(106 days)
Not Found
No
The summary describes a standard blood glucose monitoring system and does not mention any AI or ML components. The performance studies focus on clinical validation of the measurement accuracy, not on the performance of an AI/ML algorithm.
No
The device is an in vitro diagnostic (IVD) device used for monitoring glucose levels, not directly treating or curing a disease.
Yes
The device is described as "an aid to monitoring levels in Diabetes Mellitus," which directly implies its use in diagnosing or monitoring a health condition.
No
The device description explicitly states that the GlucoSure Star system "consists of a meter, test strips, and control solutions," which are hardware components, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "Testing is done outside the body (In Vitro diagnostic use)." This is the defining characteristic of an IVD.
N/A
Intended Use / Indications for Use
"The GlucoSure Star Blood Glucose Monitoring System is intended for the quantitative measurement of qlucose in fresh capillary whole blood taken from fingertips, palm, or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for both lay use by people with diabetes and in a clinical setting by healthcare professionals, as an aid to monitoring levels in Diabetes Mellitus." The GlucoSure Star is identical to the GlucoTrack except for the addition of the palm and forearm sampling site claims.
Product codes
CGA, NBW, JJX
Device Description
GlucoSure Star consists of a meter, test strips, and control solutions for use in measuring blood glucose as an aid to monitor the effectiveness of diabetes control.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertips, palm, or forearm
Indicated Patient Age Range
Not Found
Intended User / Care Setting
lay use by people with diabetes and in a clinical setting by healthcare professionals
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
Clinical testing was done with persons with diabetes to verify proper performance for Alternate Site Testing (AST) using palm and forearm blood sampling. Professional fingertip meter results were compared with AST results collected both by professionals and by persons with diabetes. Data were analyzed by linear regression analysis, Clarke Error Grid analysis and bias analysis. Results met pass/fail performance criteria.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
APR 11.0 2008
5 510(k) Summary
| Submitter: | Thomas Y.S. Shen
Apex BioTechnology Corp.
No. 7, Li-Hsin Road V, Hsinchu Science Park
Hsinchu, 30078 CHINA (TAIWAN)
Phone: 011-886-3-5641952
FAX: 011-886-3-5678302 |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Thomas Y.S. Shen |
| Date Prepared: | December 21, 2007 |
| Trade Name: | GlucoSure Star Blood Glucose Monitoring System |
| Classification: | Glucose test system, 21 CFR 862.1345, Class II |
| Product Codes: | CGA, NBW, JJX |
| Predicate Device: | GlucoTrack Blood Glucose Monitoring System (K062799) |
| Device
Description: | GlucoSure Star consists of a meter, test strips, and control
solutions for use in measuring blood glucose as an aid to monitor
the effectiveness of diabetes control. |
| Intended Use: | "The GlucoSure Star Blood Glucose Monitoring System is
intended for the quantitative measurement of qlucose in fresh
capillary whole blood taken from fingertips, palm, or forearm.
Testing is done outside the body (In Vitro diagnostic use). It is
indicated for both lay use by people with diabetes and in a
clinical setting by healthcare professionals, as an aid to
monitoring levels in Diabetes Mellitus."
The GlucoSure Star is identical to the GlucoTrack except for the
addition of the palm and forearm sampling site claims. |
| Functional and
Safety Testing: | Clinical testing was done with persons with diabetes to verify
proper performance for Alternate Site Testing (AST) using palm
and forearm blood sampling. Professional fingertip meter results
were compared with AST results collected both by professionals
and by persons with diabetes. Data were analyzed by linear
regression analysis, Clarke Error Grid analysis and bias analysis.
Results met pass/fail performance criteria. |
| Conclusion: | The addition of the AST blood sampling claim does not adversely
affect performance of the device. The new device with the
modified AST blood sampling claim is substantially equivalent to
the predicate device with its original Intended Use. |
.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Apcx Biotechnology Corp. c/o Mr. Thomas Y. S. Shen Chairman & CEO No. 7, Li-Hsin Road V Hsinchu Science Park Hsinchu, 30078 Taiwan, ROC
APRIC 2008
Re: K073648
Trade Name: Glucosure Star Blood Glucose Monitoring System, Model as90000e1 Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Monitoring System Regulatory Class: Class II Product Codes: NBW, CGA Dated: February 21, 2008 Received: February 25, 2008
Dear Mr. Shen:
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) 276-0490. 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
3
Indications for Use Statement
510(k) Number (if known): ≤673648
Device Name: GlucoSure Star Blood Glucose Monitoring System
Indications For Use:
GlucoSure Star Blood Glucose Monitoring System:
The GlucoSure Star Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood taken from fingertips, palm, or forearm. Testing is done outside the body (In Vitro diagnostic use). The GlucoSure Star System is plasma-calibrated for easy comparison to lab results. It is indicated for both lay use by people with diabetes and in a clinical setting by healthcare professionals, as an aid to monitoring levels in Diabetes Mellitus.
GlucoSure Star Test Strips:
The GlucoSure Star Blood Glucose Test Strips are to be used with the GlucoSure Star Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
D/OR
Over-The-Counter Use
(21 CFR 801 Subpart C)
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Office of In Vitro Diagnostic Device Evaluation and Safety
S100(2) K073649