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 an analysis of the provided text to extract the acceptance criteria and study details:

Acceptance Criteria and Device Performance

The document does not explicitly state formal "acceptance criteria" in a typical numerical or statistical format (e.g., all results within X% of reference). Instead, it relies on demonstrating substantial equivalence to a predicate device and showing suitable performance through linear regression parameters. The primary performance metric presented is the linear relationship between the device's readings and a reference method (Olympus AU2700).

Table of Performance for Rightest Blood Glucose Monitoring System, Model GM110

Test Site	Reference Test Range (mg/dL)	Number of Tests	Slope	Intercept	Correlation Coefficient (r)
Fingerstick	35-586	164	0.98	2.13	0.991
Palmstick	35-589	164	0.96	9.80	0.990
Armstick	35-566	164	0.95	2.82	0.990

Interpretation of "Acceptance Criteria": The reported performance, particularly the high correlation coefficients (r > 0.99), slopes close to 1, and small intercepts demonstrate a strong linear relationship and agreement with the reference method across various alternative testing sites. This performance is implicitly presented as meeting the substantial equivalence requirements for a glucose monitoring system. The text states: "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 GM110 is suitable to be used in fingertip, palm and forearm."

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: 164 tests for each alternative site (fingerstick, palmstick, armstick).
- Data Provenance: Not explicitly stated regarding country of origin. The study is described as "Clinical Tests Performed," implying prospective data collection for the purpose of the submission. The submitter is BIONIME CORPORATION NO 694, RENHUA ROAD, DALI CITY, TAICHUNG COUNTY, TAIWAN.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. The ground truth was established using a clinical chemistry analyzer (Olympus AU2700) rather than expert consensus on images or clinical assessments.
Adjudication method for the test set:
- Not applicable/Not provided. Adjudication methods like 2+1 or 3+1 are typically used for assessing qualitative or subjective outcomes, often in imaging studies. For quantitative measurements like blood glucose, a reference standard instrument is used, and the device's readings are compared directly to it.
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:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI systems assisting human interpretation, particularly in diagnostic imaging. This submission concerns a quantitative blood glucose monitoring device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, the study describes the standalone performance of the Rightest Blood Glucose Monitoring System. The results provided (slope, intercept, r-value) directly reflect the device's accuracy against a reference method. It's a "device only" performance evaluation.
The type of ground truth used:
- Reference Standard: The ground truth was established by comparing the device's readings to measurements from an Olympus AU2700 clinical chemistry analyzer (referred to as "Olympus-Plasma"). This is a recognized laboratory reference method for blood glucose measurement.
The sample size for the training set:
- Not applicable/Not provided. This device is a traditional electro-chemical blood glucose meter, not an AI/machine learning algorithm that requires a separate training set. The performance is based on the inherent physical and chemical properties of the system (meter and test strips).
How the ground truth for the training set was established:
- Not applicable. As noted above, there is no "training set" in the context of an AI/ML algorithm.

Summary

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Exhibit 1

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: 881450

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

Date Summary Prepared: July 13, 2007

Name of the Device: Rightest Blood Glucose Monitoring System, Model GM110 2.
1. Common or Usual Name: Glucose test system Panel: Clinical Chemistry 75 Product Code: NBW, System, Test, Blood Glucose, Over-the-Counter. Classification: Class II
1. Device Description:

1. Intended 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 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.

1. Predicate Device Information:
  The Rightest Blood Glucose Monitoring System, model GM110 is substantially equivalent to the brand of Rightest Blood Glucose Monitoring System (Alternative Site Testing) noted below.

Rightest Blood Glucose Monitoring System, model GM110 Name: Device Company: Bionime Corporation 510(K) Number: K042678, K053635 and K062567

Comparison to Predicate Devices:	НИНИЕ В А ПРИВИНИЯ НА ВИНИНИИ В МИНИНИИ В ИНИНИНИЕ В НАС ПРОДОДЕЛА НА СЕДА С
		Comments of the American Comments of

Similarities
Item	Subject Device	Predicate Device(s)
	Rightest BGMS GM110(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

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Battery life	Running 1,000 test	Running 1,000 test

Differences
Item	Subject Device(s)	Predicate Device(s)
	Rightest BGMS GM110(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	Code SelectionUric acid > 9.0 mg/dLCholesterol > 500 mg/dL	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

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

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

The evaluation included precision, linearity, interference, 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)	35~586	35~589	35~566
Test number	164	164	164
Slope	0.98	0.96	0.95
Intercept	2.13	9.80	2.82
r	0.991	0.990	0.990

Fig 1 Linear 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 GM110 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 GM110 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

DEPARTMENT OF HEALTH & HUMAN SERVICES - USA

Food and Druq Administration 2098 Gaither Road Rockville MD 20850

SEP 1 1 2008

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

Rc: K081450

Trade Name: Rightest Blood Glucose Monitoring System, Model GM110 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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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.

Yean 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):

Device Name: Rightest Blood Glucose Monitoring System, Model GM110

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)

Carol C Benson
Division Sign-Off

Division Sign-O

Office of In Vitro Diagnostic Device Evaluation and Safety

K081450

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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.