(352 days)
K073648, 100747
K073648, 100747
No
The summary describes a standard blood glucose monitoring system and does not mention any AI or ML components in its description, intended use, or performance studies.
No.
Explanation: The device is intended for "quantitative measurement of glucose" and "aid to monitoring levels in Diabetes Mellitus." It is an in vitro diagnostic device used for measurement and monitoring, not for providing therapy or treatment.
No
The device is explicitly stated as "It is not indicated for the diagnosis or screening of diabetes". Its purpose is to aid in monitoring glucose levels for people already diagnosed with diabetes.
No
The device description explicitly mentions a "blood glucose meter" and "test strips," which are hardware components. The performance studies also include hardware-related testing like drop testing, EMC, electrical safety, and battery life.
Yes, this device is an IVD (In Vitro Diagnostic).
The intended use explicitly states: "Testing is done outside the body (In Vitro diagnostic use)." This is the defining characteristic of an IVD. The device measures glucose in blood samples outside of the patient's body to provide information about their health status.
N/A
Intended Use / Indications for Use
The GAL-1C Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (In Vitro diagnostic use). It is indicated for lay use by people with diabetes, as an aid to monitoring levels in Diabetes Mellitus and should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.
The GAL-1C Blood Glucose Test Strips are to be used with the GAL-1C Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). They are not indicated for the diagnosis or screening of diabetes or for neonatal use.
The purpose of the control solution test is to validate the performance of the Blood Glucose Monitoring System using a testing solution with a known range of glucose. A control test that falls within the acceptable range indicates the user's technique is appropriate and the test strip and meter are functioning properly.
Product codes
CGA, NBW, JJX
Device Description
The GAL-1C blood glucose meter and GAL-1C test strips used for testing of blood glucose by self-testers at home with Contrex Plus III Glucose Control Solutions for quality control testing
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertips, forearm, or palm
Indicated Patient Age Range
Not Found
Intended User / Care Setting
lay use by people with diabetes, 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing: Testing was conducted as follows: Software verification and validation, software integration, linearity, Lo/Hi detection, drop testing, EMC and Electrical Safety, verification of strip noninterchangeability between new and predicate devices, precision, interferences, minimum sample volume, altitude, hematocrit, humidity and temperature, control solution qualification, environmental conditions testing, test strip shelf life and use life, control solution shelf life and use life, and battery life testing. Disinfection testing was done to show that the system remained accurate after multiple disinfections to simulate a life time of disinfection treatments. Evaluation was done to demonstrate the ability of the selected disinfectant material to inactive Hepatitis B. Results demonstrate substantial equivalence to the predicate device meter, test strips, and control solutions.
Clinical Testing: An accuracy study was performed with blood testing by healthcare professionals. A User Performance study was conducted with self-testing at finger, palm, and forearm sites. A User Study was conducted to evaluate ease-of-use of the system and ease-of-understanding of the User's Manual. Results demonstrate substantial equivalence to the predicate system.
Conclusion: Clinical and non-clinical testing demonstrated that the GAL-1C system performs in a substantially equivalent manner to that of the predicate system. We conclude that the GAL-1C meter and GAL-1C test strips are substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K073648, 100747
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
. SEP 1 5 2011
| 510(k) Summary | |
|---|---|
| Submitter: | Hsue-mei Lee |
| Manager of Quality Assurance Department | |
| Apex BioTechnology Corp. | |
| No. 7, Li-Hsin Road V, Hsinchu Science Park | |
| Hsinchu, 30078 | |
| CHINA (TAIWAN) |
email: hsue-mei@apexbio.com
Phone: 011-886-3-5641952
FAX: 011-886-3-5678302 |
| Contact Person: | Hsue-mei Lee
Manager of Quality Assurance Department
Apex BioTechnology Corp.
No. 7, Li-Hsin Road V, Hsinchu Science Park
Hsinchu, 30078
CHINA (TAIWAN)
email: hsue-mei@apexbio.com
Phone: 011-886-3-5641952
FAX: 011-886-3-5678302 |
| Date Prepared: | September 13, 2011 |
| Trade Names: | GAL-1C Blood Glucose Monitoring System
GAL-1C Blood Glucose Test Strips
Contrex Plus III Glucose Control Solution |
| Classification: | Glucose test system, 21 CFR 862.1345, Class II
Single (specified) analyte controls (assayed and unassayed), 21 CFR
862.1660, Class I |
| Product Codes: | CGA, NBW, JJX |
| Predicate Device: | GlucoSure STAR Blood Glucose Monitoring System (K073648)
Contrex Plus Glucose Control Solution (100747) |
| Device Description: | The GAL-1C blood glucose meter and GAL-1C test strips used for
testing of blood glucose by self-testers at home with Contrex Plus III
Glucose Control Solutions for quality control testing |
| Intended Use: | The GAL-1C Blood Glucose Monitoring System is intended for the quantitative
measurement of glucose in fresh capillary whole blood samples drawn from the
fingertips, forearm, or palm. Alternative site testing should be performed only
during steady-state (when glucose is not changing rapidly). Testing is done outside
the body (In Vitro diagnostic use). It is indicated for lay use by people with
diabetes, as an aid to monitoring levels in Diabetes Mellitus and should only be used
by a single patient and it should not be shared. It is not indicated for the diagnosis or
screening of diabetes or for neonatal use.
The GAL-1C Blood Glucose Test Strips are to be used with the GAL-1C Blood
Glucose Meter to quantitatively measure glucose in capillary whole blood taken
from fingertips, palm, or forearm. Alternative site testing should be performed only
during steady-state (when glucose is not changing rapidly). They are not indicated
for the diagnosis or screening of diabetes or for neonatal use.
The purpose of the control solution test is to validate the performance of the Blood
Glucose Monitoring System using a testing solution with a known range of glucose.
A control test that falls within the acceptable range indicates the user's technique is
appropriate and the test strip and meter are functioning properly. |
| Comparison of
Technological
Characteristics: | The GAL-IC meter uses the same test algorithm as the predicate meter. The
GAL-1C meter has been modified by changing 4 operating buttons to 3
operating buttons. Meter software has been changed to accommodate the
new autocoding feature. The test strip holder has been modified to allow
automatic detection of the calibration code upon insertion of the test strip.
The test strip chemistry has been slightly modified and the blood collection
chamber has been reduced in volume. The Contrex Plus III Control Solution
includes an added red dye and slightly modified glucose concentrations. |
| Non-Clinical
Testing: | Testing was conducted as follows: Software verification and validation,
software integration, linearity, Lo/Hi detection, drop testing, EMC and
Electrical Safety, verification of strip noninterchangeability between new and
predicate devices, precision, interferences, minimum sample volume,
altitude, hematocrit, humidity and temperature, control solution qualification,
environmental conditions testing, test strip shelf life and use life, control
solution shelf life and use life, and battery life testing. Disinfection testing
was done to show that the system remained accurate after multiple
disinfections to simulate a life time of disinfection treatments. Evaluation
was done to demonstrate the ability of the selected disinfectant material to
inactive Hepatitis B. Results demonstrate substantial equivalence to the
predicate device meter, test strips, and control solutions. |
| Clinical Testing | An accuracy study was performed with blood testing by healthcare
professionals. A User Performance study was conducted with self-testing at
finger, palm, and forearm sites. A User Study was conducted to evaluate
ease-of-use of the system and ease-of-understanding of the User's Manual.
Results demonstrate substantial equivalence to the predicate system. |
| Conclusion: | Clinical and non-clinical testing demonstrated that the GAL-1C system
performs in a substantially equivalent manner to that of the predicate system.
We conclude that the GAL-1C meter and GAL-1C test strips are
substantially equivalent to the predicate devices. |
1
510(k) Summary (Continued)
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features three lines that resemble human figures, and a circle of text around the symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
Apex BioTechnology Corporation c/o IIsue-mei Lee Manager of Quality Assurance Department No. 7, Li-Hsin Road V, Hsinchu Science Park Hsinchu. 30078 China (Taiwan)
SEP 15 2011
Re: K102816
GAL-1C Blood Glucose Monitoring System, GAL-1C Blood Glucose Test Trade/Device Name: Strips, and Contrex Plus III Glucose Control Solutions Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, CGA, JJX Dated: August 22, 2011 Received: August 23, 2011
Dear Sir/Madam
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 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 nust comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807). Iabeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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.
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Page 2 -
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Viro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcessorYou/Industry/default.htm.
Sincerely yours,
signature
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): K102816
Device Name: GAL-IC Blood Glucose Monitoring System
Indications for Use:
GAL-1C Blood Glucose Monitoring System:
The GAL-1C Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (In 1 Vitro diagnostic use). It is indicated for lay use by people with diabetes, as an aid to monitoring levels in Diabetes Mellitus and should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.
GAL-1C Blood Glucose Test Strips:
The GAL-1C Blood Glucose Test Strips are to be used with the GAL-1C Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). They are not indicated for the diagnosis or screening of diabetes or for neonatal use.
Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K102816
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5
Indications for Use Statement
510(k) Number (if known): K102816
Device Name: Contrex Plus III Glucose Control Solutions
Indications for Use:
Intended use
The purpose of the control solution test is to validate the performance of the Blood Glucose Monitoring System using a testing solution with a known range of glucose. A control test that falls within the acceptable range indicates the user's technique is appropriate and the test strip and meter are functioning properly.
Over-The-Counter Use X = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = Prescription Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K102816
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