(217 days)
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.
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.
Here's a breakdown of the acceptance criteria and study information for the Rightest Blood Glucose Monitoring System, Model GM310, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly state quantitative "acceptance criteria" in a separate section. Instead, the "Discussion of Non-Clinical Tests Performed" implicitly defines performance expectations through the tests conducted (precision, linearity, interference, hematocrit, control solution). The clinical study then demonstrates the device's accuracy against a laboratory reference.
Given the context of a blood glucose monitoring system, the primary acceptance criteria revolve around the agreement with a reference method, particularly in various sample locations. The "performance" is demonstrated by the linear regression results against the Olympus AU640.
Therefore, I will construct an acceptance criteria table based on the findings used to demonstrate substantial equivalence, focusing on the agreement with the reference method. The implied acceptance criterion is that the device should show "similarly slope and intercept" and a high correlation (r-value) compared to the reference method for all tested sites, demonstrating accuracy suitable for its intended use.
| Acceptance Criterion (Implied) | Reported Rightest Performance (vs. Olympus-Plasma) |
|---|---|
| Fingerstick | |
| Slope close to 1.0 | 0.99 |
| Intercept close to 0 | 0.67 |
| High Correlation (r-value) | 0.994 |
| Palmstick | |
| Slope close to 1.0 | 0.98 |
| Intercept close to 0 | 3.17 |
| High Correlation (r-value) | 0.995 |
| Armstick | |
| Slope close to 1.0 | 0.95 |
| Intercept close to 0 | 5.26 |
| High Correlation (r-value) | 0.985 |
| Test Range (mg/dL) | 20 - 600 mg/dL (Device Spec) |
| Precision (evaluated) | Evaluated, but no specific values reported |
| Linearity (evaluated) | Evaluated, but no specific values reported |
| Interference (tolerance for specific substances) | Uric acid > 9.0 mg/dL, Cholesterol > 500 mg/dL |
| Hematocrit Range | 30 - 55% |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 120 measurements for each site (fingerstick, palmstick, armstick), totaling 360 measurements.
- Data Provenance: The document does not explicitly state the country of origin for the clinical study data or whether it was retrospective or prospective. Given that the submitter's identification is BIONIME CORPORATION, TAICHUNG COUNTY, TAIWAN, it's possible the study was conducted within Taiwan, but this is not confirmed. The study appears to be a prospective clinical evaluation as it's designed to compare the device's performance against a reference.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The ground truth was established by a laboratory reference method, the Olympus AU640, which is an automated clinical chemistry analyzer. This machine provides the reference glucose values against which the Rightest system's readings were compared. Therefore, the ground truth was based on a highly accurate and calibrated laboratory instrument rather than individual human expert consensus. The involvement of "experts" would be related to operating and maintaining the Olympus AU640, typically qualified clinical laboratory technologists or specialists.
4. Adjudication Method for the Test Set
Not applicable. The ground truth was established by the Olympus AU640 laboratory analyzer. There was no mention of human adjudication for the primary glucose values.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a blood glucose monitoring system, not an imaging device typically evaluated with MRMC studies or AI assistance for human readers. It measures glucose directly.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance study was done. The reported performance metrics (slope, intercept, r-value) are directly comparing the device's output (Rightest Blood Glucose Monitoring System) against the laboratory reference (Olympus AU640), without any human interpretation or intervention in the measurement process itself. The "Test capillary blood by patient Study" refers to patients using the device to take samples, but the measurement output itself is the device's standalone performance.
7. The Type of Ground Truth Used
The ground truth used was laboratory reference data obtained from an Olympus AU640 analyzer. This is a highly accurate and standardized method for measuring blood glucose.
8. The Sample Size for the Training Set
The document does not provide any information regarding a "training set" or "validation set" in the context of machine learning or algorithm development. This type of submission (510(k) for a glucose meter) typically focuses on the performance of the final device and its inherent technology, rather than iterative algorithm training. The "non-clinical tests" (precision, linearity, interference, etc.) could be seen as part of the internal development and verification, but not explicitly a "training set" in the AI sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set (in the context of machine learning) is described or implied by the document. The device's underlying technology relies on electrochemical detection (amperometry) with glucose oxidase, and its performance is validated against laboratory-grade reference methods.
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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:
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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 DeviceRightest 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° F10 - 40° C | 50 - 104° F10 - 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 (SampleVolume/Reaction Time) | Predicate Device(s) |
| Rightest BGMS | Rightest BGMS(AST) |
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| Sample Source | The glucoseconcentration ismeasured withquantitative capillarywhole blood from thefingertip, palm andforearm by using RightestBlood GlucoseMonitoring System. | The glucoseconcentration ismeasured withquantitative capillarywhole blood from thefingertip, palm andforearm by using RightestBlood GlucoseMonitoring System. |
|---|---|---|
| Description andLabelling | We mention theinformation aboutmodification in user'smanual. We also show adiagrammatic explanationabout alternative test sitesin user's manual. | We mention theinformation aboutmodification in user'smanual. We also show adiagrammatic explanationabout alternative test sitesin 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 |
| Memorycapability | 1, 7, 14, 30 day averageand last 300 tests in thememory | 1, 7, 14, 30 day averageand last 300 tests in thememory |
| Battery life | Running 1,000 test | Running 1,000 test |
| The unit ofmeasurement data | Fix on mg/dL | Fix on mg/dL |
| Interference | Uric acid > 9.0 mg/dLCholesterol > 500 mg/dL | Uric acid > 9.0 mg/dLL-Doga > 1.5 ml/dLMethyldopa > 1.5 mg/dLCholesterol > 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.
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| Technician | Rightest fingerstick vsOlympus-Plasma | Rightest palmstick vsOlympus-Plasma | Rightest armstick vsOlympus-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 |
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.
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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).
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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.
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
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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
Page 1 of _
§ 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.