The Bionime Rightest Diabetes Management System is an over-the-counter software system for use by Health Care Professionals and Patients with diabetes as an aid for managing diabetes. User(s) can transfer blood glucose readings from the following glucose meters: Rightest Blood Glucose Monitoring System GM550 and GM250 with Rightest PC Link Adaptor (GP550), Rightest Blood Glucose Monitoring System GM700 with Rightest PC Link Adaptor (GP550) or Rightest Bluetooth PC Link (GP700), Rightest Blood Glucose Monitoring System GM650 with Rightest PC Link Adaptor for GM650 (GP650), and Rightest Blood Glucose Monitoring System GM300 with Rightest PC Link Adaptor for GM300 (GP300) to a personal computer for the purpose of viewing, analyzing and printing the blood glucose readings, as well as to backup and to recover users' profile and data.

The Bionime Rightest Diabetes Management System is not intended to provide treatment decisions, nor should it substitute professional opinion. All medical diagnoses and treatment plans should be performed by a licensed healthcare professional.

The GE Diabetes Management System is an over-the-counter software system for use by Health Care Professionals and Patients with diabetes as an aid for managing diabetes. User(s) can transfer blood glucose readings from the following glucose meters: GE100 Blood Glucose Monitoring System with GE PC Link Adaptor (GE GP550), GE300 Talking Blood Glucose Monitoring System with GE PC Link Adaptor for GE300 (GE GP300) or GE200 Blood Glucose Monitoring System with GE PC Link Adaptor (GE GP5500 and GE Bluetooth PC Link (GE GP700) to a personal computer for the purpose of viewing, analyzing and printing the blood glucose readings, as well as to backup and to recover users' profile and data.

The GE Diabetes Management System is not intended to provide treatment decisions. nor should it substitute professional opinion. All medical diagnoses and treatment plans should be performed by a licensed health care professional.

The Rightest Blood Glucose Monitoring System GM700 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 Rightest Blood Glucose Monitoring System GM700 is intended to be used by a single person and should not be shared.

The Rightest Blood Glucose Monitoring System GM700 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 Rightest Blood Glucose Monitoring System GM700 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 Rightest Blood Glucose Test Strips GS700 are for use with the Rightest Blood Glucose Meter GM700 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

The Rightest Blood Glucose Monitoring System GM650 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 Rightest Blood Glucose Monitoring System GM650 is intended to be used by a single person and should not be shared.

The Rightest Blood Glucose Monitoring System GM650 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 Rightest Blood Glucose Monitoring System GM650 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 Rightest Blood Glucose Test Strips GS650 are for use with the Rightest Blood Glucose Meter GM650 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

The Rightest Blood Glucose Monitoring System GM300 is intended for in vitro diagnostic use (outside of body). It is indicated to be used by professional healthcare personnel or diabetes 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 GM300. This device is not intended for testing neonate blood samples.

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

The GE200 Blood Glucose Monitoring System 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 GE200 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The GE200 Blood Glucose Monitoring System 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 GE200 Blood Glucose Monitoring System 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 GE200 Blood Glucose Test Strips are for use with the GE200 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

The GE300 Talking Blood Glucose Monitoring System 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 GE300 Talking Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The GE300 Talking Blood Glucose Monitoring System 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 GE300 Talking Blood Glucose Monitoring System 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 GE300 Blood Glucose Test Strip is for use with the GE300 Talking Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

Device Description

Rightest Blood Glucose Monitoring System GM700 consists of following devices: Rightest Blood Glucose Meter GM700, Rightest Blood Glucose Test Strip GS700, Rightest Control Solution GC700, lancing device and sterile lancets. The Rightest Blood Glucose Meter GM700, when used with the Rightest Blood Glucose Test Strips GS700, quantitatively measures glucose in fresh capillary whole blood. The performance of the Rightest Blood Glucose Monitoring System GM700 is verified by the Rightest Control Solution GC700.

Rightest Blood Glucose Monitoring System GM650 consists of following devices: Rightest Blood Glucose Meter GM650, Rightest Blood Glucose Test Strip GS650. Rightest Control Solution GC650, lancing device and sterile lancets. The Rightest Blood Glucose Meter GM650, when used with the Rightest Blood Glucose Test Strips GS650, quantitatively measures glucose in fresh capillary whole blood. The performance of the Rightest Blood Glucose Monitoring System GM650 is verified by the Rightest Control Solution GC650.

Rightest Blood Glucose Monitoring System GM300 consists of following devices: Rightest Blood Glucose Meter GM300, Rightest Blood Glucose Test Strip GS300, Rightest Control Solution GC300, lancing device and sterile lancets. The Rightest Blood Glucose Meter GM300, when used with the Rightest Blood Glucose Test Strips GS300, quantitatively measures glucose in fresh capillary whole blood. The performance of the Rightest Blood Glucose Monitoring System GM300 is verified by the Rightest Control Solution GC300.

GE200 Blood Glucose Monitoring System consists of following devices: GE200 Blood Glucose Meter, GE200 Blood Glucose Test Strip, GE200 Control Solution, lancing device and steriled lancets. The GE200 Blood Glucose Meter, when used with the GE200 Blood Glucose Test Strips, quantitatively measures glucose in fresh capillary whole blood. The performance of the GE200 Blood Glucose Monitoring System is verified by the GE200 Control Solution

GE300 Talking Blood Glucose Monitoring System consists of following devices: GE300 Talking Blood Glucose Meter, GE300 Talking Blood Glucose Test Strip, GE300 Series Control Solution, lancing device and sterile lancets. The GE300 Talking Blood Glucose Meter, when used with the GE300 Talking Blood Glucose Test Strips, quantitatively measures glucose in fresh capillary whole blood. The performance of the GE300 Talking Blood Glucose Monitoring System is verified by the GE300 Series Control Solution.

The Bionime Rightest Diabetes Management System allows the transfer of blood glucose readings from a compatible Rightest Glucose meter to a PC via PC link adapter (through USB and wireless connection). The Data analysis features enable the user(s) to view and analyze blood glucose readings from different meal time periods. Other features including data tables, trend charts, pie charts, and printed reports are available for viewing and analyzing these readings within the different time slots.

The revised system includes: 1) Installation CD with setup files for Rightest GP200 Diabetes Management Software and Rightest PC Link Adapter Driver, 2) One or multiple Rightest Adapters: GP550, GP700, GP650 and GP300 Compatible Meters include: GM250, GM550, GM700, GM650 and GM300.

The GE Diabetes Management System allows the transfer of blood glucose readings from a compatible GE Glucose meter to a PC via PC link adapter (through USB and wireless connection). The Data analysis features enable the user(s) to view and analyze blood glucose readings from different meal time periods. Other features including data tables, trend charts, pie charts, and printed reports are available for viewing and analyzing these readings within the different time slots.

The revised system includes: 1) Installation CD with setup files for GE GP200 Diabetes Management Software and GE PC Link Adapter Driver, 2) One or multiple GE Adapters: GE GP550, GE GP700 and GE GP300. Compatible Meters include: GE100, GE200 and GE300.

AI/ML Overview

The provided text describes the submission of a 510(k) premarket notification for several blood glucose monitoring systems and associated diabetes management software (BIONIME CORPORATION, K133522). The submission aims to add additional compatible meters and adapters to existing cleared systems. The studies primarily focus on the functional verification of data transfer and system usability for the diabetes management software, rather than the analytical performance of the blood glucose meters themselves (which are largely established through predicate devices).

Here's an analysis of the acceptance criteria and the studies that prove the device meets them, based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied functional requirements and satisfactory user performance.

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Data Transmission Accuracy	Full set of data (up to the meter's memory capacity) transferred from meter to software must be accurately downloaded.	Passed: Full set of data (1000 records for GM700, 500 for GM650/GE300, 300 for GM300, 1000 for GE200) transferred from meter to software was accurately downloaded for all tested meter/adapter combinations (Rightest GM700/GP550, Rightest GM700/GP700, Rightest GM650/GP650, Rightest GM300/GP300, GE200/GEGP550, GE200/GEGP700, GE300/GEGP300).
Memory Data Rollover	Meter memory data rollover must be accurately transmitted to the Diabetes Management System with additional new data.	Passed: Meter memory data rollover accurately transmitted to Rightest/GE DMS with additional new data for all tested meter/adapter combinations that have rollover (implied for all, explicitly stated for GM700, GM300, GE200, GE300).
User Performance	English-speaking laypersons must be able to follow user instructions for PC link adapters and software user manual to successfully connect the adapters/meters to a PC and import data to the GP200 Diabetes Management Software.	Passed: The study demonstrates that English-speaking laypersons are able to follow user instructions to successfully connect PC Link Adapters and paired meters to a PC and import data to the GP200 Diabetes Management Software.
Electromagnetic Compatibility (EMC)	PC Link Adapters (GP300, GP650, GP700) must meet performance criteria indicated by relevant safety standards for electrical equipment.	Passed: EMC reports confirmed that each PC Adapter met performance criteria indicated by the standards.
Readability Assessment	PC Adapter Guides and PC Adapter User Manuals for both Rightest BDMS and GE DMS Software must achieve a Flesch-Kincaid Grade Level indicating comprehension by an average eighth-grade student (implied acceptance score based on reported results).	Passed: Assessments ranged from 6.2 to 7.4 Flesch-Kincaid Grade Level, indicating each text is expected to be understood by an average student in the eighth grade, thus meeting the criteria.

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

Data Transmission Memory Rollover Synchronization Verification: The test set used "3 meters per adapter." The data provenance is not explicitly stated (e.g., country of origin) but would be prospective controlled testing performed by the manufacturer.
User Performance Evaluation: 45 participants were used for the test set. The study was conducted from October to December 2013. Data provenance is implied to be prospective testing conducted under controlled conditions, likely in Taiwan (country of the submitter, BIONIME CORPORATION).
Electromagnetic Compatibility (EMC): The sample size isn't specified but typically involves a single unit or a small number of units of each adapter type (GP300, GP650, GP700) for testing. This would be prospective testing.
Readability Assessment: The "sample size" here refers to the documents themselves (PC Adapter Guides and PC Adapter User Manuals). This is analysis of existing documentation.

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

For the Data Transmission and EMC tests, "ground truth" is established by direct observation and comparison against expected functional behavior and established engineering standards. No human experts are explicitly mentioned for establishing ground truth in the sense of clinical interpretation.
For the User Performance Evaluation, the "ground truth" of successful operation is determined by the layperson participants' ability to complete the tasks as instructed. There were no "experts" establishing a ground truth for individual performance, but rather the study design aimed to assess the usability by the target user group (laypersons).
For the Readability Assessment, the Flesch-Kincaid Grade Level score is an algorithmic measure of readability, so no human experts were involved in establishing the "ground truth" of readability other than the developers of the readability index itself.

4. Adjudication Method for the Test Set

For Data Transmission and EMC, the "adjudication" is based on direct verification against defined functional requirements and technical standards. There isn't an adjudication method like 2+1 or 3+1 typically used in image interpretation studies. It's a pass/fail determination based on objective criteria.
For User Performance Evaluation, the method of judging success by the 45 participants is not detailed, but it's presumed to be direct observation of task completion. No mention of an adjudication panel.
For Readability Assessment, the Flesch-Kincaid algorithm provides the score, not human 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

There was no MRMC comparative effectiveness study done. The devices covered in this submission are blood glucose monitoring systems and their associated data management software. These are not AI-based diagnostic image interpretation systems or similar devices where MRMC studies with human readers and AI assistance would typically be conducted. The tests performed are for functional performance and user interface/usability of data logging and transfer.

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

While the blood glucose meters themselves operate "standalone" in their measurement function, the studies reported here are primarily focused on the data management software. The data transmission and rollover verification tests are essentially "standalone" evaluations of the software's ability to accurately receive and store data from the meters without human intervention influencing the data transfer accuracy. The user performance study, however, explicitly involves a human-in-the-loop to evaluate usability.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Data Transmission Accuracy and Memory Rollover: The ground truth is the "expected" or "correct" transfer and storage of data, which is objectively verifiable. This is a functional ground truth, not a clinical one.
User Performance Evaluation: The ground truth is the successful completion of tasks by laypersons following instructions. This is a usability/human factors ground truth.
EMC: The ground truth is compliance with international safety and electromagnetic compatibility standards. This is a regulatory/engineering ground truth.
Readability Assessment: The ground truth is the calculated Flesch-Kincaid Grade Level score, an objective linguistic measure.

8. The Sample Size for the Training Set

This submission does not discuss AI algorithms that require training sets in the conventional sense. The "systems" being evaluated are hardware (meters, adapters) and software for data management, not machine learning models. Therefore, there is no mention of a training set of data for any AI algorithm.

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

Since there is no training set mentioned in the context of AI/machine learning, this question is not applicable to the provided document. The functional evaluations performed, such as data transmission, are verified against the design specifications and expected behavior, not against a "ground truth" derived from a separate training process.

Summary

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510(K) SUMMARY

APR 1 7 2014

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: K133522

1. Submitter's Identification:

BIONIME CORPORATION No. 100, Sec. 2, Daging St., South Dist., Taichung City 40242, Taiwan (R.O.C.)

c/o IVDD Regulatory Consultant 2700 La Paz Road, Suite 266B Mission Viejo, CA 92691 Contact Person: Feng-Yu Lee Phone Number: 1-949-951-3046 FAX Number: 1-949-951-2042

Date Summary Prepared: April 15, 2014

2. Name of the Device:

Rightest Blood Glucose Monitoring System GM700 Rightest Blood Glucose Monitoring System GM650 Rightest Blood Glucose Monitoring System GM300 GE300 Talking Blood Glucose Monitoring System GE200 Blood Glucose Monitoring System Bionime Rightest Diabetes Management System GE Diabetes Management System

3. Common or Usual Name:

Device Name	Product Code	Classification	Regulation	Panel
Glucose TestSystem	NBW: Blood GlucoseTest System, Over-the-Counter	Class II	21 CFR §862.1345	ClinicalChemistry(75)
Glucose TestSystem	LFR: GlucoseDehydrogenase,Glucose	Class II	21 CFR §862.1345	ClinicalChemistry(75)
Glucose TestSystem	CGA: GlucoseOxidase, Glucose	Class II	21 CFR §862.1345	ClinicalChemistry(75)
Calculator/DataProcessing Module	JQP: Calculator/ DataProcessing Module for	Class I	21 CFR §862.2100	ClinicalChemistry

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for Clinical Use	Clinical Use		(75)

4. Device Description:

4.1 Rightest Blood Glucose Monitoring System GM700 consists of following devices: Rightest Blood Glucose Meter GM700, Rightest Blood Glucose Test Strip GS700, Rightest Control Solution GC700, lancing device and sterile lancets. The Rightest Blood Glucose Meter GM700, when used with the Rightest Blood Glucose Test Strips GS700, quantitatively measures glucose in fresh capillary whole blood. The performance of the Rightest Blood Glucose Monitoring System GM700 is verified by the Rightest Control Solution GC700.
4.2 Rightest Blood Glucose Monitoring System GM650 consists of following devices: Rightest Blood Glucose Meter GM650, Rightest Blood Glucose Test Strip GS650. Rightest Control Solution GC650, lancing device and sterile lancets. The Rightest Blood Glucose Meter GM650, when used with the Rightest Blood Glucose Test Strips GS650, quantitatively measures glucose in fresh capillary whole blood. The performance of the Rightest Blood Glucose Monitoring System GM650 is verified by the Rightest Control Solution GC650.
4.3 Rightest Blood Glucose Monitoring System GM300 consists of following devices: Rightest Blood Glucose Meter GM300, Rightest Blood Glucose Test Strip GS300, Rightest Control Solution GC300, lancing device and sterile lancets. The Rightest Blood Glucose Meter GM300, when used with the Rightest Blood Glucose Test Strips GS300, quantitatively measures glucose in fresh capillary whole blood. The performance of the Rightest Blood Glucose Monitoring System GM300 is verified by the Rightest Control Solution GC300.
4.4 GE200 Blood Glucose Monitoring System consists of following devices: GE200 Blood Glucose Meter, GE200 Blood Glucose Test Strip, GE200 Control Solution, lancing device and steriled lancets. The GE200 Blood Glucose Meter, when used with the GE200 Blood Glucose Test Strips, quantitatively measures glucose in fresh capillary whole blood. The performance of the GE200 Blood Glucose Monitoring System is verified by the GE200 Control Solution
4.5 GE300 Talking Blood Glucose Monitoring System consists of following devices: GE300 Talking Blood Glucose Meter, GE300 Talking Blood Glucose Test Strip, GE300 Series Control Solution, lancing device and sterile lancets. The GE300 Talking Blood Glucose Meter, when used with the GE300 Talking Blood Glucose Test Strips, quantitatively measures glucose in fresh capillary whole blood. The performance of the GE300 Talking Blood Glucose Monitoring System is verified by the GE300 Series Control Solution.

The following devices have already been cleared. The purpose of this submission is to add additional compatible meters for use with these systems.

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4.6 The Bionime Rightest Diabetes Management System allows the transfer of blood glucose readings from a compatible Rightest Glucose meter to a PC via PC link adapter (through USB and wireless connection).
The Data analysis features enable the user(s) to view and analyze blood glucose readings from different meal time periods. Other features including data tables, trend charts, pie charts, and printed reports are available for viewing and analyzing these readings within the different time slots.

Compatible Meters include: GM250, GM550, GM700, GM650 and GM300.

4.7 The GE Diabetes Management System allows the transfer of blood glucose readings from a compatible GE Glucose meter to a PC via PC link adapter (through USB and wireless connection).
The Data analysis features enable the user(s) to view and analyze blood glucose readings from different meal time periods. Other features including data tables, trend charts, pie charts, and printed reports are available for viewing and analyzing these readings within the different time slots.

Compatible Meters include: GE100, GE200 and GE300.

ડ. Intended Use/Indications for Use:

The Rightest and GE Diabetes Management System Software has been previously cleared by FDA under K113007 and K113007/A001, respectively.

a. Bionime Rightest Diabetes Management System

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for the purpose of viewing, analyzing and printing the blood glucose readings, as well as to backup and to recover users' profile and data.

b. GE Diabetes Management System

Rightest Blood Glucose Monitoring System GM700: ﻦ

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d. Rightest Blood Glucose Monitoring System GM650:

e. Rightest Blood Glucose Monitoring System GM300:

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

f. GE200 Blood Glucose Monitoring System:

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g. GE300 Talking Blood Glucose Monitoring System:

Predicate Device Information: 6.

The Rightest Blood Glucose Monitoring System and GE Blood Glucose Monitoring System are substantially equivalent to the predicate device noted below.

Name:	Rightest Blood Glucose Monitoring System GM700
Device Company:	Bionime Corporation
510(K) Number:	K110737 and K123008
Name:	Rightest Blood Glucose Monitoring System GM650
Device Company:	Bionime Corporation
510(K) Number:	K120423 and K123008
Name:	Rightest Blood Glucose Monitoring System GM300
Device Company: ·	Bionime Corporation
510(K) Number:	K062567
Name:	GE200 Blood Glucose Monitoring System
Device Company:	Bionime Corporation
510(K) Number:	K123008
Name:	GE300 Talking Blood Glucose Monitoring System
Device Company:	Bionime Corporation

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510(K) Number: K120423 and K123008

The Rightest Diabetes Management System and the GE Diabetes Management System are substantially equivalent to the predicate device noted below.

Name:	Bionime Diabetes Management System
Device Company:	Bionime Corporation
510(K) Number:	K113007
Name:	GE Diabetes Management System
Device Company:	Bionime Corporation
510(K) Number:	K113007/A001

7. Comparison to Predicate Devices:

	Subject Device		Predicate Device
Item	Bionime RightestDiabetes ManagementSystem	GE DiabetesManagement System	Bionime DiabetesManagement System(BDMS)	GE DiabetesManagement System
	Similarities
Intended use/Indication(s) for use	Same	Same	BDMS is intended for use by Health Careprofessionals and patients with diabetes. When it isinstalled on a personal computer (PC), a databasecan be used to store multiple users' profiles andmanage their blood glucose readings. People whouse BDMS must login to their own profile. BDMSenables users to view and organize the bloodglucose readings which are uploaded from RightestGlucose meter(s). Users can backup and recovertheir profiles and print blood glucose data andreport from their PC.
COM Ports scan	Same		Automatic scan for connected ports
Multiple patients	Same		Can list data for multiple patients
Data list/ Summaryreport	Same		List all readings inside selected time frame
Target periods	Same		Daily time periods can be changed
Average week	Same		7-day report
Average Day	Same		1-day report
Password	Same		Does not have password protection on the software
Providers	Same		Does not have providers but does allow for multipledatabases
Reports and charts	Same		Data List, Standard Day report, Trend report, Piecharts

Specification Comparison

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Bionime Corporation

Change Meter settings	Same	Does not allow change to meter settings through the Diabetes Management System
Operating System	Same	Windows XP ProfessionalTMWindows Vista ProfessionalTMWindows 7 ProfessionalTM
Associate a meter to a person	Same	Does not associate a meter to a person
Standard week report	Same	No standard week report

Additional Adapters and compatible meters to be added under this application (Rightest Diabetes Management System):

Table 1
Item	Subject Pairs (Meter / Adapter)		Predicate (Meter / Adapter)
	Meter	Adapter	Meter	Adapter
New pair 1	Rightest GM700	GP550	Rightest GM700(K110737/K123008)	GP550
Similarities/Differences
Operation	The meter connected to the adapter by plug inand transmit data to computer.		Same
Connection	Mini USB port	Plug in to meterUSB Port	Same	Same
Function	A device of quantitativeglucose measuring system.	A device to transmitdata from meter.	Same	Same
Feature	Up to 1000 data stored	Cable	Same	Same
Appearance	A meter with a displaywindow, two side buttons,one main button, and a teststrip port.	A connector tometer and computer	Same	Same
Minimum SampleVolume	0.75 µL	None Applicable	Same	None Applicable
Test Time	5 seconds	None Applicable	Same	None Applicable
Measuring Range	20-600 mg/dL	None Applicable	Same	None Applicable
OperatingRelative HumidityRange	10-90%	None Applicable	Same	None Applicable
Memory Capacity	1000 blood glucose testresults with date and time	None Applicable	Same	None Applicable
Coding	Auto Coding	None Applicable	Same	None Applicable
Meter StorageConditions	14~~140 (-10~~60)	None Applicable	Same	None Applicable
Test Strip StorageConditions	39~~86 (4~~30), <90% relative humidity	None Applicable	Same	None Applicable
The unit ofmeasurement data	Fix on mg/dL	None Applicable	Same	None Applicable

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Sample	Capillary whole blood	None Applicable	Same	None Applicable
Interference	Uric acid $ \geq $ 16 mg/dLXylose $ \geq $ 10 mg/dLAscorbic acid $ \geq $ 3 mg/dLDopamine HCl $ \geq $ 1.25mg/dLL-Dopa $ \geq $ 2 mg/dL	None Applicable	Same	None Applicable
Voice Function	No	None Applicable	Same	None Applicable
Strip Reagent	1.FAD-glucoseDehydrogenase (FAD-GDH) 12.1%2.Potassium ferricyanide48.5%3.Non-reactive ingredients39.4%	None Applicable	Same	None Applicable
MeasurementTechnology	DehydrogenaseElectrochemical Sensor	None Applicable	Same	None Applicable
OperatingTemperatureRange	43~~111 (6~~44)	None Applicable	Same	None Applicable
Compatible toDMS	Compatible to BionimeRightest DiabetesManagement System	Compatible toBionime RightestDiabetesManagementSystem	None Applicable	Same

Table 2

Item	Subject Pairs (Meter / Adapter)		Predicate (Meter / Adapter)
	Meter	Adapter	Meter	Adapter
New pair 2	Rightest GM700	GP700(Bluetooth)	Rightest GM700(K110737/K123008)	GP550
Similarities/Differences
Operation	The meter connected to the adapter by plug inand transmit data to computer.		Same
Connection	Mini USB port	Plug in to meterUSB Port	Same	Same
Function	A device of quantitativeglucose measuring system.	A device to transmitdata from meter.	Same	Same
Feature	Up to 1000 data stored	Wireless	Same	Cable
Appearance	A meter with a displaywindow, two side buttons,one main button, and a teststrip port.	A connector tometer.	Same	A connector to meter andcomputer
Minimum SampleVolume	0.75 $\mu L$	None Applicable	Same	None Applicable
Test Time	5 seconds	None Applicable	Same	None Applicable

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Measuring Range	20-600 mg/dL	None Applicable	Same	None Applicable
OperatingRelative HumidityRange	10-90%	None Applicable	Same	None Applicable
Memory Capacity	1000 blood glucose testresults with date and time	None Applicable	Same	None Applicable
Coding	Auto Coding	None Applicable	Same	None Applicable
Meter StorageConditions	14~~140 °F (-10~~60℃ )	None Applicable	Same	None Applicable
Test Strip StorageConditions	39~~86 °F (4~~30℃ ), <90% relative humidity	None Applicable	Same	None Applicable
The unit ofmeasurement data	Fix on mg/dL	None Applicable	Same	None Applicable
Sample	Capillary whole blood	None Applicable	Same	None Applicable
Interference	Uric acid ≥ 16 mg/dLXylose ≥ 10 mg/dLAscorbic acid ≥ 3 mg/dLDopamine HCl ≥ 1.25mg/dLL-Dopa ≥ 2 mg/dL	None Applicable	Same	None Applicable
Voice Function	No	None Applicable	Same	None Applicable
Strip Reagent	1.FAD-glucoseDehydrogenase (FAD-GDH) 12.1%2.Potassium ferricyanide48.5%3.Non-reactive ingredients39.4%	None Applicable	Same	None Applicable
MeasurementTechnology	DehydrogenaseElectrochemical Sensor	None Applicable	Same	None Applicable
OperatingTemperatureRange	43~~111 °F (6~~44°C )	None Applicable	Same	None Applicable
Compatible toDMS	Compatible to BionimeRightest DiabetesManagement System	Compatible toBionime RightestDiabetesManagementSystem	None Applicable	Same

Table 3

. . .

Item	Subject Pairs (Meter / Adapter)		Predicate (Meter / Adapter)
	Meter	Adapter	Meter	Adapter
New pair 3	Rightest GM650	GP650(USB)	Rightest GM650(K120423/K123008)	GP550
Similarities/Differences
Operation	The meter connected to the adapter by plug in		Same

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and transmit data to computer.
Feature	Up to 500 data stored	Cable	Same	Same
Function	A device of quantitativeglucose measuring system.	A device to transmitdata from meter.	Same	Same
Appearance	A meter with a displaywindow, two side buttons,one main button, and a test	A connector tometer and computer	Same	Same
Connection	strip port.Far-red sensor	Plug in	Same	Same
Minimum SampleVolume	0.75 µL	None Applicable	Same	None Applicable
Test Time	5 seconds	None Applicable	Same	None Applicable
Measuring Range	20-600 mg/dL	None Applicable	Same	None Applicable
Operating RelativeHumidity Range	10-90%	None Applicable	Same	None Applicable
Memory Capacity	500 blood glucose testresults with date and time	None Applicable	Same	None Applicable
Coding	Auto Coding	None Applicable	Same	None Applicable
Meter StorageConditions	$14~~140 °F (-10~~60℃ )$	None Applicable	Same	None Applicable
Test Strip StorageConditions	$39~~86 °F (4~~30℃ ), < 90%$ relative humidity	None Applicable	Same	None Applicable
The unit ofmeasurement data	Fix on mg/dL	None Applicable	Same	None Applicable
Sample	Capillary whole blood	None Applicable	Same	None Applicable
Interference	Uric acid $\geq$ 16 mg/dLXylose $\geq$ 10 mg/dLAscorbic acid $\geq$ 3 mg/dLDopamine HCl $\geq$ 1.25mg/dLL-Dopa $\geq$ 2 mg/dL	None Applicable	Same	None Applicable
Voice Function	Yes	None Applicable	Same	None Applicable
Strip Reagent	1.FAD-glucoseDehydrogenase (FAD-GDH) 12.1%2.Potassium ferricyanide48.5%3.Non-reactive ingredients39.4%	None Applicable	Same	None Applicable
MeasurementTechnology	DehydrogenaseElectrochemical Sensor	None Applicable	Same	None Applicable
OperatingTemperatureRange	$43~~111 °F (6~~44℃)$	None Applicable	Same	None Applicable
Compatible toDMS	Compatible to BionimeRightest DiabetesManagement System	Compatible toBionime RightestDiabetesManagement	None Applicable	Same

{11}------------------------------------------------

ableT	4
-----------	---

Item	Subject Pairs (Meter / Adapter)		Predicate (Meter / Adapter)
	Meter	Adapter	Meter	Adapter
New pair 4	Rightest GM300	GP300(USB)	Rightest GM300,(K062567)	GP550
Similarities/Differences
Operation	The meter connected to the adapter by plug inand transmit data to computer.		Same
Function	A device of quantitativeglucose measuringsystem.	A device to transmitdata from meter.	Same	Same
Appearance	A meter with a displaywindow, two sidebuttons, one main button,and a test strip port.	A connector to meterand computer	Same	Same
Connection	Code key base	Plug in	Same	Same
Feature	Up to 300 data stored	Cable	Same	Same
MinimumSample Volume	$1.4 \mu L$	None Applicable	Same	None Applicable
Test Time	8 seconds	None Applicable	Same	None Applicable
Measuring Range	20-600 mg/dL	None Applicable	Same	None Applicable
OperatingRelativeHumidity Range	10-90%	None Applicable	Same	None Applicable
MemoryCapacity	300 blood glucose testresults with date andtime	None Applicable	Same	None Applicable
Coding	Code Key	None Applicable	Same	None Applicable
Meter StorageConditions	14-140 °F (-10-60℃ )	None Applicable	Same	None Applicable
Test StripStorageConditions	39-86 °F (4-30℃ ), <90% relative humidity	None Applicable	Same	None Applicable
The unit ofmeasurementdata	Fix on mg/dL	None Applicable	Same	None Applicable
Sample	Capillary whole blood	None Applicable	Same	None Applicable
Interference	Uric acid $\geq$ 9 mg/dLMethyldopa $\geq$ 1.5mg/dLCholesterol $\geq$ 250mg/dLL-Dopa $\geq$ 1.5 mg/dL	None Applicable	Same	None Applicable
Voice Function	No	None Applicable	Same	None Applicable
Strip Reagent	1.Glucose Oxidase 8.5%2.Potassium ferricyanide	None Applicable	Same	None Applicable

{12}------------------------------------------------

	48.5%3.Non-reactiveingredients 43%
MeasurementTechnology	Glucose OxidaseElectrochemical Sensor	None Applicable	Same	None Applicable
OperatingTemperatureRange	50~~104 °F (10~~40℃ )	None Applicable	Same	None Applicable
Compatible toDMS	Compatible to BionimeRightest DiabetesManagement System	Compatible to BionimeRightest DiabetesManagement System	None Applicable	Same

Additional Adapters and compatible meters to be added under this application (GE Diabetes Management System):

Table 5
Item	Subject Pairs (Meter / Adapter)		Predicate (Meter / Adapter)
	Meter	Adapter	Meter	Adapter
New pair 1	GE200	GE GP550(USB)	GE200(K123008)	GE GP550
Similarities/Differences
Operation	The meter connected to the adapter by plug inand transmit data to computer.		Same
Connection	Mini USB port	Plug in	Same	Same
Function	A device of quantitativeglucose measuringsystem.	A device to transmitdata from meter.	Same	Same
Feature	Up to 1000 data stored	Cable	Same	Same
Appearance	A meter with a displaywindow, two side buttons,one main button, and atest strip port.	A connector to meterand computer	Same	Same
MinimumSample Volume	0.75 µL	None Applicable	Same	None Applicable
Test Time	5 seconds	None Applicable	Same	None Applicable
MeasuringRange	20-600 mg/dL	None Applicable	Same	None Applicable
OperatingRelativeHumidity Range	10-90%	None Applicable	Same	None Applicable
MemoryCapacity	1000 blood glucose testresults with date and time	None Applicable	Same	None Applicable
Coding	Auto Coding	None Applicable	Same	None Applicable
Meter StorageConditions	14~~140 °F (-10~~60°C )	None Applicable	Same	None Applicable
Test StripStorageConditions	39~~86 °F (4~~30°C ), < 90% relative humidity	None Applicable	Same	None Applicable
The unit ofmeasurement	Fix on mg/dL	None Applicable	Same	None Applicable

{13}------------------------------------------------

data
Sample	Capillary whole blood	None Applicable	Same	None Applicable
Interference	Uric acid $\geq$ 16 mg/dLXylose $\geq$ 10 mg/dLAscorbic acid $\geq$ 3 mg/dLDopamine HCl $\geq$ 1.25 mg/dLL-Dopa $\geq$ 2 mg/dL	None Applicable	Same	None Applicable
	Voice Function	No	None Applicable	Same	None Applicable
	Strip Reagent	1.FAD-glucoseDehydrogenase (FAD-GDH) 12.1%2.Potassium ferricyanide48.5%3.Non-reactiveingredients 39.4%	None Applicable	Same	None Applicable
	MeasurementTechnology	DehydrogenaseElectrochemical Sensor	None Applicable	Same	None Applicable
	OperatingTemperatureRange	43~~111 °F (6~~44℃ )	None Applicable	Same	None Applicable
Compatible toDMS	Compatible to GEDiabetes ManagementSystem	Compatible to GEDiabetes ManagementSystem	None Applicable	Same

Table 6

Item	Subject Pairs (Meter / Adapter)		Predicate (Meter / Adapter)
	Meter	Adapter	Meter	Adapter
New pair 2	GE200	GE GP700(Bluetooth)	GE200(K123008)	GE GP550
Similarities/Differences
Operation	The meter connected to the adapter by plug inand transmit data to computer.		Same
Connection	Mini USB port	Plug in	Same	Same
Function	A device of quantitativeglucose measuringsystem.	A device to transmitdata from meter.	Same	Same
Feature	Up to 1000 data stored	Wireless	Same	Cable
Appearance	A meter with a displaywindow, two side buttons,one main button, and atest strip port.	A connector to meter.	Same	A connector to meter andcomputer
MinimumSample Volume	0.75 µL	None Applicable	Same	None Applicable
Test Time	5 seconds	None Applicable	Same	None Applicable
MeasuringRange	20-600 mg/dL	None Applicable	Same	None Applicable

{14}------------------------------------------------

Bionime Corporation

OperatingRelativeHumidity Range	10-90%	None Applicable	Same	None Applicable
MemoryCapacity	1000 blood glucose testresults with date and time	None Applicable	Same	None Applicable
Coding	Auto Coding	None Applicable	Same	None Applicable
Meter StorageConditions	14~~140 °F (-10~~60℃ )	None Applicable	Same	None Applicable
Test StripStorageConditions	39~~86 °F (4~~30℃), <90% relative humidity	None Applicable	Same	None Applicable
The unit ofmeasurementdata	Fix on mg/dL	None Applicable	Same	None Applicable
Sample	Capillary whole blood	None Applicable	Same	None Applicable
Interference	Uric acid ≥ 16 mg/dLXylose ≥ 10 mg/dLAscorbic acid ≥ 3 mg/dLDopamine HCl ≥ 1.25mg/dLL-Dopa ≥ 2 mg/dL	None Applicable	Same	None Applicable
Voice Function	No	None Applicable	Same	None Applicable
Strip Reagent	1.FAD-glucoseDehydrogenase (FAD-GDH) 12.1%2. Potassium ferricyanide48.5%3.Non-reactiveingredients 39.4%	None Applicable	Same	None Applicable
MeasurementTechnology	DehydrogenaseElectrochemical Sensor	None Applicable	Same	None Applicable
OperatingTemperatureRange	43~~111 °F (6~~44℃ )	None Applicable	Same	None Applicable
Compatible toDMS	Compatible to GEDiabetes ManagementSystem	Compatible to GEDiabetes ManagementSystem	None Applicable	Same

{15}------------------------------------------------

Table 7:
Item	Subject Pairs (Meter / Adapter)		Predicate (Meter / Adapter)
	Meter	Adapter	Meter	Adapter
New pair 3	GE300	GE GP300(USB)	GE300(K120423/K123008)	GE GP550
Similarities/Differences
Operation	The meter connected to the adapter by plug in andtransmit data to computer.		Same
Feature	Up to 500 data stored	Cable	Same	Same
Function	A device of quantitativeglucose measuring system.	A device to transmitdata from meter.	Same	Same
Appearance	A meter with a displaywindow, two side buttons,one main button, and a teststrip port.	A connector to meterand computer	Same	Same
Connection	Far-red sensor	Plug in	Same	Same
MinimumSample Volume	0.75 µL	None Applicable	Same	None Applicable
Test Time	5 seconds	None Applicable	Same	None Applicable
MeasuringRange	20-600 mg/dL	None Applicable	Same	None Applicable
OperatingRelativeHumidity Range	10-90%	None Applicable	Same	None Applicable
MemoryCapacity	500 blood glucose testresults with date and time	None Applicable	Same	None Applicable
Coding	Auto Coding	None Applicable	Same	None Applicable
Meter StorageConditions	14~~140 °F (-10~~60℃ )	None Applicable	Same	None Applicable
Test StripStorageConditions	39~~86 °F (4~~30℃ ), <90% relative humidity	None Applicable	Same	None Applicable
The unit ofmeasurementdata	Fix on mg/dL	None Applicable	Same	None Applicable
Sample	Capillary whole blood	None Applicable	Same	None Applicable
Interference	Uric acid $\geq$ 16 mg/dLXylose $\geq$ 10 mg/dLAscorbic acid $\geq$ 3 mg/dLDopamine HCl $\geq$ 1.25mg/dLL-Dopa $\geq$ 2 mg/dL	None Applicable	Same	None Applicable
Voice Function	Yes	None Applicable	Same	None Applicable
Strip Reagent	1.FAD-glucoseDehydrogenase (FAD-GDH) 12.1%	None Applicable	Same	None Applicable
	2.Potassium ferricyanide48.5%3.Non-reactive ingredients39.4%
MeasurementTechnology	DehydrogenaseElectrochemical Sensor	None Applicable	Same	None Applicable
OperatingTemperatureRange	43~~111 °F (6~~44℃ )	None Applicable	Same	None Applicable
Compatible toDMS	Compatible to GEDiabetes ManagementSystem	Compatible to GEDiabetes ManagementSystem	None Applicable	Same

{16}------------------------------------------------

8. Discussion of Non-Clinical and Clinical Tests Performed for Determination of Substantial Equivalence:

Verification and validation of test results were evaluated to establish the performance, functionality and reliability of the Rightest Diabetes Management System, and the GE Diabetes Management System when used with the following systems: Rightest Blood Glucose Monitoring System GM700, Rightest Blood Glucose Monitoring System GM650, Rightest Blood Glucose Monitoring System GM300, GE300 Talking Blood Glucose Monitoring System, and GE200 Blood Glucose Monitoring System

Data Transmission Memory Rollover Synchronization Verification

Data transmission accuracy and memory data rollover synchronization were tested at each meter's full data memory capacity to ensure successful upload and storage into software database of the Rightest/GE Diabetes Management System. Software test used 3 meters per adapter.

Meter/Adapter	Expected Test Result	Result
Rightest GM700 Meter/GP550 Adapter (USB)	Full set of data (1000 records) transferredfrom meter to software was accuratelydownloadedMeter memory data rollover accuratelytransmitted to Rightest DMS withadditional new data	Pass
Rightest GM700 Meter/GP700 Adapter(Bluetooth)	Full set of data (1000 records) transferredfrom meter to software was accuratelydownloadedMeter memory data rollover accuratelytransmitted to Rightest DMS withadditional new data	Pass
Rightest GM650 Meter/GP650 Adapter (USB)	Full set of data (500 records) transferredfrom meter to software was accuratelydownloaded	Pass

{17}------------------------------------------------

Rightest GM300 Meter/GP300 Adapter (USB)	Meter memory data rollover accuratelytransmitted to Rightest DMS withadditional new dataFull set of data (300 records) transferredfrom meter to software was accuratelydownloaded	Pass
GE200 Meter/GEGP550 (USB)	Meter memory data rollover accuratelytransmitted to Rightest DMS withadditional new dataFull set of data (1000 records) transferredfrom meter to software was accuratelydownloaded	Pass
GE200 Meter/GEGP700 (Bluetooth)	Meter memory data rollover accuratelytransmitted to GE DMS with additionalnew dataFull set of data (1000 records) transferredfrom meter to software was accuratelydownloaded	Pass
GE300 Meter/GEGP300 (USB)	Meter memory data rollover accuratelytransmitted to GE DMS with additionalnew dataFull set of data (500 records) transferredfrom meter to software was accuratelydownloaded	Pass

User Performance Evaluation:

The User (Layperson) Performance Evaluation of PC Link Adapters study included 45 participants of varying age, sex, background, education level, and work experience. The study was conducted from October to December 2013.

The study demonstrates that English-speaking laypersons are able to follow user instructions for the PC link adapters and Software user manual to successfully connect PC Link Adapters and paired meter to PC installed and import data to GP200 Diabetes Management Software.

{18}------------------------------------------------

Electromagnetic Compatibility (EMC):

To evaluate the compliance of safety requirements for electrical equipment – PC Adapters (GP300, GP650, and GP700), the testing and compliance reports were performed by SGS Taiwan Electronics & Communication Laboratory.

The EMC reports confirmed that each PC Adapter met performance criteria indicated by the standards.

Readability Assessment:

The Readability Assessment Tests were performed using the Flesch-Kincaid Grade Level Score to evaluate the readability of the PC Adapter Guides and PC Adapter User Manuals for both Rightest BDMS and GE DMS Software.

The obtained results demonstrate that PC Adapter Guides and PC Adapter User Manuals for both Rightest BDMS and GE DMS Software each received a Flesch-Kincaid Grade Level that indicates each text is expected to be understood by an average student in the eighth grade. The assessments ranged from 6.2 to 7.4 and therefore each text meets the criteria.

9. Conclusion:

Results of performance evaluation of the Rightest Diabetes Management System and the GE Diabetes Management System with addition of compatible blood glucose meters and their respective PC Link Adapters demonstrate that the subject devices are substantially equivalent to the predicate devices.

{19}------------------------------------------------

Image /page/19/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that form the shape of the bird's body and wings.

Public Health Service

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

April 17, 2014

BIONIME COPORATION C/O FENG-YU LEE 2700 LA PAZ ROAD SUITE 266B MISSION VIEJO CA 92691

Re: K133522

Trade/Device Name: Rightest Blood Glucose Monitoring System GM700 Rightest Blood Glucose Monitoring System GM650 Rightest Blood Glucose Monitoring System GM300 GE300 Talking Blood Glucose Monitoring System GE200 Blood Glucose Monitoring System Bionime Rightest Diabetes Management System GE Diabetes Management System

Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, LFR, CGA, JOP Dated: March 03, 2014 Received: March 6, 2014

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

{20}------------------------------------------------

Page 2-Feng-Lu Lec

CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device 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.

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/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 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.

Sincerely yours.

Courtney H. Lias -S

Courtnev 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

{21}------------------------------------------------

Indications for Use

510(k) Number (if known) K133522

Device Name

GE Diabetes Management System

Indications for Use (Describe)

The GE Diabetes Management System is an over-the-counter software system for use by Health Care Professionals and Patients with diabetes as an aid for managing diabetes. User(s) can transfer blood glucose readings from the following glucose meters: GE100 Blood Glucose Monitoring System with GE PC Link Adaptor (GE GP550), GE300 Talking Blood Glucose Monitoring System with GE PC Link Adaptor for GE300 (GE GP300) and GE200 Blood Glucose Monitoring System with GE PC Link Adaptor (GE GP550) or GE Bluetooth PC Link (GE GP700) to a personal computer for the purpose of viewing, analyzing and printing the blood glucose readings, as well as to backup and to recover users' profile and data.

The GE Diabetes Management System is not intended to provide treatment decisions, nor should it substitute professional opinion. All medical diagnoses and treatment plans should be performed by a licensed health care professional.

Type of Use (Select one or both, as applicable)

[ Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement on last page.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY . .. . :: Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

{22}------------------------------------------------

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K133522

Device Name

Rightest Blood Glucose Monitoring System GM300

Indications for Use (Describe)

The Rightest Blood Glucose Monitoring System GM300 is intended for in vitro diagnostic use (outside of be used by professional healthcare personnel or diabetes at home to measure the glucose concentration for aiding diabetes management. The glucose concentration is measured with quantiative capillary whole blood from the fingertip, palm, and forearm by using Rightest Blood Glucose Monitoring System GM300. This device is not intended for testing neonate blood samples.

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

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

[x] Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

CHARGE CONTRACTOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

{23}------------------------------------------------

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K133522

Device Name

Rightest Blood Glucose Monitoring System GM700

Indications for Use (Describe)

The Rightest Blood Glucose Monitoring System GM700 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 Rightest Monitoring System GM700 is intended to be used by a single person and should not be shared.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FOR FOR FDA USE ONLY SEE oncurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Katherine Serrano -S

{24}------------------------------------------------

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page,

510(k) Number (if known) K133522

Device Name

Bionime Rightest Diabetes Management System

Indications for Use (Describe)

The Bionime Rightest Diabetes Management System is an over-the-counter system for use by Health Care Professionals and Patients with diabetes as an aid for managing diabetes. User(s) can transfer blood glucose readings from the following glucose meters; Rightest Blood Glucose Monitoring System GM250 with Rightest PC Link Adaptor (GP550), Rightest Blood Glucose Monitoring System GM700 with Rightest PC Link Adaptor (GP550) or Rightest Bluetooth PC Link (GP700), Rightest Blood Glucose Monitoring System GM650 with Rightest PC Link Adaptor for GM650 (GP650), and Rightest Blood Glucose Monitoring System GM300 with Rightest PC Link Adaptor for GM300 (GP300) to a personal computer for the purpose of viewing, and printing the blood glucose readings, as well as to backup and to recover users' profile and data.

Type of Use (Select one or both, as applicable)

[x] Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY oncurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Katherine Serrano -S

{25}------------------------------------------------

Indications for Use

510(k) Number (if known) K133522

Device Name

GE200 Blood Glucose Monitoring System

Indications for Use (Describe)

The GE200 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn the Ingertips. forearm or palm. The GE200 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared,

The GE200 Blood Glucose Monitaring System 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 GE200 Blood Glucose Monitoring System should not be used for the diagnosis of or sereening 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)

X Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

{26}------------------------------------------------

Indications for Use

510(k) Number (if known) K133522

Device Name

GE300 Talking Blood Glucose Monitoring System

Indications for Use (Describe)

The GE300 Talking Blood Glucose Monitoring System is intended for self testing outside the body (in virro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The GE300 Talking Blood Glucose Monitoring System 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)

X Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FOR FOR FDA USE ONLY CONLY CONTRACT OF . " Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

{27}------------------------------------------------

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K133522

Device Name

Rightest Blood Glucose Monitoring System GM650

Indications for Use (Describe)

The Rightest Blood Glucose Monitoring System GM650 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearn or palm. The Rightest Blood Glucose Monitoring System GM650 is intended to be used by a single person and should not be shared,

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

[X] Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FOR FOR FOR FOR FOR FOR FOR FOR : Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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.