The Rightest Blood Glucose Monitoring System GM280B is intended to 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 GM280B is intended to be used by a single person and should not be shared.

The Rightest Blood Glucose Monitoring System GM280B 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 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 Strip GS280 is used with Rightest meter GM280B for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

The GE Blood Glucose Monitoring System 182 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 GE Blood Glucose Monitoring System 182 is intended to be used by a single person and should not be shared.

The GE Blood Glucose Monitoring System 182 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 GE Blood Glucose Monitoring System 182 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 GE Blood Glucose Strip 180 is used with GE Blood Glucose Monitoring Meter 182 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 GM280 is intended to 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 GM280 is intended to be used by a single person and should not be shared.

The Rightest Blood Glucose Monitoring System GM280 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 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 Strip GS280 is used with Rightest meter GM280 for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

The GE Blood Glucose Monitoring System 180 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 GE Blood Glucose Monitoring System 180 is intended to be used by a single person and should not be shared.

The GE Blood Glucose Monitoring System 180 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 GE Blood Glucose Monitoring System 180 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 GE Blood Glucose Strip 180 is used with GE Blood Glucose Monitoring Meter 180 for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

Device Description

The Rightest and GE Blood Glucose Monitoring System series consists of the following devices: Blood Glucose Meter, Blood Glucose Test Strip, Control Solution, lancing device and sterile lancets. The Blood Glucose Meter, Blood Glucose Test Strips, and Lancing Device are manufactured by BIONIME Corporation.

The Rightest Blood Glucose Meter GM280 and Rightest Blood Glucose Meter GM280B, when used with the Rightest Blood Glucose Test Strips GS280, quantitatively measure glucose in fresh capillary whole blood. The performance of the Rightest Blood Glucose Monitoring System GM280 and Rightest Blood Glucose Monitoring System GM280B are verified by the Rightest Control Solution GC550.

The GE Blood Glucose Meter 180 and GE Blood Glucose Meter 182, when used with the GE Blood Glucose Test Strips 180, quantitatively measure glucose in fresh capillary whole blood. The performance of the GE Blood Glucose Monitoring System 180 and GE Blood Glucose Monitoring System 182 are verified by the Rightest Control Solution GC550.

AI/ML Overview

The provided text describes the acceptance criteria and the study conducted for the GE Blood Glucose Monitoring System series.

Here's an analysis based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The main criterion for a glucose monitoring system's accuracy is typically measured against a laboratory reference method. For this device, the acceptance criteria relates to the accuracy of the blood glucose measurements compared to the YSI 2300 Plus Glucose Analyzer.

Acceptance Criteria and Reported Device Performance (System Accuracy Study)

Criterion Category	Acceptance Criterion (Implicit from success statement)	Reported Device Performance (Implicit from success statement)
System Accuracy	The accuracy of the Rightest Blood Glucose Monitoring System GM280 met the acceptance criteria (specific numerical criteria not detailed in the provided text, but commonly derived from ISO 15197 standards for blood glucose monitoring systems).	The study results demonstrate that the accuracy of Rightest Blood Glucose Monitoring System GM280 met the acceptance criteria.
User Accuracy & Ease of Use	The user accuracy and ease of use met the acceptance criteria (specific numerical criteria not detailed).	The study results demonstrate that the user accuracy and ease of use (via participant questionnaire scoring) Rightest Blood Glucose Monitoring System GM280B met the acceptance criteria.

Note: The exact numerical acceptance criteria for system accuracy (e.g., percentage of readings within a certain deviation from the reference) are not explicitly stated in the provided documents but are implied to have been met. For such devices, commonly, the ISO 15197 standard for blood glucose monitoring systems is referenced, which specifies accuracy requirements (e.g., 95% of results must be within ±15 mg/dL for glucose concentrations < 100 mg/dL and within ±15% for glucose concentrations ≥ 100 mg/dL).

2. Sample Sizes Used for the Test Set and Data Provenance

System Accuracy Study:
- Sample Size: A total of 104 patients participated.
- Data Provenance: The document does not explicitly state the country of origin. It indicates the study used fresh capillary and venous whole blood samples. It is implied to be a prospective study, as patients "participated" in the study.
User Performance Study:
- Sample Size: A total of 135 subjects participated.
- Data Provenance: The document does not explicitly state the country of origin. It mentions "English speaking and reading lay users." It is implied to be a prospective study, as "subjects participated."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

For the System Accuracy Study, the ground truth was established by a laboratory instrument, the YSI 2300 Plus Glucose Analyzer. This is a highly accurate and widely accepted reference method for glucose measurement. Therefore, human experts were not directly used to establish the ground truth for individual measurements, but the operation and calibration of such an analyzer would be performed by qualified laboratory personnel.
For the User Performance Study, the ground truth was "user accuracy" and "ease of use" via a "participant questionnaire scoring." This implies the "ground truth" was derived from the users' ability to correctly use the device and their subjective feedback on ease of use. While this involves user self-assessment, the evaluation of the results would be done by qualified study personnel. The document does not specify the number or qualifications of experts involved in the design of the questionnaire or the assessment of its results.

4. Adjudication Method for the Test Set

For the System Accuracy Study, since the ground truth was established by a single, highly accurate laboratory instrument (YSI 2300 Plus Glucose Analyzer), no multi-expert adjudication method (like 2+1 or 3+1) would be necessary for individual glucose measurements.
For the User Performance Study, no adjudication method for establishing ground truth is mentioned, as it relies on participant questionnaire scoring for user accuracy and ease of use.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study, which typically applies to imaging diagnostics comparing human readers with and without AI assistance, was not conducted. This is a blood glucose monitoring system, not an imaging AI device. The studies described are for system accuracy and user performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

The "System Accuracy Study" can be considered a form of standalone performance evaluation for the device's measurement capability. It assesses the device's output against a reference standard, independent of user intervention (beyond sample collection), to quantify its inherent measurement accuracy. The "User Performance Study" then evaluates the device with human-in-the-loop (lay users), ensuring it performs accurately in user hands.

7. The Type of Ground Truth Used

System Accuracy Study: The ground truth was established using a laboratory reference method (YSI 2300 Plus Glucose Analyzer), which provides highly accurate glucose concentration values.
User Performance Study: The ground truth for "user accuracy" was likely determined by comparing the glucose readings obtained by lay users with the values from a reference method (though not explicitly stated whether the YSI was used for this part as well, it's standard practice). The "ease of use" ground truth was established via participant questionnaire scoring, which is a form of subjective user outcomes data.

8. The Sample Size for the Training Set

The provided document describes verification and validation studies (test sets) for the blood glucose monitoring system. It does not mention a training set or any machine learning/AI model training. Blood glucose meters do not typically involve a "training set" in the sense of AI/ML algorithms that learn from data. Their performance is based on their electrochemical design and calibration.

9. How the Ground Truth for the Training Set was Established

Since there is no mention of a "training set" or AI/ML model for this device, this question is not applicable based on the provided text. The device's functionality is based on established electrochemical principles, not on learned parameters from a data training set.

Summary

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them.

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

July 6, 2017

Bionime Corporation % Feng-Yu Lee, Principal Consultant Dynamic Biotech Inc. dba IVDD Regulatory Consultant 29222 Rancho Vieio Road. Suite 218 San Juan Capistrano, California 92675

Re: K170143

Trade/Device Name: GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, Rightest Blood Glucose Monitoring System GM280, Rightest Blood Glucose Monitoring System GM280B Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: May 30, 2017 Received: June 7, 2017

Dear Feng-Yu Lee:

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

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with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 and Part 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Kellie B. Kelm -S

for 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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510(k) Number (if known) K170143

Device Name

Rightest Blood glucose monitoring System GM280B

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

	Prescription Use (Part 21 CFR 801 Subpart D)
	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

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510(k) Number (if known) K170143

Device Name GE Blood glucose monitoring System 182

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☐ Prescription Use (Part 21 CFR 801 Subpart D)	☑ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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510(k) Number (if known) K170143

Device Name

Rightest Blood glucose monitoring System GM280

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------

Repackaging Use (Part 21 CFR 201.66) Subject to Discretion	Over-The-Counter Use (21 CFR 201.66) Subject to Discretion

| | Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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510(k) Number (if known) K170143

Device Name GE Blood glucose monitoring System 180

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
-----------------------------------------------------------------------	---------------------------------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

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510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.

The assigned 510(k) number is: K170143

1. Submitter's Identification:
  BIONIME CORPORATION NO 100, Sec. 2, Daqing St., South Dist., 40242 Taichung City, Taiwan Contact Person: Mr. Roy Huang Phone Number: 886-4-23692388 FAX Number: 886-4-22617568

Date Summary Prepared: July 6, 2017

1. Name of the Device: Rightest Blood Glucose Monitoring System GM280 Rightest Blood Glucose Monitoring System GM280B GE Blood Glucose Monitoring System 180 GE Blood Glucose Monitoring System 182
1. Common or Usual Name: Glucose test system

Product Code	Classification	Regulation Section	Panel
NBW; System, Test, BloodGlucose, Over-the-Counter	Class II	21 CFR 862.1345	Clinical Chemistry 75

4. Device Description:

The GE Blood Glucose Meter 180 and GE Blood Glucose Meter 182, when used with the GE Blood Glucose Test Strips 180, quantitatively measure glucose in fresh capillary whole

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blood. The performance of the GE Blood Glucose Monitoring System 180 and GE Blood Glucose Monitoring System 182 are verified by the Rightest Control Solution GC550.

న. Intended Use:

Rightest Blood Glucose Monitoring System GM280

The Rightest Blood Glucose Monitoring System GM280 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 GM280 is intended to be used by a single person and should not be shared.

The Rightest Blood Glucose Monitoring System GM280 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 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).

Rightest Blood Glucose Monitoring System GM280B

The Rightest Blood Glucose Monitoring System GM280B 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 GM280B is intended to be used by a single person and should not be shared.

The Rightest Blood Glucose Monitoring System GM280B 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 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).

GE Blood Glucose Monitoring System 180

The GE Blood Glucose Monitoring System 180 is intended to be used by a single person and should not be shared.

The GE Blood Glucose Monitoring System 180 is intended for self- testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the

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effectiveness of diabetes control. The GE Blood Glucose Monitoring System 180 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).

GE Blood Glucose Monitoring System 182

The GE Blood Glucose Monitoring System 182 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 GE Blood Glucose Monitoring System 182 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).

1. Predicate Device Information:
  The Rightest Blood Glucose Monitoring System GM280, Rightest Blood Glucose Monitoring System GM280B, GE Blood Glucose Monitoring System 180 and GE Blood Glucose Monitoring System 182 Blood Glucose Monitoring Systems are substantially equivalent to the following brand of Rightest Blood Glucose Monitoring System:

Name:	GE333 Blood Glucose Monitoring System
Device Company:	Bionime Corporation
510(K) Number:	K143387

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7. Comparison to Predicate Devices:

Specification Comparison

	Subject Devices		Predicate Device
Specification	Rightest GM280	Rightest GM280B	GE333
	GE180	GE182
Indications for Use	Over-The-Counter: For single-patient use only, in-vitro diagnostic use onlyby individuals with diabetes at home
MeasurementTechnology	Glucose Oxidase Electrochemical Sensor
Sample Type	Capillary whole blood
Minimum SampleVolume	0.75 µL
Primary Site Testing	Fingertip
Alternative Site Testing	Forearm, Palm
Unit of Measurement	mg/dL
Measuring Range	20-600 mg/dL
Measuring Time	5 seconds
Hematocrit	20-60 %
Control Solution	3 levels (Level 1, 2, and 4)Rightest Control Solution GC550
Maximum Altitude	10745 feet (3275 m)
Operating Conditions	Temperature 50 ~104 °F (10 ~ 40°C),10 ~ 90% Relative Humidity
Meter StorageConditions	14~140 °F (-10 ~ 60°C)
Test Strip StorageConditions	39~~86 °F (4~~30°C),10-90% relative humidity
Test Strip Shelf Life(After Opening)	3 months
Interference	Ascorbic acid > 3 mg/dLGlutathione reduced >60 mg/dLUric Acid > 12 mg/dL		Ascorbic acid ≥ 5 mg/dLCholesterol ≥ 600 mg/dLUric acid ≥ 10 mg/dL
Test Strip Reagent	Glucose Oxidase (GOD) 18.8 %Potassium Ferricyanide 37.7 %Non-reactive Ingredients 43.5 %	Glucose Oxidase (GOD)14.8%Potassium ferricyanide39.5%Non-reactive ingredients45.7%
Wireless module	No	Bluetooth 4.0(Low energy)
Memory Capacity	500 blood glucose test results with date and time
Power Saving	Turn off automatically 2 minutes after last user action /Press the main button for 3 seconds.
Coding	Auto coding
Monitor	LCD display
Backlight	No
Power Supply	One CR2032 battery	Two AAA batteries
Battery Life	1000 tests	About 800 tests
Meter Dimension	82mm45mm15.5mm	90.6mm46mm16.5mm
LCD display area	34 mm*27.5mm	39mm*39.5mm
Meter Weight	43.0± 5g with batteries	81.0 ± 5g with batteries
Color	white/gray	white/green

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

Verification and validation of these blood glucose systems evaluated to establish the performance, functionality, and reliability of the Rightest Blood Glucose Monitoring System GM280, Rightest Blood Glucose Monitoring System GM280B, GE Blood Glucose Monitoring System 180, and GE Blood Glucose Monitoring System 182 Blood Glucose Monitoring Systems. The evaluation included precision, linearity, interference, sample volume and hematocrit.

9. Discussion of Clinical Tests Performed:

System Accuracy Study:

The system accuracy study of the Rightest Blood Glucose Monitoring System GM280 was performed by comparing capillary and venous whole blood (plasma equivalent) glucose values on the Rightest Blood Glucose Meter GM280 with glucose values on lab instrument YSI 2300 Plus Glucose Analyzer.

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A total of 104 patients participated. The study results demonstrate that the accuracy of Rightest Blood Glucose Monitoring System GM280 met the acceptance criteria.

User Performance Study:

The user performance study was performed to demonstrate that English speaking and reading lay users across all educational backgrounds can easily understand and follow the labeling/user instructions to obtain accurate results while using Rightest Blood Glucose Monitoring System GM280B.

A total of 135 subjects participated. The study results demonstrate that the user accuracy and ease of use (via participant questionnaire scoring) Rightest Blood Glucose Monitoring System GM280B meet the acceptance criteria.

10. Conclusions:

Results of performance evaluation of the Rightest Blood Glucose Monitoring System GM280. Rightest Blood Glucose Monitoring System GM280B, GE Blood Glucose Monitoring System 180, and GE Blood Glucose Monitoring System 182 demonstrate that the devices are substantially equivalent to the predicate device, GE333 Blood Glucose Monitoring System.

Regulation Number and Section

§ 862.1345 Glucose test system.

(a)
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.(b)
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.