucose test results with date and time | | | |
| Coding | Auto coding | | | |
| Meter Storage Conditions | 14~140 °F (-10 ~ 60°C ) | | | |
| Test Strip Storage Conditions | 39~86 °F (4 ~ 30°C), <90% relative humidity | | | |
| The unit of measurement data | Fix on mg/dL | | | |
| Sample | Capillary whole blood | | | |
| Measurement Technology | Dehydrogenase Electrochemical Sensor | | | |
| | Differences | | | |
| Minimum Sample Volume | 0.75 microliter | 1.0 microliter | | |
| Interference | Uric acid ≥ 16 mg/dL<br>Xylose ≥ 10 mg/dL<br>Ascorbic acid ≥ 3 mg/dL<br>Dopamine HCI ≥ 1.25 mg/dL<br>L-Dopa ≥ 2 mg/dL | Uric acid ≥ 10 mg/dL<br>Xylose ≥ 10 mg/dL | | |
| | Strip Reagent | 1.FAD-glucose Dehydrogenase<br>(FAD-GDH) 12.1%<br>2.Potassium ferricyanide 48.5%<br>3.Non-reactive ingredients<br>39.4% | 1.FAD-glucose Dehydrogenase<br>(FAD-GDH) 9.0%<br>2.Potassium ferricyanide 53.7%<br>3.Non-reactive ingredients<br>37.3% | |
| | | Power Supply | Two CR2032<br>batteries | One CR2032 batteries |
| | | Meter Dimension | 96mm*46mm*1<br>7.5mm | 98 mm × 46 mm × 17.5 mm |
| | Meter Weight | 65.0 ± 5 g with<br>batteries | 57.0 ± 5 g with batteries | |
| Backlight | Yes | No | | |
| Control solution | Level 1, 2 and 4 | L1, L2, L3, L4, L5 | | |

.

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# Specification Comparison

| Item | New Device | Predicate Device |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| | Rightest GM650 /<br>GE300 Talking | Rightest GM650 (k120423) |
| | Similarities | |
| Minimum Sample Volume | 0.75 microliter | |
| Test Time | 5 seconds | |
| Measuring Range | 20-600 mg/dL | |
| Hematocrit Range | 30 - 55% | |
| Operating Relative Humidity<br>Range | 10 ~ 90% | |
| Operating Temperature Range | 43 ~ 111 °F (6 ~ 44°C ) | |
| Battery Life | About 1000 tests | |
| Monitor | LCD display | |
| Memory Capacity | 500 blood glucose test results with date and time | |
| Coding | Auto coding | |
| Meter Storage Conditions | 14 ~ 140 °F (-10 ~ 60°C ) | |
| Test Strip Storage Conditions | 39 ~ 86 °F (4 ~ 30°C ), <90% relative humidity | |
| The unit of measurement data | Fix on mg/dL | |
| Sample | Capillary whole blood | |
| Measurement Technology | Dehydrogenase Electrochemical Sensor | |
| Power Supply | Two 1.5V (AAA) batteries | |
| Meter Dimension | 50 mm × 18 mm × 105 mm | |
| Meter Weight | 80.0 ± 5 g with batteries | |
| LCD display area | 48 mm × 34 mm | |
| Backlight | No | |
| Control solution | Level 1, 2 and 4 | |
| Voice Function | Yes | |
| Data Transmission | Infrared | |
| Stereo jack | Yes | |
| Voice repeat button | Yes | |
| | Differences | |
| Interference | Uric acid ≥ 16 mg/dL<br>Xylose ≥ 10 mg/dL<br>Ascorbic acid ≥ 3 mg/dL<br>Dopamine HCI ≥ 1.25 mg/dL<br>L-Dopa ≥ 2 mg/dL | Uric acid ≥ 10 mg/dL<br>Xylose ≥ 10 mg/dL |
| Strip Reagent | 1.FAD-glucose Dehydrogenase<br>(FAD-GDH) 12.1%<br>2.Potassium ferricyanide 48.5%<br>3.Non-reactive ingredients<br>39.4% | 1.FAD-glucose Dehydrogenase<br>(FAD-GDH) 9.0%<br>2.Potassium ferricyanide 53.7%<br>3.Non-reactive ingredients<br>37.3% |

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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 GM700, the GE200 Blood Glucose Monitoring System, the Rightest Blood Glucose Monitoring System GM650, and the GE300 Talking Blood Glucose Monitoring System. The evaluation included precision, linearity, interference, sample volume and hematocrit.

### 9. Conclusions:

Results of performance evaluation of the Rightest Blood Glucose Monitoring System GM700, the GE200 Blood Glucose Monitoring System, the Rightest Blood Glucose Monitoring System GM650, and the GE300 Talking Blood Glucose Monitoring System demonstrate that the devise is substantial equivalence to the predicate

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device, Rightest Blood Glucose Monitoring System GM700 and Rightest Blood Glucose Monitoring System GM650.

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11

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Image /page/8/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is black. The text is centered in the image.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

### January 25, 2013

Bionime Corporation c/o MDI Consultant, Inc. Jigar Shah 55 Northern Blvd, Suite 200 Great Neck, NY 11021

Re: k123008

Trade/Device Name: Rightest Blood Glucose Monitoring System GM700,

GE200 Blood Glucose Monitoring System

Rightest Blood Glucose Monitoring System GM650 GE300 Talking Blood Glucose Monitoring System

Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, LFR Dated: December 27, 2012 Received: December 28, 2012

Dear Mr. Shah: .

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2— Mr. Shah

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Carol C. Benson

Courtney H. Lias, Ph.D.

Director

Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics

and Radiological Health

Center for Devices and Radiological Health

Enclosure

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### Indications for Use

## 510(k) Number (if known): k123008

# Device Name: Rightest Blood Glucose Monitoring System GM700

### Indications For Use:

The Rightest Blood Glucose Monitoring System GM700 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The Rightest Blood Glucose Monitoring System GM700 is intended to be used by a single st Bioghest Blood Gloud on the shared.

The Rightest Blood Glucose Monitoring System GM700 is intended for self testing i outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Rightest Blood Glucose Monitoring System GM700 should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The Rightest Blood Glucose Test Strips GS700 are for use with the Rightest Blood Glucose Meter GM700 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

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 Diagnostics and Radiological Health (OlR)

# Katherine Serrano

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k) k123008

Page 1 of 4

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## 510(k) Number (if known):K123008

Device Name: GE200 Blood Glucose Monitoring System

Indications For Use:

The GE200 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The GE200 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The GE200 Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The GE200 Blood Glucose Monitoring System should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The GE200 Blood Glucose Test Strips are for use with the GE200 Blood Glucose drewn from the fively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

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 Diagnostics and Radiological Health (OlR)

# Katherine Serrano

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k) k123008

ﯩﯔ

Page 2 of 4

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### Indications for Use

### 510(k) Number (if known):K123008

# Device Name: Rightest Blood Glucose Monitoring System GM650

Indications For Use:

The Rightest Blood Glucose Monitoring System GM650 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The Rightest Blood Glucose Monitoring System GM650 is intended to be used by a single person and should not be shared.

The Rightest Blood Glucose Monitoring System GM650 is intended for self testing i outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Rightest Blood Glucose Monitoring System GM650 should not be used for the Rightest Dious Should Gillioning for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The Rightest Blood Glucose Test Strips GS650 are for use with the Rightest Blood Glucose Meter GM650 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or paim.

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 Diagnostics and Radiological Health (OIR)

# Katherine Serrano

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k) k123008

Page 3 of 4

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### Indications for Use

## 510(k) Number (if known):K123008

### Device Name: GE300 Talking Blood Glucose Monitoring System

Indications For Use:

The GE300 Talking Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The GE300 Talking Blood Santa Monitoring System is intended to be used by a single person and should not be shared.

The GE300 Talking Blood Glucose Monitoring System is intended for self testing outside i the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The GE300 Talking Blood Glucose Monitoring System should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The GE300 Talking Blood Glucose Test Strips are for use with the GE300 Talking Blood Glucose Meter to quantities for Strips are of use with the GESU Taking Blood samples drawn from the fingertips, forearm or palm

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 Diagnostics and Radiological Health (OIR)

# Katherine Serrano

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k) k123008

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