(217 days)
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No
The summary describes a standard blood glucose monitoring system using test strips and a meter to measure glucose concentration. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is intended for aiding diabetes management by measuring glucose concentration, which is a therapeutic purpose.
Yes
The device is intended for "in vitro diagnostic use" and is used to "measure the glucose concentration" for aiding diabetes management, which directly points to its role in diagnosis and monitoring of a health condition.
No
The device description explicitly lists hardware components such as a Meter, Blood Glucose Test Strips, Code Key, Check key, Two Control Solutions, Lancing Device, and lancets.
Yes, based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement in Intended Use: The very first sentence of 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)."
- Measurement of Analyte in Biological Sample: The device measures the "glucose concentration" in "capillary whole blood from fingertip, palm and forearm." This is a classic characteristic of an IVD – analyzing a biological sample to provide diagnostic information.
- Aiding Diabetes Management: The intended use specifies that the measurement is for "aiding diabetes management," which is a diagnostic purpose.
Therefore, the device meets the definition of an In Vitro Diagnostic device.
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
NBW, CGA
Device Description
Our Blood Glucose Monitoring System consists of a Meter, Blood Glucose Test Strips, Code Key, Check key, Two Control Solutions, Lancing Device and lancets.
The Rightest Meter, Blood Glucose Test Strips, Code Key and Check key are manufactured by BIONIME Corporation. The Rightest Meter, when used with the Rightest Test Strips Blood Glucose Test Strips, quantitatively measures glucose in fresh capillary whole blood. The performance of the Rightest Blood Glucose Test Strips is verified by the Control Solution. The Check key verifies the status of Rightest meter.
Mentions image processing
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Mentions AI, DNN, or ML
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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
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 by patient Study: It shows similarly slope and intercept for difference position of capillary blood test by patient.
| Technician | Rightest fingerstick vs Olympus-Plasma | Rightest palmstick vs Olympus-Plasma | Rightest armstick vs Olympus-Plasma |
|---|---|---|---|
| Test range (mg/dL) | 32~590 | 31~564 | 34~582 |
| Test number | 120 | 120 | 120 |
| Slope | 0.99 | 0.98 | 0.95 |
| Intercept | 0.67 | 3.17 | 5.26 |
| r | 0.994 | 0.995 | 0.985 |
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 AU640. So the result tells us Rightest blood glucose monitoring system (Sample volume/Reaction Time) is suitable to be used in finger, palm and arm.
Key Metrics
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Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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:_Ko72.054
- Submitter's Identification: 1.
11 28
BIONIME CORPORRATION NO 694, RENHUA ROAD, DALI CITY, TAICHUNG COUNTY, TAIWAN 412 Contact Person: Mr. Roy Huang Phone Number: 886-4-24951268 FAX Number: 886-4-24952568
Date Summary Prepared: September 10, 2007
2. Name of the Device: Rightest Blood Glucose Monitoring System, Model GM310
-
- 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: 4.
Our Blood Glucose Monitoring System consists of a Meter, Blood Glucose Test Strips, Code Key, Check key, Two Control Solutions, Lancing Device and lancets.
The Rightest Meter, Blood Glucose Test Strips, Code Key and Check key are manufactured by BIONIME Corporation. The Rightest Meter, when used with the Rightest Test Strips Blood Glucose Test Strips, quantitatively measures glucose in fresh capillary whole blood. The performance of the Rightest Blood Glucose Test Strips is verified by the Control Solution. The Check key verifies the status of Rightest meter.
-
- 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
- Intended Use:
1
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.
-
- Predicate Device Information:
The Rightest Blood Glucose Monitoring System (Sample volume/Reaction Time) is substantially equivalent to the brand of Rightest Blood Glucose Monitoring System (Alternative Site Testing) noted below.
- Predicate Device Information:
| Name: | Rightest Blood Glucose Monitoring System |
|---|---|
| Device Company: | Bionime Corporation |
| 510(K) Number: | K042678, K053635 and K062567 |
7. Comparison to Predicate Devices:
| Similarities | ||
|---|---|---|
| Item | Subject Device | |
| Rightest BGMS | ||
| (Sample volume/Reaction Time) | Predicate Device(s) | |
| 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 |
| Coding | Code key | Code key |
| Power | 1.5V×2 battery (LR03) | 1.5V×2 battery (LR03) |
| Differences | ||
|---|---|---|
| Item | Subject Device (Sample | |
| Volume/Reaction Time) | Predicate Device(s) | |
| Rightest BGMS | Rightest BGMS(AST) |
2
| 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. |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Description and
Labelling | We mention the
information about
modification in user's
manual. We also show a
diagrammatic explanation
about alternative test sites
in user's manual. | We mention the
information about
modification in user's
manual. We also show a
diagrammatic explanation
about alternative test sites
in user's manual. |
| Test range | 20 - 600 mg/dL | 20 - 600 mg/dL |
| Test Time | 5 seconds | 8 seconds |
| Sample Volume | 0.5 uL | 1.4 uL |
| Memory
capability | 1, 7, 14, 30 day average
and last 300 tests in the
memory | 1, 7, 14, 30 day average
and last 300 tests in the
memory |
| Battery life | Running 1,000 test | Running 1,000 test |
| The unit of
measurement data | Fix on mg/dL | Fix on mg/dL |
| Interference | Uric acid > 9.0 mg/dL
Cholesterol > 500 mg/dL | Uric acid > 9.0 mg/dL
L-Doga > 1.5 ml/dL
Methyldopa > 1.5 mg/dL
Cholesterol > 250 mg/dL |
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: 9.
The clinical test was designed in Alternative site testing study as below
Test capillary blood by patient Study:
It shows similarly slope and intercept for difference position of capillary blood test by patient.
3
| Technician | Rightest fingerstick vs
Olympus-Plasma | Rightest palmstick vs
Olympus-Plasma | Rightest armstick vs
Olympus-Plasma |
|--------------------|-------------------------------------------|-----------------------------------------|----------------------------------------|
| Test range (mg/dL) | 32590 | 31564 | 34~582 |
| Test number | 120 | 120 | 120 |
| Slope | 0.99 | 0.98 | 0.95 |
| Intercept | 0.67 | 3.17 | 5.26 |
| r | 0.994 | 0.995 | 0.985 |
Fig 1 Linear regression from Rightest versus Olympus AU640
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 AU640. So the result tells us Rightest blood glucose monitoring system (Sample volume/Reaction Time) is suitable to be used in finger, palm and arm.
10. Conclusions:
Results of clinical testing demonstrate that the performance of the Rightest Blood Glucose Monitoring System (Sample volume/Reaction Time) 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 manaqement at home and in clinical settings.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black.
Public Health Service
FEB 2 8 2008
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Bionime Corporation c/o Ms. Susan D. Goldstein-Falk, Official Correspondent MDI Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, NY 11021
Re: K072054
Trade/Device Name: Rightest Blood Glucose Monitoring System Model GM310 Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose test system. Regulatory Class: Class II Product Code: NBW, CGA Dated: January 23, 2008 Received: January 24, 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 (OS) regulation (21 CFR Part 820).
5
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.
Yéan 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): K072054
Rightest Blood Glucose Monitoring System, Model GM310 Device Name:
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
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