(118 days)
Not Found
No
The summary describes a standard blood glucose monitoring system and test strips, with no mention of AI or ML in the intended use, device description, or performance studies.
No.
This device is a blood glucose monitoring system used for quantitative measurement of glucose, which is a diagnostic tool, not a therapeutic device. It aids in monitoring diabetes but does not treat the condition.
No
The "Intended Use / Indications for Use" section explicitly states for all variations of the GAL-1E system that "It is not indicated for the diagnosis or screening of diabetes or for neonatal use." This indicates it is for monitoring, not diagnosis.
No
The device description explicitly mentions a "blood glucose meter" and "test strips," which are hardware components. The summary also details non-clinical testing related to hardware (EMC, Electrical Safety, drop testing, disinfection performance).
Yes, this device is an IVD (In Vitro Diagnostic).
The intended use statements for all variations of the GAL-1E system explicitly state:
- "Testing is done outside the body (In Vitro diagnostic use)."
This phrase directly indicates that the device is intended for use in vitro, which is the definition of an IVD. The device measures glucose in blood samples, which are biological specimens taken from the body, and the testing is performed outside the body.
N/A
Intended Use / Indications for Use
GAL-1E Blood Glucose Monitoring System
The GAL-1E 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.
GAL-1E Blood Glucose Test Strips
The GAL-1E Blood Glucose Test Strips are to be used with the GAL-1E 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.
GAL-1E Multi Blood Glucose Monitoring System
The GAL-1E Multi 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 to be used for multiple patients in a clinical setting by healthcare professionals, as an aid to monitoring levels in Diabetes Mellitus. This system is only used with single-use, auto-disabling lancing device. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.
GAL-1E Multi Blood Glucose Test Strips
The GAL-1E Multi Blood Glucose Test Strips are to be used with the GAL-1E Multi 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. They are indicated in a clinical setting to be used for multiple patients by healthcare professionals. This system is only used with single-use, auto-disabling lancing devices.
Product codes (comma separated list FDA assigned to the subject device)
CGA, NBW
Device Description
The GAL-1E blood glucose meter and GAL-1E test strips are used for testing of blood glucose. There is one version for self-testers at home and a second version ("GAL-1E Multi") for professional use. Contrex Plus III Glucose Control Solutions are used for quality control testing of the systems.
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
GAL-1E Blood Glucose Monitoring System: lay use by people with diabetes
GAL-1E Multi Blood Glucose Monitoring System: healthcare professionals in a clinical setting
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: EMC and Electrical Safety, drop testing, disinfection performance (robustness of meter to multiple cleanings and disinfections), software verification and validation, and linearity testing with validation of Lo/Hi detection. Disinfection testing with Dispatch wipes was done using a Hepatitis B test model. Results demonstrate substantial equivalence to the predicate system.
Clinical Testing: An accuracy study was conducted with professional testing. User study data were discussed. Results demonstrate substantial equivalence to the predicate system.
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
MAR 2 8 2012
.
| 510(k) Summary | |
|---|---|
| Submitter: | Apex Biotechnology Corp. |
| No. 7, Li-Hsin Road V, Hsinchu Science Park | |
| Hsinchu, 30078 | |
| CHINA (TAIWAN) | |
| Contact Person: | Lisa Liu |
| Assistant Manager of Quality Assurance Department | |
| Apex Biotechnology Corp. | |
| No. 7, Li-Hsin Road V, Hsinchu Science Park | |
| Hsinchu, 30078 | |
| CHINA (TAIWAN) | |
| email: lisliu@apexbio.com | |
| Phone: 011-886-3-5641952, ext 567 | |
| Fax: 011-886-3-5678302 | |
| Date Prepared: | March 22, 2012 |
| Trade Names: | GAL-1E Blood Glucose Monitoring System |
| GAL-1E Blood Glucose Test Strips | |
| GAL-1E Multi Blood Glucose Monitoring System | |
| GAL-1E Multi Blood Glucose Test Strips | |
| Classification: | Glucose test system, 21 CFR 862.1345, Class II |
| Product Codes: | CGA, NBW |
| Predicate Device: | GAL-1C Blood Glucose Monitoring System (K102816) |
| GAL-1C Blood Glucose Test Strip (K102816) | |
| Device Description: | The GAL-1E blood glucose meter and GAL-1E test strips are used for |
| testing of blood glucose. There is one version for self-testers at home | |
| and a second version ("GAL-1E Multi") for professional use. Contrex | |
| Plus III Glucose Control Solutions are used for quality control testing of | |
| the systems. | |
| Intended Use: | |
| GAL-1E Blood Glucose Monitoring System | |
| The GAL-1E 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. | |
| GAL-1E Blood Glucose Test Strips | |
| The GAL-1E Blood Glucose Test Strips are to be used with the GAL- | |
| 1E 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. | |
| GAL-1E Multi Blood Glucose Monitoring System | |
| The GAL-1E Multi 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 to be used for multiple patients in a | |
| clinical setting by healthcare professionals, as an aid to monitoring | |
| levels in Diabetes Mellitus. This system is only used with single-use, | |
| auto-disabling lancing device. It is not indicated for the diagnosis or | |
| screening of diabetes or for neonatal use. | |
| GAL-1E Multi Blood Glucose Test Strips | |
| The GAL-1E Multi Blood Glucose Test Strips are to be used with the | |
| GAL-1E Multi 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. They are | |
| indicated in a clinical setting to be used for multiple patients by | |
| healthcare professionals. This system is only used with single-use, auto- | |
| disabling lancing devices. |
1
510(k) Summary (Continued)
2
510(k) Summary (Continued)
| Comparison of
Technological
Characteristics: | The GAL-1E and GAL-1E Multi meters have been modified relative to
the predicate by orienting the Liquid Crystal Display (LCD) vertically
and rearranging its icons, adding a strip ejection button, plus altering the
meter case to accommodate the LCD change. The GAL-1E and GAL-
IE Multi meters use the same test algorithm as the predicate meter. The
GAL-IE and GAL-IE Multi test strips are identical to their predicate
devices. |
|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Non-Clinical
Testing: | Testing was conducted as follows: EMC and Electrical Safety, drop
testing, disinfection performance (robustness of meter to multiple
cleanings and disinfections), software verification and validation, and
linearity testing with validation of Lo/Hi detection. Disinfection testing
with Dispatch wipes was done using a Hepatitis B test model. Results
demonstrate substantial equivalence to the predicate system. |
| Clinical Testing | An accuracy study was conducted with professional testing. User study
data were discussed. Results demonstrate substantial equivalence to the
predicate system. |
| Conclusion: | Clinical and non-clinical testing demonstrated that the GAL-IE, and
GAL-1E Multi, systems perform in a substantially equivalent manner to
that of the predicate. We conclude that the GAL-1E and GAL-1E Multi
systems are substantially equivalent to the predicate system. |
.
.
.
.
:
3
Image /page/3/Picture/11 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract image of an eagle with three lines representing its head and wings. The seal is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
10903 New Hampshire Avenue Silver Spring, MD 20993
MAR 2 8 2012
Apex Biotechnology Corp. c/o Dr. Bruce A. MacFarlane Senior Principal Scientist 4050 Olson Memorial Hwy, Suite 450 Minneapolis, MN, 55422 USA
Re: K113547 GAL-1E Blood Glucose Monitoring System and GAL-1E Multi Blood Trade/Device Name: Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: II Product Code: CGA, NBW Dated: March 22, 2012 Received: March 23, 2012
Dear Dr. MacFarlane,
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).
4
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro 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/Medical
Devices/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/Resourcesfor You/Industry/default.htm
Sincerely yours,
signature
Counney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
510(k) Number (if known): K113547
Device Name: GAL-1E Blood Glucose Monitoring System
Indications for Use:
The GAL-IE 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-IE Blood Glucose Test Strips are to be used with the GAL-1E 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.
Over-The-Counter Use Prescription Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (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) k113(4)
Page 1 of 2
6
Indications for Use Statement
510(k) Number (if known): K113547
Device Name: GAL-1E Multi Blood Glucose Monitoring System
Indications for Use:
The GAL-1E Multi 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 to be used for multiple patients in a clinical setting by healthcare professionals, as an aid to monitoring levels in Diabetes Mellius. This system is only used with single-use, auto-disabling lancing device. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.
The GAL-IE Multi Blood Glucose Test Strips are to be used with the GAL-IE Multi 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. They are indicated in a clinical setting to be used for multiple patients by healthcare professionals. This system is only used with single-use, auto-disabling lancing devices.
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)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) k 113547
Page 2 of 2