The Rightest Blood Glucose Monitoring System is intended for in vitro diagnostic use (outside of body). It is indicated to be used by professional healthcare personnel or people with diabetes at home to measure the glucose concentration for aiding diabetes management. The glucose concentration is measured with quantitative capillary whole blood from fingertip, palm and forearm by using Rightest Blood Glucose Monitoring System. This test device is not intended for testing neonate blood samples.

Device Description

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

AI/ML Overview

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a numerical or categorical format for performance metrics. Instead, it demonstrates performance through a comparison with a reference method (Olympus AU2700) and describes linearity and correlation. However, we can infer performance goals from the presented data (e.g., slopes close to 1).

Performance Metric	Acceptance Criteria (Implied/Inferred)	Reported Device Performance (Rightest BGMS GM100)
Linearity (Slope vs. Olympus-Plasma)	Ideally 1.0 (indicating perfect agreement)	Fingertrick: 0.99Palmstick: 0.96Armstick: 0.96
Linearity (Intercept vs. Olympus-Plasma)	Ideally 0.0 (indicating no systematic bias)	Fingertrick: 0.74Palmstick: 6.35Armstick: 0.46
Correlation Coefficient (r vs. Olympus-Plasma)	Ideally 1.0 (indicating strong correlation)	Fingertrick: 0.993Palmstick: 0.990Armstick: 0.987
Test Range	Sufficient to cover diabetic glucose levels	20 - 600 mg/dL
Sample Source Equivalence	Demonstrate comparable results across different alternative sites (fingertip, palm, forearm)	Slopes and intercepts for fingertip, palm, and forearm are similar, showing substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size (Test Set): 164 for each test site (fingerstick, palmstick, armstick).
Data Provenance: The document doesn't explicitly state the country of origin. It describes the study as "clinical test was designed in Alternative site testing study" and conducted by "Technician," but no information about recruitment location is provided. The study appears to be prospective as it involves the collection of blood samples for testing.

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

This information is not provided in the given text. The ground truth (reference values) was established using the Olympus AU2700, which is an automated laboratory analyzer, not human experts.

4. Adjudication Method for the Test Set:

This information is not applicable as the ground truth was established by an automated reference analyzer (Olympus AU2700), not human interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable. The device is a Blood Glucose Monitoring System, an in vitro diagnostic device that provides a direct numerical result. It does not involve human readers interpreting images or data where AI assistance would be relevant in the context of an MRMC study.

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

Yes, a standalone performance evaluation was done. The study directly compares the results of the Rightest Blood Glucose Monitoring System (algorithm only) to a reference laboratory instrument (Olympus AU2700) without human intervention in the device's measurement process.

7. The Type of Ground Truth Used:

The ground truth used was reference laboratory method results from the Olympus AU2700 analyzer which measures "Olympus-Plasma" glucose concentrations. This serves as the comparative standard for the device's performance.

8. The Sample Size for the Training Set:

This information is not provided in the supplied text. The document describes clinical validation but does not detail the training set used for the device's development.

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

This information is not provided in the supplied text.

Summary

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Exhibit 1

510(K) SUMMARY

This summary of 5l0(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:_KQ8 145

Submitter's Identification: 1.
BIONIME CORPORRATION BIONME CONT ORFORD, DALI CITY, TAICHUNG COUNTY, TAIWAN 412 Contact Person: Mr. George Chi Phone Number: 886-4-24951268 FAX Number: 886-4-24952568

Date Summary Prepared: July 13, 2007

Name of the Device: Rightest Blood Glucose Monitoring System, Model GM100 2.
Common or Usual Name: Glucose test system 3. Panel: Clinical Chemistry 75 Product Code: NBW, System, Test, Blood Glucose, Over-the-Counter. Classification: Class II
1. Device Description:

Intended Use: 5.
The Rightest Blood Glucose Monitoring System is intended for in vitro diagnostic use (outside of body). It is indicated to be used by professional healthcare personnel or people with diabetes at home to measure the glucose concentration for aiding diabetes management. The glucose concentration is measured with quantitative capillary whole blood from fingertip, palm and forearm by using Rightest Blood Glucose Monitoring System. This test device is not intended for testing neonate blood samples.

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

Predicate Device Information: ે.

The Rightest Blood Glucose Monitoring System, model GM100 is substantially equivalent to the brand of Rightest Blood Glucose Monitoring System (Alternative Site Testing) noted below.

Rightest Blood Glucose Monitoring System, model GM100 Name: Device Company: Bionime Corporation K042678, K053635 and K062567 510(K) Number:

	Similarities
Item	Subject Device	Predicate Device(s)
	Rightest BGMS GM100(Alternative Site Testing)	Rightest BGMS(Alternative Site Testing)
Detection method	Amperometry	Amperometry
Enzyme	Glucose Oxidase(Aspergillus niger)	Glucose Oxidase(Aspergillus niger)
Mediator	Potassium ferricyanide	Potassium ferricyanide
Hematocrit Range	30 - 55%	30 - 55%
Temperature range	50 - 104° F10 - 40° C	50 - 104° F10 - 40° C
Humidity range	10 - 90%	10 - 90%
Warranty(meter)	3 years	3 years
Open use time(strip)	3 months	3 months
Electrode	Noble metal electrode	Noble metal electrode
Test range	20 - 600 mg/dL	20 - 600 mg/dL
Test Time	8 seconds	8 seconds
Sample Volume	1.4 uL	1.4 uL
Sample Source	The glucoseconcentration ismeasured withquantitative capillarywhole blood from thefingertip, palm andforearm by using RightestBlood GlucoseMonitoring System.	The glucoseconcentration ismeasured withquantitative capillarywhole blood from thefingertip, palm andforearm by using RightestBlood GlucoseMonitoring System.
The unit ofmeasurement data	Fix on mg/dL	Fix on mg/dL

Comparison to Predicate Devices: 7.

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Annual Property of Children Commenssion in Children of Children to ChildrenBattery life	Running 1,000 test	Running 1,000 test
		Acres of the research division for the------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

	Differences
Item	Subject Device(s)	Predicate Device(s)
	Rightest BGMS GM100(AST)	Rightest BGMS(AST)
Description andLabelling	We mention theinformation aboutmodification in user'sInstruction. We also showa diagrammaticexplanation aboutalternative test sites inuser's Instruction.	We mention theinformation aboutmodification in user'smanual. We also show adiagrammatic explanationabout alternative test sitesin user's manual.
CodingInterference	No coding	Code keyUric acid > 9.0 mg/dLL-Doga > 1.5 ml/dLMethyldopa > 1.5 mg/dLCholesterol > 250 mg/dL
Memory Capacity	10 blood glucose testresults with date and time	300 blood glucose testresults with date and time
Power Saving	Turn off automatically after2 minutes	Turn off automatically after3 minutes
Power Supply	One CR2032 battery	Two 1.5V(AAA) batteries

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

Verification and validation of test results were evaluated to establish the performance, functionality and reliability of The Rightest Blood Glucose Monitoring System.

The evaluation included precision, linearity, interference, hematocrit and control solution.

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

Test capillary blood Study:

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

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Technician	Rightest fingerstick vsOlympus-Plasma	Rightest palmstick vsOlympus-Plasma	Rightest armstick vsOlympus-Plasma
Test range (mg/dL)	35~568	34~542	39~572
Test number	164	164	164
Slope	0.99	0.96	0.96
Intercept	0.74	6.35	0.46
r	0.993	0.990	0.987

Fig 1 J inear regression from Rightest versus Olympus AU2700
--------------------------------------------------------------	--	--

The "Alternative Site Test" clinical evaluation shows substantial equivalence to Rightest used in finger, palm and arm position. They all have similar slope and intercept of Rightest value versus Olympus AU2700. So the result tells us Rightest blood glucose monitoring system, model GM100 is suitable to be used in fingertip, palm and forearm.

10. Conclusions:

Results of clinical testing demonstrate that the performance of the Rightest Blood Glucose Monitoring System, model GM100 testing capillary whole blood is substantial equivalence of Rightest Blood Glucose Monitoring System (AST). The precision and accuracy of Rightest is suitable for its in monitoring the effectiveness of diabetes management at home and in clinical settings.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle faces right. Encircling the eagle is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 1 8 2008

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

Re: K081451

Trade Name: Rightest Blood Glucose Monitoring System, Model GM100 Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Codes: NBW, CGA Dated: August 15, 2008 Received: August 18, 2008

Dear Ms. Goldstein-Falk:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Yéan M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K081451

Device Name: Rightest Blood Glucose Monitoring System, Model GM100

Indications For Use:

The Rightest Blood Glucose Monitoring System is intended for in vitro diagnostic use (outside of body). It is indicated to be used by professional healthcare personnel or diabetics at home to measure the glucose concentration for aiding diabetes management. The glucose concentration is measured with quantitative capillary whole blood from the fingertip, palm, and forearm by using Rightest Blood Glucose Monitoring System. This device is not intended for testing neonate blood samples.

Special conditions for use statement(s): Rightest System provides plasma equivalent results.

Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Ann Chappie
Division Sign-Off

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)________________________________________________________________________________________________________________________________________________________________________

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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.