(170 days)
Not Found
No
The summary describes a standard blood glucose monitoring system that measures glucose levels in blood samples. There is no mention of AI, ML, or any advanced analytical capabilities beyond quantitative measurement.
No
The device is a blood glucose monitoring system, intended for quantitative measurement of glucose and monitoring the effectiveness of diabetes control. It does not actively treat or directly mitigate a disease or condition, which is the primary function of a therapeutic device.
Yes
The device is described as an "in vitro diagnostic use" device, used to measure glucose levels as an aid to monitor the effectiveness of diabetes control. While it explicitly states it should not be used for diagnosis or screening of diabetes, its function of providing quantitative measurements of a biological marker for monitoring a medical condition classifies it as a diagnostic device.
No
The device description explicitly states that the system consists of a Blood Glucose Meter, Blood Glucose Test Strip, Control Solution, lancing device, and sterile lancets, which are all hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The intended use section for all listed systems (Rightest GM280B, GE 182, Rightest GM280, GE 180) explicitly states: "intended for self- testing outside the body (in vitro diagnostic use)".
- Nature of the Test: The device measures glucose in a biological sample (blood) outside the body to provide information about a person's health status (monitoring diabetes control). This is the core definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Rightest Blood Glucose Monitoring System GM280B is intended to 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 GM280B is intended to be used by a single person and should not be shared.
The Rightest Blood Glucose Monitoring System GM280B 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 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 Strip GS280 is used with Rightest meter GM280B for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
The GE Blood Glucose Monitoring System 182 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The GE Blood Glucose Monitoring System 182 is intended to be used by a single person and should not be shared.
The GE Blood Glucose Monitoring System 182 intended for self- testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The GE Blood Glucose Monitoring System 182 should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
The GE Blood Glucose Strip 180 is used with GE Blood Glucose Monitoring Meter 182 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 GM280 is intended to 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 GM280 is intended to be used by a single person and should not be shared.
The Rightest Blood Glucose Monitoring System GM280 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 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 Strip GS280 is used with Rightest meter GM280 for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
The GE Blood Glucose Monitoring System 180 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The GE Blood Glucose Monitoring System 180 is intended to be used by a single person and should not be shared.
The GE Blood Glucose Monitoring System 180 intended for self- testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The GE Blood Glucose Monitoring System 180 should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
The GE Blood Glucose Strip 180 is used with GE Blood Glucose Monitoring Meter 180 for the quantitative measurement of 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
Device Description
The Rightest and GE Blood Glucose Monitoring System series consists of the following devices: Blood Glucose Meter, Blood Glucose Test Strip, Control Solution, lancing device and sterile lancets. The Blood Glucose Meter, Blood Glucose Test Strips, and Lancing Device are manufactured by BIONIME Corporation.
The Rightest Blood Glucose Meter GM280 and Rightest Blood Glucose Meter GM280B, when used with the Rightest Blood Glucose Test Strips GS280, quantitatively measure glucose in fresh capillary whole blood. The performance of the Rightest Blood Glucose Monitoring System GM280 and Rightest Blood Glucose Monitoring System GM280B are verified by the Rightest Control Solution GC550.
The GE Blood Glucose Meter 180 and GE Blood Glucose Meter 182, when used with the GE Blood Glucose Test Strips 180, quantitatively measure glucose in fresh capillary whole blood. The performance of the GE Blood Glucose Monitoring System 180 and GE Blood Glucose Monitoring System 182 are verified by the Rightest Control Solution GC550.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertips, forearm or palm
Indicated Patient Age Range
Not Found
Intended User / Care Setting
single person, people 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
System Accuracy Study:
The system accuracy study of the Rightest Blood Glucose Monitoring System GM280 was performed by comparing capillary and venous whole blood (plasma equivalent) glucose values on the Rightest Blood Glucose Meter GM280 with glucose values on lab instrument YSI 2300 Plus Glucose Analyzer.
A total of 104 patients participated. The study results demonstrate that the accuracy of Rightest Blood Glucose Monitoring System GM280 met the acceptance criteria.
User Performance Study:
The user performance study was performed to demonstrate that English speaking and reading lay users across all educational backgrounds can easily understand and follow the labeling/user instructions to obtain accurate results while using Rightest Blood Glucose Monitoring System GM280B.
A total of 135 subjects participated. The study results demonstrate that the user accuracy and ease of use (via participant questionnaire scoring) Rightest Blood Glucose Monitoring System GM280B meet the acceptance 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.
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.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 6, 2017
Bionime Corporation % Feng-Yu Lee, Principal Consultant Dynamic Biotech Inc. dba IVDD Regulatory Consultant 29222 Rancho Vieio Road. Suite 218 San Juan Capistrano, California 92675
Re: K170143
Trade/Device Name: GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, Rightest Blood Glucose Monitoring System GM280, Rightest Blood Glucose Monitoring System GM280B Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: May 30, 2017 Received: June 7, 2017
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
1
with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 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 regulation (21 CFR Part 801 and Part 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Kellie B. Kelm -S
for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known) K170143
Device Name
Rightest Blood glucose monitoring System GM280B
Indications for Use (Describe)
The Rightest Blood Glucose Monitoring System GM280B is intended to 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 GM280B is intended to be used by a single person and should not be shared.
The Rightest Blood Glucose Monitoring System GM280B 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 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 Strip GS280 is used with Rightest meter GM280B for the quantitative measurement of 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
3
510(k) Number (if known) K170143
Device Name GE Blood glucose monitoring System 182
Indications for Use (Describe)
The GE Blood Glucose Monitoring System 182 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The GE Blood Glucose Monitoring System 182 is intended to be used by a single person and should not be shared.
The GE Blood Glucose Monitoring System 182 intended for self- testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The GE Blood Glucose Monitoring System 182 should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
The GE Blood Glucose Strip 180 is used with GE Blood Glucose Monitoring Meter 182 for the quantitative measurement of 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
4
510(k) Number (if known) K170143
Device Name
Rightest Blood glucose monitoring System GM280
Indications for Use (Describe)
The Rightest Blood Glucose Monitoring System GM280 is intended to 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 GM280 is intended to be used by a single person and should not be shared.
The Rightest Blood Glucose Monitoring System GM280 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 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 Strip GS280 is used with Rightest meter GM280 for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Repackaging Use (Part 21 CFR 201.66) Subject to Discretion | Over-The-Counter Use (21 CFR 201.66) Subject to Discretion |
|---|---|
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
5
510(k) Number (if known) K170143
Device Name GE Blood glucose monitoring System 180
Indications for Use (Describe)
The GE Blood Glucose Monitoring System 180 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The GE Blood Glucose Monitoring System 180 is intended to be used by a single person and should not be shared.
The GE Blood Glucose Monitoring System 180 intended for self- testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The GE Blood Glucose Monitoring System 180 should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
The GE Blood Glucose Strip 180 is used with GE Blood Glucose Monitoring Meter 180 for the quantitative measurement of 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) |
|---|---|
| ----------------------------------------------------------------------- | --------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
6
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.
The assigned 510(k) number is: K170143
-
- Submitter's Identification:
BIONIME CORPORATION NO 100, Sec. 2, Daqing St., South Dist., 40242 Taichung City, Taiwan Contact Person: Mr. Roy Huang Phone Number: 886-4-23692388 FAX Number: 886-4-22617568
- Submitter's Identification:
Date Summary Prepared: July 6, 2017
-
- Name of the Device: Rightest Blood Glucose Monitoring System GM280 Rightest Blood Glucose Monitoring System GM280B GE Blood Glucose Monitoring System 180 GE Blood Glucose Monitoring System 182
-
- Common or Usual Name: Glucose test system
| Product Code | Classification | Regulation Section | Panel |
|---|---|---|---|
| NBW; System, Test, Blood | |||
| Glucose, Over-the-Counter | Class II | 21 CFR 862.1345 | Clinical Chemistry 75 |
4. Device Description:
The Rightest and GE Blood Glucose Monitoring System series consists of the following devices: Blood Glucose Meter, Blood Glucose Test Strip, Control Solution, lancing device and sterile lancets. The Blood Glucose Meter, Blood Glucose Test Strips, and Lancing Device are manufactured by BIONIME Corporation.
The Rightest Blood Glucose Meter GM280 and Rightest Blood Glucose Meter GM280B, when used with the Rightest Blood Glucose Test Strips GS280, quantitatively measure glucose in fresh capillary whole blood. The performance of the Rightest Blood Glucose Monitoring System GM280 and Rightest Blood Glucose Monitoring System GM280B are verified by the Rightest Control Solution GC550.
The GE Blood Glucose Meter 180 and GE Blood Glucose Meter 182, when used with the GE Blood Glucose Test Strips 180, quantitatively measure glucose in fresh capillary whole
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blood. The performance of the GE Blood Glucose Monitoring System 180 and GE Blood Glucose Monitoring System 182 are verified by the Rightest Control Solution GC550.
న. Intended Use:
Rightest Blood Glucose Monitoring System GM280
The Rightest Blood Glucose Monitoring System GM280 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 GM280 is intended to be used by a single person and should not be shared.
The Rightest Blood Glucose Monitoring System GM280 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 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 Strip GS280 is used with Rightest meter GM280 for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
Rightest Blood Glucose Monitoring System GM280B
The Rightest Blood Glucose Monitoring System GM280B 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 GM280B is intended to be used by a single person and should not be shared.
The Rightest Blood Glucose Monitoring System GM280B 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 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 Strip GS280 is used with Rightest meter GM280B for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
GE Blood Glucose Monitoring System 180
The GE Blood Glucose Monitoring System 180 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
The GE Blood Glucose Monitoring System 180 is intended to be used by a single person and should not be shared.
The GE Blood Glucose Monitoring System 180 is intended for self- testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the
8
effectiveness of diabetes control. The GE Blood Glucose Monitoring System 180 should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
The GE Blood Glucose Strip 180 is used with GE Blood Glucose Monitoring Meter 180 for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
GE Blood Glucose Monitoring System 182
The GE Blood Glucose Monitoring System 182 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The GE Blood Glucose Monitoring System 182 is intended to be used by a single person and should not be shared.
The GE Blood Glucose Monitoring System 182 is intended for self- testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The GE Blood Glucose Monitoring System 182 should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
The GE Blood Glucose Strip 180 is used with GE Blood Glucose Monitoring Meter 182 for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
-
- Predicate Device Information:
The Rightest Blood Glucose Monitoring System GM280, Rightest Blood Glucose Monitoring System GM280B, GE Blood Glucose Monitoring System 180 and GE Blood Glucose Monitoring System 182 Blood Glucose Monitoring Systems are substantially equivalent to the following brand of Rightest Blood Glucose Monitoring System:
- Predicate Device Information:
| Name: | GE333 Blood Glucose Monitoring System |
|---|---|
| Device Company: | Bionime Corporation |
| 510(K) Number: | K143387 |
9
7. Comparison to Predicate Devices:
Specification Comparison
| Subject Devices | Predicate Device | ||
|---|---|---|---|
| Specification | Rightest GM280 | Rightest GM280B | GE333 |
| GE180 | GE182 | ||
| Indications for Use | Over-The-Counter: For single-patient use only, in-vitro diagnostic use only | ||
| by individuals with diabetes at home | |||
| Measurement | |||
| Technology | Glucose Oxidase Electrochemical Sensor | ||
| Sample Type | Capillary whole blood | ||
| Minimum Sample | |||
| Volume | 0.75 µL | ||
| Primary Site Testing | Fingertip | ||
| Alternative Site Testing | Forearm, Palm | ||
| Unit of Measurement | mg/dL | ||
| Measuring Range | 20-600 mg/dL | ||
| Measuring Time | 5 seconds | ||
| Hematocrit | 20-60 % | ||
| Control Solution | 3 levels (Level 1, 2, and 4) | ||
| Rightest Control Solution GC550 | |||
| Maximum Altitude | 10745 feet (3275 m) | ||
| Operating Conditions | Temperature 50 ~104 °F (10 ~ 40°C), | ||
| 10 ~ 90% Relative Humidity | |||
| Meter Storage | |||
| Conditions | 14~140 °F (-10 ~ 60°C) | ||
| Test Strip Storage | |||
| Conditions | 39 | ||
| 10-90% relative humidity | |||
| Test Strip Shelf Life | |||
| (After Opening) | 3 months | ||
| Interference | Ascorbic acid > 3 mg/dL | ||
| Glutathione reduced >60 mg/dL | |||
| Uric Acid > 12 mg/dL | Ascorbic acid ≥ 5 mg/dL | ||
| Cholesterol ≥ 600 mg/dL | |||
| Uric acid ≥ 10 mg/dL | |||
| Test Strip Reagent | Glucose Oxidase (GOD) 18.8 % | ||
| Potassium Ferricyanide 37.7 % | |||
| Non-reactive Ingredients 43.5 % | Glucose Oxidase (GOD) | ||
| 14.8% | |||
| Potassium ferricyanide | |||
| 39.5% | |||
| Non-reactive ingredients | |||
| 45.7% | |||
| Wireless module | No | Bluetooth 4.0 | |
| (Low energy) | |||
| Memory Capacity | 500 blood glucose test results with date and time | ||
| Power Saving | Turn off automatically 2 minutes after last user action / | ||
| Press the main button for 3 seconds. | |||
| Coding | Auto coding | ||
| Monitor | LCD display | ||
| Backlight | No | ||
| Power Supply | One CR2032 battery | Two AAA batteries | |
| Battery Life | 1000 tests | About 800 tests | |
| Meter Dimension | 82mm45mm15.5mm | 90.6mm46mm16.5mm | |
| LCD display area | 34 mm*27.5mm | 39mm*39.5mm | |
| Meter Weight | 43.0± 5g with batteries | 81.0 ± 5g with batteries | |
| Color | white/gray | white/green |
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Discussion of Non-Clinical Tests Performed for Determination of Substantial 8. Equivalence is as follows:
Verification and validation of these blood glucose systems evaluated to establish the performance, functionality, and reliability of the Rightest Blood Glucose Monitoring System GM280, Rightest Blood Glucose Monitoring System GM280B, GE Blood Glucose Monitoring System 180, and GE Blood Glucose Monitoring System 182 Blood Glucose Monitoring Systems. The evaluation included precision, linearity, interference, sample volume and hematocrit.
9. Discussion of Clinical Tests Performed:
System Accuracy Study:
The system accuracy study of the Rightest Blood Glucose Monitoring System GM280 was performed by comparing capillary and venous whole blood (plasma equivalent) glucose values on the Rightest Blood Glucose Meter GM280 with glucose values on lab instrument YSI 2300 Plus Glucose Analyzer.
11
A total of 104 patients participated. The study results demonstrate that the accuracy of Rightest Blood Glucose Monitoring System GM280 met the acceptance criteria.
User Performance Study:
The user performance study was performed to demonstrate that English speaking and reading lay users across all educational backgrounds can easily understand and follow the labeling/user instructions to obtain accurate results while using Rightest Blood Glucose Monitoring System GM280B.
A total of 135 subjects participated. The study results demonstrate that the user accuracy and ease of use (via participant questionnaire scoring) Rightest Blood Glucose Monitoring System GM280B meet the acceptance criteria.
10. Conclusions:
Results of performance evaluation of the Rightest Blood Glucose Monitoring System GM280. Rightest Blood Glucose Monitoring System GM280B, GE Blood Glucose Monitoring System 180, and GE Blood Glucose Monitoring System 182 demonstrate that the devices are substantially equivalent to the predicate device, GE333 Blood Glucose Monitoring System.