(153 days)
Not Found
No
The description focuses on data transfer, viewing, analysis (charts, tables), and reporting of blood glucose readings. There is no mention of predictive modeling, pattern recognition beyond simple analysis, or any other function typically associated with AI/ML. The system explicitly states it is not intended to provide treatment decisions.
No.
The devices referenced are monitoring systems and software aid for managing diabetes, but not for providing treatment decisions or substituting professional opinion, which means they are not therapeutic devices.
Yes
The document explicitly states that the various "Rightest Blood Glucose Monitoring System" devices (e.g., GM700, GM650, GM300) and "GE Blood Glucose Monitoring System" devices (e.g., GE200, GE300) are "intended for in vitro diagnostic use" and capable of "quantitative measurement of glucose". For example, "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." This indicates their use in diagnosing or monitoring a health condition.
No
The device description explicitly states that the system includes hardware components such as PC link adapters (GP550, GP700, GP650, GP300, GE GP550, GE GP700, GE GP300) and installation CDs. While the software is a key part of the system, it is not the sole component.
Based on the provided text, the Bionime Rightest Diabetes Management System and the GE Diabetes Management System software themselves are not IVDs.
Here's why:
- Their intended use is for viewing, analyzing, printing, backing up, and recovering blood glucose readings. They are described as "an aid for managing diabetes" and explicitly state they are "not intended to provide treatment decisions, nor should it substitute professional opinion."
- They do not perform the actual measurement of glucose. They receive data from glucose meters.
- The text clearly identifies the glucose meters and test strips as IVDs. For example, the Rightest Blood Glucose Monitoring System GM700 is described as "intended for self testing outside the body (in vitro diagnostic use)".
Therefore, while the software systems are part of a larger diabetes management system that includes IVD components (the glucose meters and test strips), the software itself does not meet the definition of an In Vitro Diagnostic device as described in the provided text.
N/A
Intended Use / Indications for Use
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.
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.
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.
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 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.
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 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).
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, forcarm or paim.
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 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),
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.
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,
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.
Product codes (comma separated list FDA assigned to the subject device)
NBW, LFR, CGA, JQP
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.
- 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.
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.
- 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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingertips, forearm, palm
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Health Care Professionals and Patients with diabetes at home.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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.
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.
Electromagnetic Compatibility (EMC): Testing and compliance reports were performed by SGS Taiwan Electronics & Communication Laboratory to evaluate the compliance of safety requirements for electrical equipment – PC Adapters (GP300, GP650, and GP700). 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K110737 and K123008, K120423 and K123008, K062567, K123008, K120423 and K123008, K113007, K113007/A001
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 Test | ||||
| System | NBW: Blood Glucose | |||
| Test System, Over-the- | ||||
| Counter | Class II | 21 CFR § | ||
| 862.1345 | Clinical | |||
| Chemistry | ||||
| (75) | ||||
| Glucose Test | ||||
| System | LFR: Glucose | |||
| Dehydrogenase, | ||||
| Glucose | Class II | 21 CFR § | ||
| 862.1345 | Clinical | |||
| Chemistry | ||||
| (75) | ||||
| Glucose Test | ||||
| System | CGA: Glucose | |||
| Oxidase, Glucose | Class II | 21 CFR § | ||
| 862.1345 | Clinical | |||
| Chemistry | ||||
| (75) | ||||
| Calculator/Data | ||||
| Processing Module | JQP: Calculator/ Data | |||
| Processing Module for | Class I | 21 CFR § | ||
| 862.2100 | Clinical | |||
| Chemistry |
1
| 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.
2
- 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.
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.
- 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.
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.
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
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
8 - 3
3
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.
b. GE Diabetes Management System
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.
Rightest Blood Glucose Monitoring System GM700: ﻦ
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.
4
d. Rightest Blood Glucose Monitoring System GM650:
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.
e. Rightest Blood Glucose Monitoring System GM300:
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.
f. GE200 Blood Glucose Monitoring System:
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).
5
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.
g. GE300 Talking Blood Glucose Monitoring System:
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.
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 |
6
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 Rightest | |||
| Diabetes Management | ||||
| System | GE Diabetes | |||
| Management System | Bionime Diabetes | |||
| Management System | ||||
| (BDMS) | GE Diabetes | |||
| Management System | ||||
| Similarities | ||||
| Intended use/ | ||||
| Indication(s) for use | Same | Same | BDMS is intended for use by Health Care | |
| professionals and patients with diabetes. When it is | ||||
| installed on a personal computer (PC), a database | ||||
| can be used to store multiple users' profiles and | ||||
| manage their blood glucose readings. People who | ||||
| use BDMS must login to their own profile. BDMS | ||||
| enables users to view and organize the blood | ||||
| glucose readings which are uploaded from Rightest | ||||
| Glucose meter(s). Users can backup and recover | ||||
| their profiles and print blood glucose data and | ||||
| report from their PC. | ||||
| COM Ports scan | Same | Automatic scan for connected ports | ||
| Multiple patients | Same | Can list data for multiple patients | ||
| Data list/ Summary | ||||
| report | 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 multiple | ||
| databases | ||||
| Reports and charts | Same | Data List, Standard Day report, Trend report, Pie | ||
| charts |
Specification Comparison
8 - 7
7
Bionime Corporation
| Change Meter settings | Same | Does not allow change to meter settings through the Diabetes Management System |
|---|---|---|
| Operating System | Same | Windows XP ProfessionalTM |
| Windows Vista ProfessionalTM | ||
| Windows 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/K12300 |
- | GP550 |
| Similarities/Differences | | | | |
| Operation | The meter connected to the adapter by plug in
and transmit data to computer. | | Same | |
| Connection | Mini USB port | Plug in to meter
USB Port | Same | Same |
| Function | A device of quantitative
glucose measuring system. | A device to transmit
data from meter. | Same | Same |
| Feature | Up to 1000 data stored | Cable | Same | Same |
| Appearance | A meter with a display
window, two side buttons,
one main button, and a test
strip port. | A connector to
meter and computer | Same | Same |
| Minimum Sample
Volume | 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
Relative Humidity
Range | 10-90% | None Applicable | Same | None Applicable |
| Memory Capacity | 1000 blood glucose test
results with date and time | None Applicable | Same | None Applicable |
| Coding | Auto Coding | None Applicable | Same | None Applicable |
| Meter Storage
Conditions | 14140 (-1060) | None Applicable | Same | None Applicable |
| Test Strip Storage
Conditions | 3986 (430), 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.
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.
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.
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.
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).
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, forcarm or paim.
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 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 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),
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.
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,
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.
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)