(111 days)
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No
The summary describes a standard blood glucose monitoring system using a meter and test strips, with no mention of AI, ML, or related concepts.
No
This device is for monitoring blood glucose levels, which aids in managing diabetes, but it does not directly treat the condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The Rightest Blood Glucose Monitoring System is intended for in vitro diagnostic use."
No
The device description explicitly lists hardware components such as a Meter, Blood Glucose Test Strips, Control Solutions, Lancing Device, and lancets.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "The Rightest Blood Glucose Monitoring System is intended for in vitro diagnostic use (outside of body)."
- Function: The device measures glucose concentration in blood samples, which is a diagnostic test performed outside of the body.
- Components: The system includes components like test strips and control solutions, which are typical for IVD devices.
N/A
Intended Use / Indications for Use
The Rightest Blood Glucose Monitoring System is intended for in vitro diagnostic use (outside of body). It is indicated to be used by professional healthcare personnel or people with diabetes at home to measure the glucose concentration for aiding diabetes management. The glucose concentration is measured with quantitative capillary whole blood from fingertip, palm and forearm by using Rightest Blood Glucose Monitoring System. This test device is not intended for testing neonate blood samples.
Special condition for use statement(s): Rightest system provides plasma equivalent results.
Product codes (comma separated list FDA assigned to the subject device)
NBW, CGA
Device Description
Our Blood Glucose Monitoring System consists of a Meter, Blood Glucose Test Strips, Two Control Solutions, Lancing Device and lancets. The Rightest Meter, Blood Glucose Test Strips are manufactured by BIONIME Corporation. The Rightest Meter, when used with the Rightest Test Strips, quantitatively measures glucose in fresh capillary whole blood. The performance of the Rightest Blood Glucose Monitoring System is verified by the Control Solution.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
fingertip, palm and forearm
Indicated Patient Age Range
This test device is not intended for testing neonate blood samples.
Intended User / Care Setting
professional healthcare personnel or people with diabetes at home
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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 Blood Glucose Monitoring System.
The evaluation included precision, linearity, interference, hematocrit and control solution.
The clinical test was designed in Alternative site testing study as below:
Test capillary blood Study: It shows similarly slope and intercept for difference position of capillary blood test.
| Technician | Rightest fingerstick vs Olympus-Plasma | Rightest palmstick vs Olympus-Plasma | Rightest armstick vs Olympus-Plasma |
|---|---|---|---|
| Test range (mg/dL) | 35~586 | 35~589 | 35~566 |
| Test number | 164 | 164 | 164 |
| Slope | 0.98 | 0.96 | 0.95 |
| Intercept | 2.13 | 9.80 | 2.82 |
| r | 0.991 | 0.990 | 0.990 |
The "Alternative Site Test" clinical evaluation shows substantial equivalence to Rightest used in finger, palm and arm position. They all have similar slope and intercept of Rightest value versus Olympus AU2700. So the result tells us Rightest blood glucose monitoring system, model GM110 is suitable to be used in fingertip, palm and forearm.
Results of clinical testing demonstrate that the performance of the Rightest Blood Glucose Monitoring System, model GM110 testing capillary whole blood is substantial equivalence of Rightest Blood Glucose Monitoring System (AST). The precision and accuracy of Rightest is suitable for its in monitoring the effectiveness of diabetes management at home and in clinical settings.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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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Exhibit 1
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is: 881450
-
- Submitter's Identification:
BIONIME CORPORRATION NO 694, RENHUA ROAD, DALI CITY, TAICHUNG COUNTY, TAIWAN 412 Contact Person: Mr. George Chi Phone Number: 886-4-24951268 FAX Number: 886-4-24952568
- Submitter's Identification:
Date Summary Prepared: July 13, 2007
- Name of the Device: Rightest Blood Glucose Monitoring System, Model GM110 2.
-
- Common or Usual Name: Glucose test system Panel: Clinical Chemistry 75 Product Code: NBW, System, Test, Blood Glucose, Over-the-Counter. Classification: Class II
-
- Device Description:
Our Blood Glucose Monitoring System consists of a Meter, Blood Glucose Test Strips, Two Control Solutions, Lancing Device and lancets. The Rightest Meter, Blood Glucose Test Strips are manufactured by BIONIME Corporation. The Rightest Meter, when used with the Rightest Test Strips, quantitatively measures glucose in fresh capillary whole blood. The performance of the Rightest Blood Glucose Monitoring System is verified by the Control Solution.
-
- Intended Use:
The Rightest Blood Glucose Monitoring System is intended for in vitro diagnostic use (outside of body). It is indicated to be used by professional healthcare personnel or people with diabetes at home to measure the glucose concentration for aiding diabetes management. The glucose concentration is measured with quantitative capillary whole blood from fingertip, palm and forearm by using Rightest Blood Glucose Monitoring System. This test device is not intended for testing neonate blood samples.
- Intended Use:
1
Special condition for use statement(s): Rightest system provides plasma equivalent results.
-
- Predicate Device Information:
The Rightest Blood Glucose Monitoring System, model GM110 is substantially equivalent to the brand of Rightest Blood Glucose Monitoring System (Alternative Site Testing) noted below.
- Predicate Device Information:
Rightest Blood Glucose Monitoring System, model GM110 Name: Device Company: Bionime Corporation 510(K) Number: K042678, K053635 and K062567
| Comparison to Predicate Devices: | НИНИЕ В А ПРИВИНИЯ НА ВИНИНИИ В МИНИНИИ В ИНИНИНИЕ В НАС ПРОДОДЕЛА НА СЕДА С | |
|---|---|---|
| Comments of the American Comments of |
| Similarities | ||
|---|---|---|
| Item | Subject Device | Predicate Device(s) |
| Rightest BGMS GM110 | ||
| (Alternative Site Testing) | Rightest BGMS | |
| (Alternative Site Testing) | ||
| Detection method | Amperometry | Amperometry |
| Enzyme | Glucose Oxidase | |
| (Aspergillus niger) | Glucose Oxidase | |
| (Aspergillus niger) | ||
| Mediator | Potassium ferricyanide | Potassium ferricyanide |
| Hematocrit Range | 30 - 55% | 30 - 55% |
| Temperature range | 50 - 104° F | |
| 10 - 40° C | 50 - 104° F | |
| 10 - 40° C | ||
| Humidity range | 10 - 90% | 10 - 90% |
| Warranty(meter) | 3 years | 3 years |
| Open use time | ||
| (strip) | 3 months | 3 months |
| Electrode | Noble metal electrode | Noble metal electrode |
| Test range | 20 - 600 mg/dL | 20 - 600 mg/dL |
| Test Time | 8 seconds | 8 seconds |
| Sample Volume | 1.4 uL | 1.4 uL |
| Sample Source | The glucose | |
| concentration is | ||
| measured with | ||
| quantitative capillary | ||
| whole blood from the | ||
| fingertip, palm and | ||
| forearm by using Rightest | ||
| Blood Glucose | ||
| Monitoring System. | The glucose | |
| concentration is | ||
| measured with | ||
| quantitative capillary | ||
| whole blood from the | ||
| fingertip, palm and | ||
| forearm by using Rightest | ||
| Blood Glucose | ||
| Monitoring System. | ||
| The unit of | ||
| measurement data | Fix on mg/dL | Fix on mg/dL |
2
| Battery life | Running 1,000 test | Running 1,000 test |
|---|---|---|
| Differences | ||
|---|---|---|
| Item | Subject Device(s) | Predicate Device(s) |
| Rightest BGMS GM110 | ||
| (AST) | Rightest BGMS(AST) | |
| Description and | ||
| Labelling | We mention the | |
| information about | ||
| modification in user's | ||
| Instruction. We also show | ||
| a diagrammatic | ||
| explanation about | ||
| alternative test sites in | ||
| user's Instruction. | We mention the | |
| information about | ||
| modification in user's | ||
| manual. We also show a | ||
| diagrammatic explanation | ||
| about alternative test sites | ||
| in user's manual. | ||
| Coding | ||
| Interference | Code Selection | |
| Uric acid > 9.0 mg/dL | ||
| Cholesterol > 500 mg/dL | Code key | |
| Uric acid > 9.0 mg/dL | ||
| L-Doga > 1.5 ml/dL | ||
| Methyldopa > 1.5 mg/dL | ||
| Cholesterol > 250 mg/dL | ||
| Memory Capacity | 10 blood glucose test | |
| results with date and time | 300 blood glucose test | |
| results with date and time | ||
| Power Saving | Turn off automatically after | |
| 2 minutes | Turn off automatically after | |
| 3 minutes | ||
| Power Supply | One CR2032 battery | Two 1.5V(AAA) batteries |
8. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
Verification and validation of test results were evaluated to establish the performance, functionality and reliability of The Rightest Blood Glucose Monitoring System.
The evaluation included precision, linearity, interference, hematocrit and control solution.
- ு. Discussion of Clinical Tests Performed:
The clinical test was designed in Alternative site testing study as below
Test capillary blood Study: It shows similarly slope and intercept for difference position of capillary blood test.
3
| Technician | Rightest fingerstick vs
Olympus-Plasma | Rightest palmstick vs
Olympus-Plasma | Rightest armstick vs
Olympus-Plasma |
|--------------------|-------------------------------------------|-----------------------------------------|----------------------------------------|
| Test range (mg/dL) | 35586 | 35589 | 35~566 |
| Test number | 164 | 164 | 164 |
| Slope | 0.98 | 0.96 | 0.95 |
| Intercept | 2.13 | 9.80 | 2.82 |
| r | 0.991 | 0.990 | 0.990 |
Fig 1 Linear regression from Rightest versus Olympus AU2700
The "Alternative Site Test" clinical evaluation shows substantial equivalence to Rightest used in finger, palm and arm position. They all have similar slope and intercept of Rightest value versus Olympus AU2700. So the result tells us Rightest blood glucose monitoring system, model GM110 is suitable to be used in fingertip, palm and forearm.
10. Conclusions:
Results of clinical testing demonstrate that the performance of the Rightest Blood Glucose Monitoring System, model GM110 testing capillary whole blood is substantial equivalence of Rightest Blood Glucose Monitoring System (AST). The precision and accuracy of Rightest is suitable for its in monitoring the effectiveness of diabetes management at home and in clinical settings.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
DEPARTMENT OF HEALTH & HUMAN SERVICES - USA
Food and Druq Administration 2098 Gaither Road Rockville MD 20850
SEP 1 1 2008
Bionime Corporation, MDI Consultant, Inc. c/o Ms. Susan D. Goldstein-Falk Official Correspondent 55 Northern Blvd., Suite 200 Great Neck, NY 11021
Rc: K081450
Trade Name: Rightest Blood Glucose Monitoring System, Model GM110 Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Codes: NBW, CGA Dated: August 15, 2008 Received: August 18, 2008
Dear Ms. Goldstein-Falk:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Yean M. Cooper. M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known):
Device Name: Rightest Blood Glucose Monitoring System, Model GM110
Indications For Use:
The Rightest Blood Glucose Monitoring System is intended for in vitro diagnostic use (outside of body). It is indicated to be used by professional healthcare personnel or diabetics 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. This device is not intended for testing neonate blood samples.
Special conditions for use statement(s): Rightest System provides plasma equivalent results.
Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol C Benson
Division Sign-Off
Division Sign-O
Office of In Vitro Diagnostic Device Evaluation and Safety
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