The Rightest Professional Blood Glucose Monitoring System GM720 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 and in venous and arterial whole blood. The Rightest Professional Blood Glucose Monitoring System GM720 is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with auto-disabling, single-use lancing devices. The Rightest Professional Blood Glucose Monitoring System GM720 should not be used for the diagnosis of, or screening for testing neonate blood samples. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The Rightest Professional Blood Glucose Test Strips GS720 are for use with the Rightest Professional Blood Glucose Meter GM720 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm and in venous and arterial whole blood samples.

The Rightest Blood Glucose Monitoring System GM720 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 GM720 is intended to be used by a single person and should not be shared.

The Rightest Blood Glucose Monitoring System GM720 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 GM720 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 GS720 are for use with the Rightest Blood Glucose Meter GM720 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

Device Description

The Rightest Blood Glucose Monitoring System GM720 consists of the following devices: Rightest Blood Glucose Meter GM720, Rightest Blood Glucose Test Strip GS720, Rightest Control Solution GC700, lancing device and sterile lancets. The Rightest Blood Glucose Meter GM720, Rightest Blood Glucose Test Strips GS720, and Lancing Device are manufactured by BIONIME Corporation.

The Rightest Professional Blood Glucose Monitoring System GM720 consists of the following devices: Rightest Professional Blood Glucose Meter GM720, Rightest Professional Blood Glucose Test Strip GS720, and Rightest Control Solution GC700. This system should only be used with auto-disabling, single-use lancing devices and sterile lancets. The Rightest Professional Blood Glucose Meter GM720 and Rightest Professional Blood Glucose Test Strips GS720 are manufactured by BIONIME Corporation.

Biomine's Rightest™ GM720 system is an electronic device that utilizes the electrical characteristic technology for measuring the glucose level in human blood. A relatively small drop of blood is placed on a disposable test strip coated with FAD-glucose Dehydrogenase (FAD-GDH). Within five seconds, the level of blood glucose will be shown on the digital display screen.

Rightest™ Blood Glucose Monitoring System GM720, with an auto-coding feature, requires only minimum of 0.75 microliter of blood for the testing, therefore it reduces the time and effort required for testing and improves the compliance of diabetic people to their testing regimens.

AI/ML Overview

Device Name: Bionime Rightest™ Blood Glucose Monitoring System GM720, Bionime Rightest™ Professional Blood Glucose Monitoring System GM720

This response describes the acceptance criteria and the study that proves the device meets those criteria, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state the numerical acceptance criteria for the system accuracy study in a clear, tabulated format. However, it states that "The accuracy study... demonstrates that the accuracy of Rightest Blood Glucose Monitoring System GM720 met the acceptance criteria." This implies that predefined criteria were used and successfully met.

Based on the general context of blood glucose monitoring systems, acceptance criteria typically align with standards like ISO 15197 for accuracy. Common criteria are usually expressed as a percentage of measurements falling within a certain deviation from a reference method, particularly at different glucose concentration ranges. Without the specific numerical thresholds, it's impossible to create a precise table.

However, the reported performance is implicitly that the device did meet these unstated acceptance criteria.

Note: The document only states that the device "met the acceptance criteria" without providing the specific numerical targets for accuracy (e.g., % within ±15 mg/dL or ±15%). For a comprehensive answer, these numerical criteria would be needed.

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

System Accuracy Study (Test Set):
- Sample Size: 121 patients were recruited.
- Data Provenance: Not specified in the provided text (e.g., country of origin). The study involved "whole blood (plasma equivalent) glucose values" and "plasma glucose values on a lab instrument," suggesting a clinical setting.
- Retrospective/Prospective: Not explicitly stated, though the recruitment of "patients" for a study generally implies a prospective collection of data for the purpose of the study.
User Performance Study (Test Set):
- Sample Size: 165 laypersons.
- Data Provenance: Not specified (e.g., country of origin).
- Retrospective/Prospective: Not explicitly stated, but recruiting "laypersons" to demonstrate they "could obtain accurate results using the subject device" strongly suggests a prospective study design.

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

The document mentions "plasma glucose values on a lab instrument" as the comparator for the System Accuracy Study.

Number of Experts: Not explicitly stated. The ground truth would typically be established by laboratory technicians or medical professionals operating the reference laboratory instrument.
Qualifications of Experts: Not explicitly stated. However, personnel operating a "lab instrument" for plasma glucose measurements are expected to be trained and qualified in clinical laboratory procedures.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method for either the System Accuracy Study or the User Performance Study. The System Accuracy Study directly compared the device's readings to a lab instrument's plasma glucose values, implying a direct comparison rather than an adjudication process involving multiple interpretations of results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study, comparing human readers with AI assistance versus without AI assistance, was not conducted or reported in the provided text. This device is a blood glucose monitoring system, which directly measures glucose levels and does not involve human interpretation or AI assistance in the reading of results in the way a medical imaging AI would.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone performance study was done. The "System Accuracy Study" evaluated the "Rightest Blood Glucose Monitoring System GM720" by comparing its glucose values directly with a reference lab instrument. This represents the standalone performance of the device itself, without human intervention in the result generation or interpretation beyond the standard operation of the device.

7. Type of Ground Truth Used

For System Accuracy Study: The ground truth was established using plasma glucose values on a lab instrument. This is a highly accurate and standardized method typically used as a reference in clinical laboratories for glucose measurement.
For User Performance Study: The ground truth was implicitly the same (laboratory reference method), as the study aimed to demonstrate that lay users could obtain "accurate results" comparable to the performance already established by the system accuracy study.

8. Sample Size for the Training Set

The provided document does not mention a training set. This is typical for a medical device like a blood glucose meter, which relies on electrochemical measurement principles rather than machine learning algorithms that require extensive training data. The device's performance is based on its hardware and firmware design, not a learning algorithm developed using a "training set."

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

As no training set is mentioned or applicable for this type of device, this question is not relevant.

Summary

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

BIONIME CORPORATION C/O FENG-YU LEE IVDD REGULATORY CONSULTANT 29222 RANCHO VIEJO ROAD, SUITE 218 SAN JUAN CAPISTRANO CA 92675

August 22, 2014

Re: K140210

Trade/Device Name: Bionime Rightest™ Blood Glucose Monitoring System GM720, Bionime Rightest™ Professional Blood Glucose Monitoring System GM720 Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, LFR Dated: August 15, 2014 Received: August 18, 2014

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 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); medical device reporting (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.

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 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 yours,

Katherine Serrano -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

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Indications for Use

510(k) Number (if known) K140210

Device Name

Rightest Professional Blood Glucose Monitoring System GM720

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FOR FOR FOR FOR FOR FOR FOR 发 - 905年 - 19 And Article Production Comers of the States of the States of the States of the States of the States of the Comments of the with the with the with the with the was and the was Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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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

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K140210

Device Name

Rightest Blood Glucose Monitoring System GM720

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

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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

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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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 SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is: K140210

Submitter's Identification: 1.
BIONIME CORPORRATION 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: August 20, 2014

1. Contact Persons:
  Primary Contact: Mrs. Feng-Yu Lee Correspondent for this Application Bionime Corporation c/o IVDD Regulatory Consultant 29222 Rancho Viejo Road, Suite 218 San Juan Capistrano Tel: (949) 218-0929 Fax: (949) 218-0928 fengyulee@jvddreg.com
Name of the Device: 3. Rightest Blood Glucose Monitoring System GM720 Rightest Professional Blood Glucose Monitoring System GM720
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
LFR; Glucose Dehydrogenase,Glucose	Class II	21 CFR 862.1345	Clinical Chemistry 75

1. Device Description:
  The Rightest Blood Glucose Monitoring System GM720 consists of the following devices: Rightest Blood Glucose Meter GM720, Rightest Blood Glucose Test Strip GS720, Rightest Control Solution GC700, lancing device and sterile lancets. The Rightest Blood Glucose Meter GM720, Rightest Blood Glucose Test Strips GS720, and Lancing Device are manufactured by BIONIME Corporation.

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న్. Intended Use:

Device Name: Rightest Blood Glucose Monitoring System GM720

The Rightest Blood Glucose Monitoring System GM720 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 GM720 is intended to be used by a single person and should not be shared.

Device Name: Rightest Professional Blood Glucose Monitoring Svstem GM720

The Rightest Professional Blood Glucose Monitoring System GM720 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertins, forearm or palm and in venous and arterial whole blood. The Rightest Professional Blood Glucose Monitoring System GM720 is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with auto-disabling, single-use lancing devices. The Rightest Professional Blood Glucose Monitoring System GM720 should not be used for the diagnosis of, or screening for diabetes, nor for testing neonate cord blood samples. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

6. Predicate Devices Information:

The Rightest Blood Glucose Monitoring System GM720 and Rightest Professional Blood Glucose Monitoring System GM720 are substantially equivalent to the following device:

Name:	ACCU-CHEK Performa Blood Glucose Monitoring System
Device Company:	Roche Diagnostics Corporation
510(K) Number:	K070585

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7. Comparisons to Predicate Devices:

Specification Comparison

	SUPERTERMANT COMITH ADDITICandidate Device	Predicate Device
	Rightest Professional GM720	ACCU-CHEK Performa BGMS(K070585)
Intended Use	It is intended to be used forquantitative measurement ofglucose in fresh whole blood asan aid to monitor theeffectiveness of diabetescontrol.	Same
Measuring Range	20-600 mg/dL	10-600 mg/dL
Testing Samples	Fresh capillary whole bloodfrom the fingertips, palm,forearm.Venous Whole BloodArterial Blood	Fresh capillary whole blood from thefingertips, palm, forearm, upper arm,thigh and calf.Venous Whole BloodNeonatal BloodArterial Blood
MeasurementTechnology	DehydrogenaseElectrochemical Sensor	Same
Strip Reagent	FAD-glucose Dehydrogenase:12.1%Potassium ferricyanide: 48.5%Non-reactive ingredients:39.4%	Mediator: 6.72%Quinprotein glucose dehydrogenase:15.27%Pyrroloquinoline quinone: 0.14%Buffer: 34.66%Stabilizer: 0.54%Non-reactive ingredients: 42.66%
Test Time	5 seconds	Same
Coding	Auto-coding	Code Key
OperatingTemperatureRange	43~~111°F (6~~44°C )	40~~113°F (8~~44°C)
Operating RelativeHumidity Range	10-90%	Same
Test Strip StorageConditions	39~~86 °F (4~~ 30°C ), 10-90%relative humidity	59~~86°F (2~~30°C)
Minimum SampleVolume	0.75 µL	0.6 uL
Hematocrit Range	20-65%	10-70%
Memory Capacity	1000 blood glucose test resultswith date and time	500 blood glucose test results withdate and time
Meter Dimensions	71.5 × 39.5 × 14.0 mm (LWH)	93 x 52 x 22 mm (LWH)
Meter weight	50.0 ± 5 g with batteries	62 g with battery

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8. Technology Characteristics:

9. 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 GM720. The evaluation included precision, linearity, interference, sample volume and hematocrit.

10. Discussion of Clinical Tests Performed:

System Accuracy Study:

The accuracy study of the Rightest Blood Glucose Monitoring System GM720 was performed by comparing whole blood (plasma equivalent) glucose values on the Rightest Blood Glucose meter GM720 with plasma glucose values on a lab instrument.

A total of 121 patients were recruited. The study result demonstrates that the accuracy of Rightest Blood Glucose Monitoring System GM720 met the acceptance criteria.

User Performance Study:

A User Performance Evaluation Study was performed to demonstrate that lay users could obtain accurate results using the subject device. The study was performed using capillary whole blood from fingertip, palm and forearm sample sites by evaluating total of 165 laypersons in multiple sites. The study result shows substantial equivalence to predicate device used in finger, palm and forearm position.

11. Conclusions:

Results of performance evaluation of the Rightest Blood Glucose Monitoring System GM720 demonstrate that the Rightest BGMS and Rightest Professional BGMS GM720 are substantial equivalence to the predicate device, ACCU-CHEK Performa 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.