The Rightest Control Solutions GC300 are for use with the Rightest Blood Glucose Meter GM300 and the Rightest Blood Glucose Test Strip GS300 to check that the meter and test strips are working together properly and that the test is performing correctly.

The Rightest Control Solutions GC100 are for use with the Rightest Blood Glucose Meter GM100 and the Rightest Blood Glucose Test Strip GS100 to check that the meter and test strips are working together properly and that the test is performing correctly.

The Rightest Control Solutions GC110 are for use with the Rightest Blood Glucose Meter GM110 and the Rightest Blood Glucose Test Strip GS300 to check that the meter and test strips are working together properly and that the test is performing correctly.

The Rightest Control Solutions GC310 are for use with the Rightest Blood Glucose Meter GM310 and the Rightest Blood Glucose Test Strip GS310 to check that the meter and test strips are working together properly and that the test is performing correctly.

Device Description

Rightest Control Solution is a single-level, aqueous liquid qlucose control solution containing a measured amount of qlucose that reacts with the test strips to provide a Quality Control Result. This result should fall within the expected range printed on the Test Strip vial, and will verify if the meter and the test strips are working properly. The Rightest Control Solution has a red color to help users see the solution while dispensing onto a test strip.

Rightest Control Solution is a non-hazardous aqueous glucose control solution containing no human or animal derived materials.

AI/ML Overview

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

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Value Assignment Procedure:	Met:
- Data from repeated measurement evaluated by ANOVA analysis.	- "Data from repeated measurement will first be evaluated by ANOVA analysis." (Implied met, as study proceeded to determine mean/CV).
- Acceptable range of measurement: ±15% of Mean value.	- "Only after passing the ANOVA analysis, the data from repeated measurement can proceed to determine mean/CV to establish an acceptable range. The acceptable range of measurement as ±15% of Mean value to correspond to the value assignment ranges currently provided by using Rightest test strips. The test result should fall within the expected range printed on the Test Strip vial, and will verify if the meter and the test strips are working properly." (Implied met, as the acceptable range was established and the conclusion states performance was demonstrated.)
Closed Bottle Stability (Shelf-Life):	Met:
- 1.5 years (18 months) at 2-30°C.	- "Stability characteristics were determined under unopened conditions in real time and accelerated stability studies to demonstrate an closed shelf-life of 1.5 years (18 months) at the recommended storage temperatures, ranging from 2-30°C (36-86°F)."
Opened Bottle Stability (Open-Vial):	Met:
- 3 months (20 weeks) with less than 10% bias of week 0 values.	- "Rightest Control Solution meets stability requirements in real-time stability study as demonstrated by less than 10% bias of week 0 values with an open-vial claim of 3 months (20 weeks)."

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

Sample Size for Value Assignment: Total of 30 measurements for each test strip type. This was derived from using three lots of control solutions and ten blood glucose meters.
Data Provenance: The document does not explicitly state the country of origin for the data for the value assignment study. However, the submitter's identification is "BIONIME CORPORATION NO 694, RENHUA ROAD, DALI DIST., TAICHUNG CITY, TAIWAN 412," suggesting the studies were likely conducted in Taiwan. The studies were prospective as per the description of the testing procedures (e.g., stability studies involving real-time measurements).

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

This device is a control solution for blood glucose meters, not a diagnostic device that requires human interpretation of images or complex data. Therefore, the concept of "experts establishing ground truth" in the traditional sense (e.g., radiologists) does not apply.

Instead, the "ground truth" or reference values are established through a statistical process of repeated measurements using the meters and test strips designed to work with the control solution, and then defining an acceptable deviation (±15% of the mean). The expertise involved would be in the design and execution of these analytical studies and the interpretation of statistical results, rather than clinical consensus.

4. Adjudication Method for the Test Set

Not applicable. As described above, the "ground truth" for this type of device is established through an analytical and statistical process involving repeated measurements, ANOVA analysis, and establishing a mean and acceptable range (±15% of the mean). There is no mention of human adjudication for individual test results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret cases, and the AI's role is to assist or augment that interpretation. This submission is for a control solution, an in-vitro diagnostic (IVD) analytical reagent, which verifies the proper functioning of a blood glucose monitoring system, not for a device that involves human interpretation of medical cases.

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

The device is a control solution, not an algorithm or AI. Therefore, the concept of a "standalone algorithm performance" study is not applicable. The performance evaluated is the ability of the control solution to produce results within a defined range when used with the specified blood glucose meters and test strips.

7. The Type of Ground Truth Used

The ground truth used for establishing the acceptable ranges of the control solution is based on an analytical reference method where:

Repeated measurements of the control solution are taken using multiple test strips and meters.
Statistical analysis (ANOVA) is applied to these measurements.
A mean value is determined, and an acceptable range is established as ±15% of that mean value.

This is effectively an empirical, statistically derived ground truth based on the expected performance characteristics of the glucose monitoring system components (meters and test strips) when reacting with the control solution.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI, as the device is not an algorithm. However, if we interpret "training set" as the data used to establish the reference values or expected performance of the control solution:

For the value assignment procedure: The data used consisted of measurements from three lots of control solutions and ten different blood glucose meters for each test strip type. This provided 30 measurements for each test strip type. This data was used to establish the mean and acceptable ranges.
For stability studies: The document states "real time and accelerated stability studies" were conducted, implying ongoing monitoring over time, which would involve a dataset gathered over the stability period. Specific sample sizes for these continuous measurements are not provided beyond the general description.

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

As noted above, for the value assignment, the ground truth was established through a rigorous analytical characterization process:

Repeated measurement: The control solution was repeatedly tested using a defined set of meters and test strips.
ANOVA analysis: Statistical analysis (ANOVA) was performed to evaluate the data from these repeated measurements, likely to ensure consistency across lots and meters.
Mean and acceptable range determination: After passing ANOVA, the data was used to calculate a mean value. This mean then formed the basis for the "ground truth" reference range, with an acceptable deviation defined as ±15% of the mean value. This range corresponds to existing assigned values for the Rightest test strips.

This process ensures that the control solution's expected readings are consistent with the established performance specifications of the blood glucose monitoring system it is intended to verify.

Summary

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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: K133003

Submitter's Identification: 1.

BIONIME CORPORATION NO 694, RENHUA ROAD, DALI DIST., TAICHUNG CITY, TAIWAN 412 Contact Person: Mr. Rov Huang Phone Number: 886-4-23692388 FAX Number: 886-4-22617568

Date Summary Prepared: September 23, 2013

OCT 2 4 2013

1. Name of the Device: Rightest Control Solution GC300 Rightest Control Solution GC310 Rightest Control Solution GC100 Rightest Control Solution GC110
Common or Usual Name: Control Solution 3.

Product Code	Classification	RegulationSection	Panel
JJX, Single (Specified)Analyte Controls(Assayed andUnassayed)	Class I,reserved	21 CFR862.1660	Clinical Chemistry75

4. Device Description:

Rightest Control Solution is a non-hazardous aqueous glucose control solution containing no human or animal derived materials.

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5. Intended Use:

6. Predicate Device Information:

The Rightest Control Solution GC300, GC310, GC100, GC110 are substantially equivalent to the predicate device noted below.

Rightest Control Solution GC700 Name: Device Company: Bionime Corporation 510(K) Number: K110737

7. Comparison to Predicate Devices:

Comparison of similarities and differences:

Item	New DeviceRightest Control Solution,GC300, GC310, GC100, GC110	Predicate DeviceRightest Control SolutionGC700 (K110737)
Similarities
Intended use	Quality control material to checkthat the meter and test strips areworking properly and that thetest is performing correctly	Same

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Stability (shelf life)	1.5 years	Same
Stability (open-vial)	3 months	Same
Analyte	glucose	Same
Color	Red	Same
Net fill	4 mL	Same
Differences
Levels	One	Five
Target range	Level 2 (64-120 mg/dL)(range of midpoint assigned values with various BGMS)	Level 1 (44-66 mg/dL)Level 2(83-123 mg/dL)Level 3(163-243 mg/dL)Level 4(231-345 mg/dL)Level 5(351-525 mg/dL)(range of midpoint assigned values with various BGMS)

Technological characteristics of the device: 8.

Rightest Control Solution consists of water, d-glucose, inorganic salt, dye and preservative and has been optimized to simulate the response of whole blood on the Rightest Blood Glucose Monitoring Systems. The design and chemical composition is similar to the predicate device. The control solution contains no hazardous, human or animal derived material.

Summary of non-clinical tests submitted with the premarket notification for the 9. device:

Tests were conducted to verify specific performance requirements:

a) Value assignment procedure:
Total three lots of control solutions and ten blood glucose meters were evaluated for each test strip type, providing 30 measurements of Rightest Control Solution on each test strip type.

Data from repeated measurement will first be evaluated by ANOVA analysis. Only after passing the ANOVA analysis, the data from repeated measurement can proceed to determine mean/CV to establish an acceptable range. The acceptable range of measurement as ±15% of Mean value to correspond to the value assignment ranges currently provided by using Rightest test strips. The test result should fall within the expected range printed on the Test Strip vial, and will verify if the meter and the test strips are working properly.

b) Closed bottle Stability:
Stability characteristics were determined under unopened conditions in real time and accelerated stability studies to demonstrate an closed shelf-life of 1.5

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years (18 months) at the recommended storage temperatures, ranging from 2-30°C (36-86°F).

Opened bottle Stability:

Rightest Control Solution meets stability requirements in real-time stability study as demonstrated by less than 10% bias of week 0 values with an openvial claim of 3 months (20 weeks).

10. Conclusions:

Results of performance evaluation of the Rightest Control Solution GC300, the Rightest Control Solution GC100, the Rightest Control Solution GC110, and the Rightest Control Solution GC310 demonstrate that the devise is substantial equivalence to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

October 24, 2013

BIONIME CORPORATION c/o Jigar Shah MDI Consultants, Inc. 55 Northern Blvd. Suite 200 GREAT NECK NY 11021

Re: K133003

Trade/Device Name: Rightest Control Solution GC300 Rightest Control Solution GC310 Rightest Control Solution GC100 Rightest Control Solution GC110 Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: I, reserved Product Code: JJX Dated: September 23, 2013 Received: September 25, 2013

Dear Jigar Shah:

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

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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 regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance 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" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Carol Benson -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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Indications for Use

510(k) Number (if known): K133003

Device Name: Rightest Control Solution GC300

Indications For Use:

Prescription Use x 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 Diagnostics and Radiological Health (OlR)

Stayce Beck

______________________________________________________________________________________________________________________________________________________________________________ Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k)________________________________________________________________________________________________________________________________________________________________________

Page 1 of __ 4__

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BIONIME

Indications for Use

510(k) Number (if known): K133003

Device Name: Rightest Control Solution GC100

Indications For Use:

Prescription Use x 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 Diagnostics and Radiological Health (OIR)

Staycee@Beck

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k)________________________________________________________________________________________________________________________________________________________________________

Page 2 of __ 4 __

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BIONIME

Indications for Use

510(k) Number (if known): K133003

Device Name: Rightest Control Solution GC110

Indications For Use:

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 Diagnostics and Radiological Health (OIR)

Stayce Beck

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k)________________________________________________________________________________________________________________________________________________________________________

Page 3 of 4

Indications for Use

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BIONIME

510(k) Number (if known): K 133003

Device Name: Rightest Control Solution GC310

Indications For Use:

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 Diagnostics and Radiological Health (OIR)

Stayce/Beck

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health,

510(k) 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 -

Page 4 of __ 4

Regulation Number and Section

§ 862.1660 Quality control material (assayed and unassayed).

(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.