(318 days)
Not Found
No
The document describes a standard blood glucose monitoring system and does not mention any AI or ML components in the device description, intended use, or performance studies.
No
The device is a blood glucose monitoring system, which is used for diagnostic purposes (monitoring blood glucose levels) and not for treating a disease or condition.
No
The intended use explicitly states, "It is not indicated for the diagnosis or screening of diabetes." It is instead an aid for monitoring blood glucose levels.
No
The device description explicitly states that the system consists of a "meter" and "test strips," which are hardware components.
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 statement directly identifies the device as an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The GAL-1F 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 blood glucose 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-1F Pro 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 blood glucose levels in Diabetes Mellitus. This system is only used with single-use, auto-disabling lancets. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.
Product codes
CGA, NBW
Device Description
The GAL-1F blood glucose monitoring system consists of the GAL-1F meter and GAL-1F Test Strips. It is used for testing of blood glucose by self-testers at home. The GAL-1F Pro blood glucose monitoring system consists of the GAL-1F Pro meter and GAL-1F Pro Test Strips. It is used for testing of blood glucose by professional testers in healthcare facilities. The GAL-1F and GAL-1F Pro systems are identical other than trade names and details of product labeling.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
fingertips, forearm, or palm
Indicated Patient Age Range
Not Found
Intended User / Care Setting
GAL-1F Blood Glucose Monitoring System: lay use by people with diabetes, at home.
GAL-1F Pro Blood Glucose Monitoring System: multiple patients in a clinical setting by healthcare professionals.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
An accuracy user study was performed with blood testing by 114 self-testers and with professional testing. 106 unaltered samples were tested by self-testers. An Ease-of-Use and Ease-of-Understanding (of the instructions for use) questionnaire were administered.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing: Software verification and validation, linearity and detection limit testing, EMC and Electrical Safety testing, and drop testing were done. Disinfection and "robustness” testing were done to qualify several recommended disinfection solutions. Results demonstrate substantial equivalence to the predicate device.
Clinical Testing: An accuracy user study was performed with blood testing by 114 self-testers and with professional testing. 106 unaltered samples were tested by self-testers. An Ease-of-Use and Ease-of-Understanding (of the instructions for use) questionnaire were administered. Results demonstrate substantial equivalence to the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three overlapping wing-like shapes.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 6, 2015
APEX BIOTECHNOLOGY CORP. HSUE-MEI LEE MANAGER OF QUALITY ASSURANCE DEPARTMENT NO. 7, LI-HSIN RD. V, HSINCHU SCIENCE PARK HSINCHU, TAIWAN, ROC
Re: K142689
Trade/Device Name: GAL-1F Blood Glucose Monitoring System. GAL-1F Pro Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: CGA, NBW Dated: July 7, 2015 Received: July 8, 2015
Dear Hsue-Mei Lee:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Courtney H. Lias -S
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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| SEDIVALS MAMUH GHA HEATH AND SERVICES | Form Approved: OMB No. 0910-0120 |
|---|---|
| ndications for Use | |
| Food and Drug Administration | ee PRA Statement below. |
| xpiration Date: January 31, 2017 | |
| 510(k) Number (if known | |
| R142689 | |
| GAL-IF Blood Glucose Monitoring System | |
| Device Name | |
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| Indications for Use (Describe) | |
| for neonatal use. | |
| bloods on by use by people with dideces, as an aid to monitoring blood glucose levels in Diabes Mellitus and sould | |
| Type of Use (Select one or both, as applicable) | |
| Prescription Use (Part 21 CFFR 801 Subpart D | Dover-The-Counter Use (S) CFR 801 Suppart C) |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| A WOJER SEARCOA JIANNER FORTED TO THE PROPERT OT MARC TOM OD | |
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| of this information collection, including suggestions for reducing to: | |
| The but in the filled of the collection is selling of in the collections of the forms of the forms of the forms of the | |
| Paperwork Reduction Act (PRA) Stati | |
| Office of Chief Information Officer | |
| Food and Drug Administration | |
| Department of Health and Human Services | |
| PASSISTOpydathhs.gov | |
| "," bounce may hot coupled or sponsor, and a person is not to a prospond to, a collection of | |
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| FORREFDR 3881 (8144444 | |
| Page 1 of 1 | PSC Publishing Services (301) 443-6740 |
| ਜ ਤੋਂ |
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3
| DEPARTMENT OF HEALTH AND HUMMA SERVICES
Food and Drug Administration | Form Approved: OMB No. 0810-0120
piration Date: January 31, 2017 |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|
| ndications for Us | ee PRA Statement below. |
| R142689
510(k) Number (if known | |
| GAL-IF Pro Blood Glucose Monitoring System
Device Name | |
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Page 1 of 1 | PSC Prablishing Services (301) 443-6740
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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 | Aug 04, 2015 |
| Trade Names | GAL-1F Blood Glucose Monitoring System
GAL-1F Blood Glucose Test Strips
GAL-1F Pro Blood Glucose Monitoring
GAL-1F Pro Blood Glucose Test Strips |
| Classification | Glucose test system, 21 CFR 862.1345, Class II |
| Product Codes | CGA, NBW |
| Predicate Devices | GAL-1E and GAL-1E Multi (K113547) Blood Glucose Monitoring Systems |
| Device Description | The GAL-1F blood glucose monitoring system consists of the GAL-1F meter
and GAL-1F Test Strips. It is used for testing of blood glucose by self-testers at
home. The GAL-1F Pro blood glucose monitoring system consists of the
GAL-1F Pro meter and GAL-1F Pro Test Strips. It is used for testing of blood
glucose by professional testers in healthcare facilities. The GAL-1F and GAL-
1F Pro systems are identical other than trade names and details of product
labeling. |
| Intended Use | The GAL-1F 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 blood glucose 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-1F Pro 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 blood glucose levels in
Diabetes Mellitus. This system is only used with single-use, auto-disabling lancets. It is
not indicated for the diagnosis or screening of diabetes or for neonatal use. |
| Comparison of
Technological
Characteristics | The GAL-1F and GAL-1F Pro meters uses the same test strip, test strip holder, and test
algorithm as the predicate. The test strip holder has been moved from the top of the
predicate meter to the bottom of the new meter and the test strip ejection mechanism of
the predicate has been eliminated. Software has been modified to support data
download functionality. |
| Non-Clinical
Testing | Software verification and validation, linearity and detection limit testing, EMC and
Electrical Safety testing, and drop testing were done. Disinfection and "robustness”
testing were done to qualify several recommended disinfection solutions. Results
demonstrate substantial equivalence to the predicate device. |
| Clinical Testing | An accuracy user study was performed with blood testing by 114 self-testers and with
professional testing. 106 unaltered samples were tested by self-testers. An Ease-of-Use
and Ease-of-Understanding (of the instructions for use) questionnaire were
administered. Results demonstrate substantial equivalence to the predicate. |
| Conclusion | Clinical and non-clinical testing show that the GAL-1F / GAL-1F Pro Blood Glucose
Monitoring System perform in a substantially equivalent manner to that of the
predicate device. |
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