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 using capillary whole blood from the fingertip by using Rightest Blood Glucose Monitoring System.

This test device is not intended for testing neonate blood samples.

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

Device Description

Our Blood Glucose Monitoring System includes Meter, Blood Glucose Test Strips, Code Kev. Check key, One Control Solution, Lancing Device and lancets. Rightest meter, Blood Glucose Test Strips, Code Key and Check key are manufactured by BIONIME Corporation. The Rightest Meter, when used with the Rightest Blood Glucose Test Strips, quantitatively measures glucose in fresh capillary whole blood.

The performance of the Rightest Blood Glucose Test Strips is verified by Control Solution. The Check key verifies the status of Rightest meter.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Rightest Blood Glucose Monitoring System, based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria in a dedicated section with pass/fail values. However, the reported performance metrics from the clinical studies serve as the basis for demonstrating equivalence and suitability for its intended use. The implicit acceptance criterion appears to be strong correlation and agreement with a reference method/technician.

Performance Metric	Acceptance Criteria (Implicit, based on intended use and predicate)	Reported Device Performance (Rightest Blood Glucose Monitoring System)
Consumer Study (Lay User vs. Technician)	Strong linear correlation (slope near 1, intercept near 0, high R value) to technician measurements for capillary whole blood.	Capillary whole blood (n=128):- Slope: 1.0066- Intercept: -0.576- R: 0.9959
Point of Care Study (Rightest vs. YSI 2300D)	Strong linear correlation (slope near 1, intercept near 0, high R value) to the YSI 2300D Glucose Analyzer.	Capillary Whole Blood (n=309):- Slope: 1.0025- Intercept: 4.509- R: 0.9886Venous Whole Blood (n=309):- Slope: 1.1806- Intercept: -1.362- R: 0.9873Venous Plasma (n=309):- Slope: 1.819- Intercept: 2.280- R: 0.9980
Testing Range	Equivalent to predicate (20 - 600 mg/dL) and sufficient for clinical management.	Consumer Study: 56.0 - 556 mg/dLPoint of Care Study: 68.0 - 565 mg/dL

Study Details

Sample sizes used for the test set and the data provenance:
- Consumer Study (Field Test):
  - Sample Size: 128 patients.
  - Data Provenance: Not explicitly stated, but clinical testing typically originates from the location of the submitting company or its contractors. Given the submitter's identification as BIONIME CORPORATION in Taiwan, it's highly probable the data is from Taiwan. The study is prospective in nature, as it involves active testing with the device.
- Point of Care Study:
  - Sample Size: 309 blood samples.
  - Data Provenance: Not explicitly stated regarding country, but performed in "the same general hospital," implying a prospective study. Again, likely from Taiwan.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Consumer Study: Ground truth was established by "technician" measurements. The specific number of technicians and their qualifications (e.g., years of experience, specific certifications) are not specified in the summary.
- Point of Care Study: The ground truth was established by the YSI 2300D glucose analyzer. This is an automated reference instrument, not human experts, so the concept of "number of experts" is not applicable here.
Adjudication method for the test set:
- Not applicable or Not specified. The studies compare the device's measurements directly to a reference (technician or YSI 2300D), rather than having multiple human readers interpret results that then require adjudication.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This is a blood glucose monitoring system, and the studies focused on the accuracy of the device's quantitative measurements compared to reference methods, not on human interpretation or decision-making aided by AI.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, the clinical studies presented, particularly the "Point of Care Study" comparing the Rightest Blood Glucose Monitoring System directly to the YSI 2300D glucose analyzer, demonstrate the standalone performance of the device (i.e., the algorithm/system's ability to measure glucose). While a "consumer study" also involved lay users, the comparison was to "technician" measurements, still fundamentally assessing the device's standalone accuracy when used by different operators.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Consumer Study: "Technician" measurements (implied to be highly accurate laboratory or clinical measurements). This leans towards expert-performed reference measurements.
- Point of Care Study: YSI 2300D glucose analyzer measurements. This is considered a gold standard reference instrument for glucose measurement.
The sample size for the training set:
- Not specified. The summary only provides details on the clinical validation/test sets, not on any internal training sets used during the development of the device's algorithms or calibration. For blood glucose meters, "training" often refers to development of calibration curves and algorithms using a large number of samples, but these details are not typically included in 510(k) summaries for such devices unless it's a novel machine learning algorithm requiring specific training data disclosure.
How the ground truth for the training set was established:
- Not specified. As the training set size and details are not provided, neither is how its ground truth was established.

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:_ 1042678

Submitter's Identification: 1.

BIONIME CORPORATION NO 694, RENHUA ROAD, DALI CITY, TAICHUNG COUNTY, TAIWAN 412 Contact Person: Patrick Hsieh Phone Number: 886-4-24951268 FAX Number: 886-4-24952568

Date Summary Prepared: September 28, 2004.

Name of the Device: Rightest Blood Glucose Monitoring System 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

4. Device Description:

The performance of the Rightest Blood Glucose Test Strips is verified by Control Solution. The Check key verifies the status of Rightest meter.

5. 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 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 by using Rightest Blood Glucose Monitoring System.

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This device is not intended for testing neonate blood samples.

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

Predicate Device Information: 6.

The Rightest Blood Glucose Monitoring System is substantially equivalent to the brand of ONE TOUCH Ultra noted below.

ONE TOUCH® Ultra® Blood Glucose Monitoring System Name: Device Company: Lifescan, Inc. 510(K) Number: K024194

Comparison to the Predicate Device: 7.

Similarities
Item	DeviceRightest	PredicateONE TOUCH® Ultra®
Detectionmethod	Amperometry	Amperometry
Enzyme	Glucose Oxidase(Aspergillus niger)	Glucose Oxidase(Aspergillus niger)
Mediator	Potassium ferricyanide	Potassium ferricyanide
Test range	20 - 600 mg/dL	20 - 600 mg/ dL
HematocritRange	30 – 55%	30 - 55%
Temperaturerange	50 - 104° F10 - 40° C	43 - 111° F6 - 44° C
Humidity range	10 - 90%	10 - 90%
Warranty(meter)	3 years	3 years
Open use time(strip)	3 months	3 months
Differences
Item	DeviceRightest	PredicateONE TOUCH® ULTRA®
Electrode	Noble metal electrode	Carbon electrode
Coding	Code key	Button (C1 - C49)
Test Time	15 seconds	5 seconds
Sample Volume	2 uL	1 uL
Memorycapability	3, 7, 14 day average andlast 200 tests in thememory	14-day average and last150 tests in the memory
Power	$1.5V\times2$ battery (LR03)	3V Li battery (CR2032)
Battery life	Running 1,500 test	Running 1,000 test
Size: LxWxH	85.0x58.0x22.5	79x57x21

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(mm)
Weight	85g (with battery)	42g (with battery)

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

Verification and validation of test results were evaluated to establish the verformance, functionality and reliability of The Rightest Blood Glucose Monitoring System. Testing included precision testing, linearity testing, sensitivity testing, interference testing, stability testing and electrical/EMC testing.

Discussion of Clinical Tests Performed: 9.

Clinical testing included a consumer study and point of care study as outlined below:

Consumer Study (field test):

Linear regression was established between lay user (Y axial) and technician (X axial).

Blood type	Capillary whole blood
Patient number	128
Testing range	56.0~556 mg/dL
Slope	1.0066
Intercept	-0.576
R	0.9959

Point Of Care Study:

I officer correlation between the YSI 2300D glucose analyzer (X axial) and Rightest Blood Glucose Monitoring System (Y axial) were confirmed in the 309 blood samples. Results obtained by 3 positions in the same general hospital presented the following regression:

Blood type	Capillary WholeBlood	Venous WholeBlood	Venous Plasma
Patient number		309
Testing range		68.0 ~ 565 mg/dL
Slope	1.0025	1.1806	1.819
Intercept	4.509	-1.362	2.280
R	0.9886	0.9873	0.9980

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10. Conclusions:

Results of evaluation and clinical testing demonstrate that the performance of the Rightest Blood Glucose Monitoring System testing capillary whole blood is substantially equivalent to the predicate device, ONE TOUCH® Ultra® Blood Glucose Monitoring System. The precision and accuracy of Rightest is suitable for its use 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 seal of the Department of Health & Human Services-USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or other bird in flight. The symbol is composed of three curved lines that suggest the wings and body of the bird.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN - 3 2005

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

K042678 Re:

Trade/Device Name: Rightest Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA, JJX Dated: December 17, 2004 Received: December 20, 2004

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)276-0484. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours.

Patricia Bernhart
for C. Rooks

Cornelia B. Rooks, MA Acting 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

Indications For Use:

This test device is not intended for testing neonate blood samples.

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

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

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

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

Division Signer of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Office of In Vitro Diagnostic Device Evaluation and Safety

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510(k) K042678

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.