(54 days)
Not Found
No
The summary describes a standard blood glucose monitoring system that measures glucose concentration using test strips and a meter. There is no mention of AI or ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
This device is an in vitro diagnostic (IVD) device used to measure glucose concentration for aiding diabetes management, not to provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is "intended for in vitro diagnostic use" and is used "to measure the glucose concentration for aiding diabetes management," which directly aligns with the definition of a diagnostic device.
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, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The Rightest Blood Glucose Monitoring System is intended for in vitro diagnostic use (outside of body)." This is the primary indicator that the device is an IVD.
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 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 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 includes Meter, Blood Glucose Test Strips, Code Key, Check key, Two Control Solutions, Lancing Device and lancets. 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 Control Solution. The Check key verifies the status of Rightest meter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingertip, palm and forearm
Indicated Patient Age Range
This device is not intended for testing neonate blood samples.
Intended User / Care Setting
professional healthcare personnel or diabetics 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
The clinical test was designed in Alternative site testing study as Test capillary blood by technician Study: It shows similarly slope and intercept for difference position of capillary blood test by technician. Test number for fingerstick, palmstick, and armstick was 134, 134, and 132 respectively. Test capillary blood by patient Study: It shows similarly slope and intercept of difference positions of capillary blood test by Patient. Test number for fingerstick, palmstick, and armstick was 134, 133, and 132 respectively.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Tests: 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 with precision, linearity, interference, environment factors (ex. Temperature, humidity and altitude), hematocrit and control solution.
Clinical Tests: The clinical test was designed in Alternative site testing study.
Test capillary blood by technician Study:
Testing range: 55.7~490 mg/dL for all
Rightest fingerstick vs YSI-Plasma: Test number = 134, Slope = 1.03, Intercept = -1.63, r = 0.9852
Rightest palmstick vs YSI-Plasma: Test number = 134, Slope = 1.02, Intercept = 1.18, r = 0.9862
Rightest armstick vs YSI-Plasma: Test number = 132, Slope = 0.96, Intercept = 6.55, r = 0.9793
Test capillary blood by patient Study:
Testing range: 55.7~490 mg/dL
Rightest fingerstick vs YSI-Plasma: Test number = 134, Slope = 1.06, Intercept = 1.44
Rightest palmstick vs YSI-Plasma: Test number = 133, Slope = 1.03, Intercept = 0.20
Rightest armstick vs YSI-Plasma: Test number = 132, Slope = 0.99, Intercept = 3.42
Results of clinical testing demonstrate that the performance of the Rightest Blood Glucose Monitoring System (Alternative Site Testing) testing capillary whole blood is substantial equivalence of Rightest Blood Glucose Monitoring System. 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.)
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.
0
FEB 2 1 2006
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: K053635 .
1. Submitter's Identification:
BIONIME CORPORRATION NO 694, RENHUA ROAD, DALI CITY, TAICHUNG COUNTY, TAIWAN 412 Contact Person: Patrick Hsieh Phone Number: 886-4-24951268 FAX Number: 886-4-24952568
Date Summary Prepared: February 2, 2006
- Name of the Device: Rightest Blood Glucose Monitoring System 2.
- Common or Usual Name: Glucose test system 3. Panel: Clinical Chemistry 75 Product Code: NBW, System, Test, Blood Glucose, Over-The-Counter. Classification: Class II
4. Device Description:
Our Blood Glucose Monitoring System includes Meter, Blood Glucose Test Strips, Code Key, Check key, Two Control Solutions, Lancing Device and lancets.
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 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 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 condition for use statement(s): Rightest System provides plasma equivalent results.
- Intended Use:
-
Predicate Device Information: 6.
1
The Rightest Blood Glucose Monitoring System is substantially equivalent to the brand of Rightest Blood Glucose Monitoring System noted below.
| Name: | Rightest Blood Glucose Monitoring System |
|---|---|
| Device Company: | Bionime Corporation |
| 510(K) Number: | K042678 |
7. Comparison to Predicate Devices:
| Similarities | ||
|---|---|---|
| Item | Device | |
| Rightest(Alternative Site | ||
| Testing) | Predicate | |
| Rightest | ||
| Detection method | Amperometry | Amperometry |
| Enzyme | Glucose Oxidase | |
| (Aspergillus niger) | Glucose Oxidase | |
| (Aspergillus niger) | ||
| Mediator | Potassium ferricyanide | Potassium ferricyanide |
| Test range | 20 - 600 mg/dL | 20 - 600 mg/dL |
| 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 |
| Test Time | 15 seconds | 15 seconds |
| Sample Volume | 2 uL | 2 uL |
| Memory | ||
| capability | 3, 7, 14 day average and last | |
| 200 tests in the memory | 3, 7, 14 day average and last | |
| 200 tests in the memory | ||
| Power | 1.5V×2 battery (LR03) | 1.5V×2 battery (LR03) |
| Battery life | Running 1,500 test | Running 1.500 test |
| Differences | ||
| Item | Device(Alternative Site | |
| Testing) | Predicate | |
| Rightest | Rightest | |
| Sample Source | The glucose | |
| concentration is | ||
| measured with | ||
| quantitative capillary | ||
| whole blood from the | ||
| fingertip, palm and | The glucose | |
| concentration is | ||
| measured with | ||
| quantitative capillary | ||
| whole blood from the | ||
| fingertip by using |
2
| forearm by using Rightest
Blood Glucose
Monitoring System. | Rightest Blood Glucose
Monitoring System. | |
|------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|
| Description and
Labelling | We mention the
information about
alternative site testing in
user's manual and packing
box. We also show a
diagrammatic explanation
about alternative test sites
in user's manual. | We mention the
information in user's
manual. |
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 with precision, linearity, interference, environment factors (ex. Temperature, humidity and altitude), hematocrit and control solution.
9. Discussion of Clinical Tests Performed: The clinical test was designed in Alternative site testing study as below
The clinical test was designed in Alternative site testing study as
Test capillary blood by technician Study:
It shows similarly slope and intercept for difference position of capillary blood test by technician.
| Technician | Rightest fingerstick
vs YSI-Plasma | Rightest palmstick
vs YSI-Plasma | Rightest armstick
vs YSI-Plasma |
|---------------|---------------------------------------|-------------------------------------|------------------------------------|
| Testing range | 55.7490 mg/dL | 55.7490 mg/dL | 55.7~490 mg/dL |
| Test number | 134 | 134 | 132 |
| Slope | 1.03 | 1.02 | 0.96 |
| Intercept | -1.63 | 1.18 | 6.55 |
| r | 0.9852 | 0.9862 | 0.9793 |
Fig 1 Linear regression from Rightest versus YSI 2300D
Test capillary blood by patient Study:
It shows similarly slope and intercept of difference positions of capillary blood test by Patient.
Fig 2 Linear regression from Rightest versus YSI 2300D
| Technician | Rightest fingerstick
vs YSI-Plasma | Rightest palmstick
vs YSI-Plasma | Rightest armstick
vs YSI-Plasma |
|---------------|---------------------------------------|-------------------------------------|------------------------------------|
| Testing range | | 55.7 ~ 490 mg/dL | |
| Test number | 134 | 133 | 132 |
| Slope | 1.06 | 1.03 | 0.99 |
3
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The "Alternative Site Test" clinical evaluation shows substantially equivalent to Rightest used in finger, palm and arm position. They all have similar slope and intercept of Rightest value versus YSI 2300D. So the result tells us Rightest blood glucose monitoring system 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 (Alternative Site Testing) testing capillary whole blood is substantial equivalence of Rightest Blood Glucose Monitoring System. 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
Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, and three horizontal lines below the eagle. The text "U.S. Department of Health & Human Services - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 2 1 2006
Bionime Corporation c/o Ms. Susan D. Goldstein-Falk MDI Consultant, Inc. 55 Northern Blvd. Suite 200 Great Neck, NY 11201
Re: K053635
Trade/Device Name: Rightest Blood Glucose Monitoring System Regulation Number: 21 CFR§ 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW. CGA Dated: December 28, 2005 Received: December 29, 2005
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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Page 2 -
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) 276-0484. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Alberto Gutierrez, Ph.D.
Alberto Gutierrez, Ph.D. 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): K053635
Device Name: Rightest Blood Glucose Monitoring System
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 condition for use statement(s): Rightest System provides plasma equivalent results.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 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)
Ann Chappie
Division Sign-Off
Device I
Page 1 of
510(k)