The GE Blood Glucose Monitoring System 333 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 GE Blood Glucose Monitoring System 333 is intended to be used by a single person and should not be shared.

The GE Blood Glucose Monitoring System 333 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 GE Blood Glucose Monitoring System 333 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 GE Blood Glucose Test Strips 33 are for use with the GE Blood Glucose Meter 333 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

Device Description

The GE Blood Glucose Monitoring System 333 consists of the following devices: GE Blood Glucose Meter 333, GE Blood Glucose Test Strip 333, and Rightest Control Solution GC550. The GE333 Blood Glucose Meter and GE Blood Glucose Test Strips 333 are manufactured by BIONIME Corporation. The GE Blood Glucose Meter 333, when used with the GE Blood Glucose Test Strips 333, quantitatively measures glucose in fresh capillary whole blood. The performance of the GE Blood Glucose Monitoring System 333 is verified by the Rightest Control Solution GC550.

The Rightest Control Solution GC550 has been previously been cleared (K092052) and is being repackage for use with the GE Blood Glucose Monitoring System 333.

GE Blood Glucose Test Strip 333 paired with GE Blood Glucose Meter 333 that utilizes electrical characteristic technology for measuring the glucose level in human blood. A relatively small drop of blood (minimum requirement of only 0.75 µL) is placed on the disposable GE Test Strip 333 coated with Glucose Oxidase which interacts with the GE Blood Glucose Meter 333. Within 5 seconds after testing, the blood glucose level is indicated on the meter's digital display screen.

AI/ML Overview

This document describes K143387, for the GE Blood Glucose Monitoring System 333, which is substantially equivalent to the Rightest Blood Glucose Monitoring System GM550.

Here's an analysis of the acceptance criteria and the studies performed:

1. Table of Acceptance Criteria and Reported Device Performance

The document frequently refers to "acceptance criteria" but does not explicitly list them in a single table with associated performance statistics. Instead, the performance is reported against implicit or general criteria (e.g., "falls within the acceptance criteria," "within the criteria of ±15%," "met the acceptance criteria").

Below is a table summarizing the performance evaluation where acceptance criteria are discernable from the text:

Study/Test	Acceptance Criteria (Implied)	Reported Device Performance
Linearity	Linear regression mean slopes above 0.99, R2 values above 0.99	Linear regression between device and reference method shows mean slopes above 0.9912 and R2 values above 0.999. Glucose assay is linear from 20-600 mg/dL.
Precision (Repeatability)	Falling within defined acceptance criteria (not explicitly stated numerically)	Repeatability evaluation results demonstrate that repeatability falls within the acceptance criteria.
Precision (Intermediate)	Falling within defined acceptance criteria (not explicitly stated numerically)	Intermediate precision evaluation results demonstrate that intermediate precision falls within the acceptance criteria.
Sample Volume (Minimum)	Less than 0.60 µL should display an error message (Er4); other volumes within ±10% bias compared to reference	When sample volumes were less than 0.60 µL, meter displayed error message (Er4). At all other sample volumes (greater than 0.65 µL), the results were within the accepted criteria of ±10% bias compared to reference. Minimum sample volume determined to be 0.75 µL.
Interference	Percentage of interference within ±10% bias (as implied by the report)	Ascorbic acid (≥ 5 mg/dL), cholesterol (600 mg/dL), and uric acid (≥ 10 mg/dL) indicated percentage of interference over ±10% bias in high glucose concentration (leading to limitations statement). The remaining 16 interference substances were within the criteria for normal and high glucose concentrations.
Hematocrit	Stability compared to reference method within ±15% of reference value	Stability compared to the reference method during various HCT ranges were all within the criteria of ±15% of reference value. The acceptable HCT range is 20-60%.
System Accuracy	Meets acceptance criteria and EGA (Error Grid Analysis) for clinical performance, no significant difference in slope, intercept, and correlation coefficient between subject device and comparative meter/reference lab instrument.	The accuracy of subject device met the acceptance criteria, and there was no significant difference in slope, intercept, and correlation coefficient between the comparative meter or reference lab instrument.
User Performance	Achieves accurate results such that it is substantially equivalent to predicate device	The study result shows substantial equivalence to predicate device used in finger, palm and forearm position for accurate results by lay users.

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

Linearity: 15 levels of glucose concentrations. (Specific number of samples per level not stated). Data provenance is likely internal lab testing ("Venous blood samples spiked").
Precision (Repeatability): 1500 test strips used (over 10 days, 5 glucose concentrations, 10 meters, 3 lots). Data provenance is internal lab testing ("venous blood sample results").
Precision (Intermediate): 900 test strips used (over 10 days, 3 glucose concentrations, 10 meters, 3 lots). Data provenance is internal lab testing ("venous blood sample results").
Sample Volume: 9 sample volumes (ranging from 0.60 to 3.0 µL), 3 lots of strips, 3 glucose concentration levels. Data provenance is internal lab testing ("Venous blood").
Interference Study: 3 lots of test strips, 2 glucose concentration levels, 19 interference substances. Data provenance is internal lab testing ("venous blood samples").
Hematocrit Study: 3 lots of blood glucose test strips, 6 glucose concentration levels, tested in 5 replicates. Data provenance is internal lab testing ("venous blood samples").
System Accuracy Study: 103 patients participated. Data provenance is clinical study ("capillary whole blood obtained from fingertip, palm, and/or forearm"). The location (country) is not specified, but typically these studies are either internal to the company's location (Taiwan) or a contract research organization. It does not state if it was retrospective or prospective, but clinical accuracy studies are generally prospective.
User Performance Study: 160 laypersons in multiple sites. Data provenance is a clinical study ("capillary whole blood from fingertip, palm and forearm sample sites"). The location (country) is not specified. It does not state if it was retrospective or prospective, but user performance studies are generally prospective.

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

For the non-clinical studies (Linearity, Precision, Sample Volume, Interference, Hematocrit), the ground truth was established by the YSI 2300 Plus Glucose Analyzer (or YSI 2300 Analyzer), which is a laboratory reference method. Therefore, human experts were not directly establishing the ground truth for these measurements; rather, it was established by a recognized gold standard instrument. Expert qualifications for operating and maintaining such instruments are implied but not stated.

For the System Accuracy Study, the ground truth was established by the YSI 2300 Plus Glucose Analyzer. A comparative effectiveness was also done against a reference device, the Roche ACCU-CHEK Performa. Human experts were involved in collecting samples and running the analyzers but not in establishing the ground truth value itself, which came from the YSI machine.

For the User Performance Study, the primary ground truth reference is the subject device's own performance against its predicate (implying the predicate device's established accuracy as a baseline for "accurate results"). However, in clinical studies like this, a lab reference method (like YSI) would typically be used to compare both the user's results and potentially results from trained personnel. The document does not explicitly state how ground truth was established for the user performance aspect, beyond showing substantial equivalence to the predicate.

4. Adjudication Method for the Test Set

Not applicable. For the analytical studies, the ground truth was established by an automated laboratory reference instrument (YSI 2300 Plus Glucose Analyzer). For the clinical studies, no "adjudication" between multiple human readers is mentioned, as the primary ground truth was instrumental or comparison to a predicate.

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

No, an MRMC comparative effectiveness study in the context of human readers improving with AI vs. without AI assistance was not performed. This device is a blood glucose monitoring system, not an AI-powered diagnostic imaging tool requiring human interpretation.

A System Accuracy Study was performed comparing the device to a reference method (YSI 2300 Plus Glucose Analyzer) and a comparative meter (Roche ACCU-CHEK Performa). This is a comparative study but not an MRMC study involving human readers and AI assistance.

A User Performance Study involved lay users, effectively acting as "multiple readers" for the device, but it was to demonstrate the device's usability and accuracy by laypersons, not to assess an AI's impact on human reader performance.

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

Yes, the analytical performance studies (Linearity, Precision, Sample Volume, Interference, Hematocrit) and the System Accuracy Study are essentially standalone performance evaluations of the device (meter and test strips) against a laboratory reference standard. These studies assess the algorithm's ability to accurately measure glucose without direct human interpretive intervention beyond operating the device and reference method. The device itself is an algorithm-driven measurement tool.

7. The Type of Ground Truth Used

For non-clinical analytical studies (Linearity, Precision, Sample Volume, Interference, Hematocrit) and the System Accuracy Study, the ground truth was established by a laboratory reference method: YSI 2300 Plus Glucose Analyzer.

For the User Performance Study, the ground truth was implied by the established accuracy of the predicate device and the reference method used in other studies, to determine if lay users could obtain "accurate results."

8. The Sample Size for the Training Set

The document does not specify a training set size. Blood glucose monitoring systems typically do not involve machine learning models that require distinct "training sets" in the same way AI/ML algorithms for image analysis do. Instead, the device's design, calibration, and internal algorithms are developed and validated using extensive lab testing and engineering principles. The studies described are primarily for verification and validation of the final product's performance and accuracy.

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

As no specific training set for a machine learning model is mentioned, this question is not directly applicable. The device's underlying technology relies on electrochemical reactions and calibration curves established through rigorous laboratory testing using reference methods like the YSI 2300 Plus Glucose Analyzer, rather than a "training set" in the context of AI.

Summary

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

June 3, 2015

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

Re: K143387

Trade/Device Name: GE Blood Glucose Monitoring System 333 Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW. CGA Dated: May 4, 2015 Received: May 6, 2015

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/Resourcesfor You/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

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name

GE Blood Glucose Monitoring System 333

Indications for Use (Describe)

The GE Blood Glucose Monitoring System 33 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 GE Blood Glucose Monitoring System 333 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).

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)

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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: K143387

1. Submitter's Identification:
  BIONIME CORPORRATION NO 100, Sec. 2, Daqing St., South Dist., 40242 Taichung City, Taiwan

Phone Number: 886-4-23692388 FAX Number: 886-4-22617568

c/o IVDD Regulatory Consultant 29222 Rancho Viejo Road, Suite 218 San Juan Capistrano, CA 92675 Contact Person: Feng-Yu Lee Phone Number: 1-949-218-0929 Fax Number: 1-949-218-0928

Date Summary Prepared: May 29, 2015

1. Name of the Device: GE Blood Glucose Monitoring System 333
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
CGA; Glucose Oxidase,Glucose	Class II	21 CFR 862.1345	Clinical Chemistry 75

4. Device Description:

4.1 The GE Blood Glucose Monitoring System 333 consists of the following devices: GE Blood Glucose Meter 333, GE Blood Glucose Test Strip 333, and Rightest Control Solution GC550. The GE333 Blood Glucose Meter and GE Blood Glucose Test Strips 333 are manufactured by BIONIME Corporation. The GE Blood Glucose Meter 333, when used with the GE Blood Glucose Test Strips 333, quantitatively measures glucose in fresh capillary whole blood. The performance of the GE Blood Glucose Monitoring System 333 is verified by the Rightest Control Solution GC550.

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The Rightest Control Solution GC550 has been previously been cleared (K092052) and is being repackage for use with the GE Blood Glucose Monitoring System 333.

న. Intended Use:
The GE Blood Glucose Monitoring System 333 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 GE Blood Glucose Monitoring System 333 is intended to be used by a single person and should not be shared.

The GE Blood Glucose Test Strips 333 are for use with the GE Blood Glucose Meter 333 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

6. Predicate Device Information:

The GE Blood Glucose Monitoring System 333 is substantially equivalent to the Rightest Blood Glucose Monitoring System noted below.

Name:	Rightest Blood Glucose Monitoring System GM550
Device Company:	Bionime Corporation
510(K) Number:	K092052
Name:	Rightest Blood Glucose Monitoring System GM550
Name:	Rightest Blood Glucose Test Strips GS550
Name:	Rightest Blood Glucose Control Solution GC550
Device Company:	Bionime Corporation

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Comparison to Predicate Devices: 7.

Specification Comparison

	New Device	Predicate Device
Item	GE Blood GlucoseMonitoring System 333	Rightest GM550
Similarities
Measuring Range	20-600 mg/dL
Sample	Capillary whole blood (finger, palm and forearm)
Measurement Technology	Oxidase Electrochemical Sensor
Strip Reagent	1.Glucose Oxidase (GOD) 14.8%2.Potassium ferricyanide 39.5%3.Non-reactive ingredients 45.7%
The unit of measurement data	Fix on mg/dL
Shelf Life after opened vial	3 months
Test Time	5 seconds
Coding	Auto coding
Operating Temperature Range	50~104 °F (10 ~ 40°C)
Operating Relative HumidityRange	10 ~ 90%
Test Strip Storage Conditions	39~86 °F (4 ~ 30°C), < 90% relative humidity
Meter Storage Conditions	14~140 °F (-10 ~ 60°C)
Monitor	LCD display
Memory Capacity	500 blood glucose test results with date and time
Control solution	2 levels (Level 2 and 4, GC550)
Differences
Interference	Ascorbic acid ≥ 5 mg/dLCholesterol ≥ 600 mg/dL	Uric acid ≥ 10mg/dLL-Dopa ≥ 3mg/dL
		Dopamine $\ge$ 2mg/dL
		Ascorbic acid $\ge$ 5 mg/dL
Intended Use	In vitro diagnostic use - OTC	In vitro diagnostic use - OTCand POC
Hematocrit Range	20-60%	30-60%
Minimum Sample Volume	0.75 µL	1 µL
Backlight	No	Yes
Power Supply	Two 1.5V (AAA) batteries	Two CR2032 batteries
Meter Dimension	85 mm × 57 mm × 22.5 mm	90.6 mm × 46 mm × 16.5 mm
Meter Weight	81.0 ± 5 g with batteries	53.0 ± 5 g with batteries
Battery Life	About 800 tests	About 1000 tests
LCD display area	39 mm × 39.5 mm	47 mm × 33.5 mm
Wireless module	Bluetooth 4.0 (Low energy)	No

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8. Technology Characteristics:

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

Rightest Blood Glucose Meter GM232 and Rightest Blood Glucose Test Strips GS550 were used for testing, which are identical to GE Blood Glucose Meter 333 and GE Blood Glucose Test Strips 333, respectively, with the exception of trade name.

Verification and validation of test results were evaluated to establish the performance, functionality and reliability of the GE Blood Glucose Monitoring System 333. The evaluation included precision, linearity, interference, sample volume and hematocrit.

The following studies and evaluations were either performed internally by professional personnel in Bionime or by third party, performed by qualified personnel, with proper calibrated/maintained equipment and under properly-controlled environmental conditions. All of the evaluated performances passed and meet the acceptance criteria set forth in the study protocol.

Linearity

The linearity study evaluated detection range using 3 lots of blood glucose test strips. Venous blood samples spiked to 15 levels of glucose concentrations were used, ranging from low to high level (0 to 604 mg/dL), and evaluated compared to reference method YSI 2300 analyzer.

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Bionime Corporation

The tested glucose concentration ranged from 0 to 604 mg/dL. Analysis of results indicated linear regression between device and reference method shows mean slopes above 0.9912 and R2 values above 0.999. The results support the claim that glucose assay is linear from 20-600 mg/dL - identical to prior 510k cleared claims. The linearity study report is attached for your review.

Precision:

Based on the requirements, the precision study evaluated repeatability - conducted over 10 days at 5 glucose concentrations, and intermediate precision - conducted over 10 days at 3 glucose concentrations. 10 meters (3 models), 3 lots of test strips were used; 1500 test strips were used for repeatability evaluation and 900 test strips were used for intermediate precision evaluation. The venous blood sample results were compared against reference method YSI 2300 Analyzer.

The repeatability evaluation and intermediate precision evaluation results demonstrate that repeatability and intermediate precision falls within the acceptance criteria. The precision study report is attached for your review.

Sample Volume

The sample volume study evaluated sample volume using 3 lots of blood glucose test strips. Venous blood at 3 glucose concentration levels and at 9 sample volumes (ranging from 0.60 to 3.0 µL) was used.

The sample volume study results demonstrate that when sample volumes were less than 0.60uL. meter displayed error message (Er4). At all other sample volumes (greater than 0.65 µL), the results were within the accepted criteria of ±10% bias compared to reference. Thus, the minimum sample volume is 0.75 µL.

Interference Study

Based on the requirements and standards of CLSI: EP7-A2, the interference study evaluated interference substances using 3 lots of test strips at 2 glucose concentration levels of venous blood samples, and 19 interference substances.

According to study results, ascorbic acid (≥ 5 mg/dL), cholesterol (600 mg/dL), and uric acid (≥ 10 mg/dL) indicate percentage of interference over ±10% bias in high glucose concentration. This may lead to inaccurate test results, and is stated in the limitations section of the test strip package insert. The remaining 16 interference substances are within the criteria for normal and high glucose concentrations.

Hematocrit Study

The Hematocrit Study evaluated hematocrit levels using 3 lots of blood glucose test strips (HCT range 20-60%) at 6 glucose concentration levels of venous blood samples, tested in 5 replicates. The results were compared against reference method YSI 2300 Analyzer.

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The obtained study results indicate that the stability compared to the reference method during various HCT ranges were all within the criteria of ±15% of reference value. The acceptable HCT range is 20-60%.

10. Discussion of Clinical Test Performed:

System Accuracy Study:

System accuracy and precision was evaluated to 1) determine if subject device meets criteria and EGA, and 2) asses clinical performance of measuring glucose in capillary whole blood obtained from fingertip, palm, and/or forearm. The study was performed by comparing blood glucose values measured on subject device with values measured on comparative meter (Roche ACCU-CHEK Performa), with YSI 2300 Plus Glucose Analyzer used as a reference.

A total of 103 patients were participated. The study result demonstrates that the accuracy of subject device met the acceptance criteria, and there was no significant difference in slope, intercept, and correlation coefficient between the comparative meter or reference lab instrument.

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 160 laypersons in multiple sites. The study result shows substantial equivalence to predicate device used in finger, palm and forearm position.

11. Conclusions:

Results of non-clinical and clinical performance evaluation of the GE Blood Glucose Monitoring System 333 demonstrate that the device is substantially equivalent to the predicate device, Rightest Blood Glucose Monitoring System GM550.

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.