(106 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard blood glucose monitoring technology.
No
The device is used for monitoring blood glucose levels (In Vitro diagnostic use) and is explicitly stated not to be for diagnosis, screening, or neonatal use, which characterizes it as a diagnostic rather than a therapeutic device.
No
The "Intended Use / Indications for Use" section explicitly states, "It is not indicated for the diagnosis or screening of diabetes or for neonatal use," indicating it's for monitoring, not diagnosis.
No
The device description explicitly states that the system is comprised of a "GAL-1A Plus Blood Glucose Meter" and "GAL-1A Blood Glucose Test Strips," which are hardware components.
Yes, based on the provided information, the GAL-1A Plus Blood Glucose Monitoring System is an IVD (In Vitro Diagnostic) device.
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "Testing is done outside the body (In Vitro diagnostic use)."
- Nature of the Test: The system measures glucose in blood samples, which is a common type of in vitro diagnostic test.
- Purpose: It is intended as an aid to monitoring levels in Diabetes Mellitus, which is a diagnostic purpose performed outside the body.
N/A
Intended Use / Indications for Use
GAL-1A Plus Blood Glucose Monitoring System: GAL-1A Plus Blood Glucose Monitoring System is comprised of the GAL-1A Plus Blood Glucose Meter, the GAL-1A Blood Glucose Test Strips.
The GAL-1A Plus 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.
Product codes
NBW
Device Description
The GAL-1A Plus blood glucose monitoring system consists of the GAL-1A Plus meter and GAL-1A Test Strips. It is used for testing of blood glucose by self-testers at home.
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: Disinfection performance (robustness of meter to multiple cleanings and disinfections) was conducted. Results demonstrate substantial equivalence to the predicate system.
Clinical Testing: No clinical testing was conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
GAL-1A Blood Glucose System (K113208)
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 29, 2022
Apex BioTechnology Corp. Lisa Liu Manager of Quality Assurance Department No. 7, Li-Hsin Road V, Hsinchu Science Park Hsinchu. 30078 China (Taiwan)
Re: K213887
Trade/Device Name: GAL-1A Plus Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: December 10, 2021 Received: December 13, 2021
Dear Lisa Liu:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Marianela Perez-Torres, Ph.D. Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213887
Device Name
GAL-1A Plus Blood Glucose Monitoring System
Indications for Use (Describe)
GAL-1A Plus Blood Glucose Monitoring System: GAL-1A Plus Blood Glucose Monitoring System is comprised of the GAL-1A Plus Blood Glucose Meter, the GAL-1A Blood Glucose Test Strips.
The GAL-1A Plus 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.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| 510(k) number | K213887 |
|---|---|
| Submitter | Apex Biotechnology Corp. |
| No. 7, Li-Hsin Road V, Hsinchu Science Park | |
| Hsinchu, 30078 | |
| CHINA (TAIWAN) | |
| Contact Person | Lisa Liu |
| Manager of Quality Assurance Division | |
| Apex Biotechnology Corp. | |
| No. 7, Li-Hsin Road V, Hsinchu Science Park | |
| Hsinchu, 30078 | |
| CHINA (TAIWAN) | |
| email: lisaliu@apexbio.com | |
| Phone: 011-886-3-5641952 | |
| FAX: 011-886-3-5678021 | |
| Date Prepared | November 30, 2021 |
| Trade Names | GAL-1A Plus Blood Glucose Monitoring System |
| Classification | Glucose test system, 21 CFR 862.1345, Class II |
| Product Codes | NBW |
| Predicate Devices | GAL-1A Blood Glucose System (K113208) |
| Device Description | The GAL-1A Plus blood glucose monitoring system consists of the GAL-1A Plus meter and GAL-1A Test Strips. It is used for testing of blood glucose by self-testers at home. |
| Intended Use | GAL-1A Plus Blood Glucose Monitoring System: GAL-1A Plus Blood Glucose Monitoring System is comprised of the GAL-1A Plus Blood Glucose Meter, the GAL-1A Blood Glucose Test Strips. |
| The GAL-1A Plus 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. | |
| Comparison of | |
| Technological | |
| Characteristics | The GAL-1A Plus Blood Glucose meter uses the same test strip and test |
| algorithm as the predicate. The changes was for | |
| Case shape change: Modify the shape of the meter from rectangle | |
| to oval. Dimensions of the meter were changed from 76Lx45Wx14H | |
| (mm) to 77Lx51Wx14H (mm). The color of case was changed from black and white to gray. | |
| Non-Clinical | |
| Testing | Disinfection performance (robustness of meter to multiple cleanings and |
| disinfections) was conducted. Results demonstrate substantial equivalence | |
| to the predicate system. | |
| Clinical Testing | No clinical testing was conducted. |
| Conclusion | Testing showed that the modified GAL-1A Plus Blood Glucose Monitoring |
| Systems are substantially equivalent to the predicate. |
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