(238 days)
No
The document describes a standard blood glucose monitoring system with voice functionality for accessibility. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices. The performance studies focus on disinfection and equivalence to a predicate device, not on algorithmic performance.
No
The device is an in vitro diagnostic (IVD) device used for monitoring blood glucose levels, not for treating a condition or restoring health.
No
The "Intended Use / Indications for Use" section explicitly states that the device "is not intended for the diagnosis or screening of diabetes." Its purpose is to aid in monitoring blood glucose levels.
No
The device description explicitly states 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:
- "It is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home..."
- "It is intended for multiple-patient use in professional healthcare settings as an aid in monitoring blood glucose levels in Diabetes Mellitus."
These statements clearly indicate that the device is used to test samples taken from the human body (blood) outside of the body to provide information about a physiological state (blood glucose levels related to diabetes), which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
AutoSure Voice II Blood Glucose Monitoring System: The AutoSure Voice II 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. The meter includes voice functionality to assist visually impaired users. It is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitoring blood glucose levels in diabetes mellitus. This system is for single-patient use only and should not be shared. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). It is not intended for the diagnosis or screening of diabetes or for neonatal use. The AutoSure Blood Glucose Test Strips are to be used with the AutoSure Voice II Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm.
AutoSure Voice II Pro Blood Glucose Monitoring System: The AutoSure Voice II 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. The meter includes voice functionality to assist visually impaired users. It is intended for multiple-patient use in professional healthcare settings as an aid in monitoring blood glucose levels in Diabetes Mellitus. This system should only be used with single-use auto-disabling lancing devices. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). It is not intended for the diagnosis or screening of diabetes or for neonatal use. The AutoSure Pro Blood Glucose Test Strips are to be used with the AutoSure Voice II Pro Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm.
Product codes
NBW, CGA
Device Description
The AutoSure Voice II Blood Glucose Monitoring System consists of the AutoSure Voice II Meter and AutoSure Blood Glucose Test Strips. It is used for testing of blood glucose by self-testers at home. The AutoSure Voice II Pro Blood Glucose Monitoring System consists of the AutoSure Voice II Pro Meter and AutoSure Pro Blood Glucose Test Strips. It is used for testing of blood glucose by professional testers in healthcare facilities. The AutoSure Voice II and AutoSure Voice II 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
Not Found
Anatomical Site
Fingertips, forearm, or palm
Indicated Patient Age Range
Not intended for neonatal use.
Intended User / Care Setting
AutoSure Voice II Blood Glucose Monitoring System: self-testers at home
AutoSure Voice II Pro Blood Glucose Monitoring System: professional testers in healthcare facilities
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
Non-Clinical Testing: Disinfection (viral inactivation) and "robustness" testing were done to qualify all recommended disinfection solutions. Results demonstrate substantial equivalence to the original (predicate) device.
Clinical Testing: No clinical testing was conducted.
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.
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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 an abstract symbol that resembles a stylized caduceus or a family of three figures.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 14, 2015
APEX BIOTECHNOLOGY CORP. HSUE-MEI LEE MANAGER OF QUALITY ASSURANCE DEPARTMENT NO. 7 LI-HSIN ROAD V, HSINCHU SCIENCE PARK HSINCHU, 30078, CHINA
Re: K150396
Trade/Device Name: AutoSure Voice II Blood Glucose Monitoring System AutoSure Voice II Pro Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, CGA Dated: September 11, 2015 Received: September 14, 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 (QS) regulation (21 CFR Part 820); and if applicable, the
1
electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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/Resourcesfor You/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,
Katherine Serrano -S
For : 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
2
| | DEPARTMENT OF FREALTH AND HUMMA SERVICES
Indications for Use
Food and Drug Administration | Form Approved: OMB No. 0910-0120
See PRA Statement below.
xpiration Date: January 31, 2017 |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number (if known
R150396 | | |
| AutoSure Voice II Blood Glucose Monitoring Systen
Device Name | | |
| Indications for Use (Describe | | |
| changing rapidy). It is not intended for the disensis or screening of disbetes or for neonatal use
assets and forme as an is to moring blood glucoses nellifits. This system is for single-paties inst
to assist visually impared users. It is intended for self-testing outside the by beadly with
The AutoSure Voice II Blood Glucose Monitoring System is intended for the quartifative measurement of glucose in | | only and should not be shared. Alternative site testing should be done only during steady-state times (when glucose is not
fresh cary whole blood samples drawn the fingerting, forsearm, or palm. The more includes voice finestonality |
| messure glucose in capillary whole blood taken from fingertips, palm, or forcarm | | The AutoSure Blood Glucose Test Strips are to be used with the AutoSure Voice II Blood Glucose Meter to quantititively |
| | | |
| Type of Use (Select one or both, as applicable) | I Prescription Use (Part 21 CFF 801 Subpart D | X Over-The-Counter Use (21 CFR 801 Suppart C |
| | CONTINUE ON A SEPARATE PAGE IF NEEDED | |
| | in setting so not of the Personice of the Pages work Peduction Act of the | |
| | of this information collection, including suggestions for reducing this purden, to:
WO WANT A SERIE YOUR CONTENT FOR THE PROFILE ADDRESS BELLO | time to reviews instructions, sestime data sources, gather and manufacturer in the
and review the collection of information. Send comments regarding of any other aspect
de on the senod served subor en established in the series and the mit not not not not not not only of the |
| | PRASISTIf@fdg.hhs.goo
Paperwork Reduction Act (PRA) State
Office of Chief Information Officer
Food and Drug Administration
Department of Health and Human Services | |
| | "," be genery my no conduct or sponsor, and a person is not respond to, a collection of
information unless it displays a currently valid OMB number." | |
| FOR FOR FOR 3888 (8114 | Page 1 of 1 | PSC Publishing Services (101) 443-6740
ਜਤੀ ਹੈ |
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| Form Approved: OMB No. 0910-0120 |
|---|
| Expiration Date: January 31, 2017 |
| See PRA Statement below. |
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
| 510(k) Number (if known) | K150396 |
|---|---|
| Device Name | AutoSure Voice II Pro Blood Glucose Monitoring System |
| Indications for Use (Describe) | The AutoSure Voice II 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. The meter includes voice functionality to assist visually impaired users. It is intended for multiple-patient use in professional healthcare settings as an aid in monitoring blood glucose levels in Diabetes Mellitus. This system should only be used with single-use auto-disabling lancing devices. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). It is not intended for the diagnosis or screening of diabetes or for neonatal use. |
| The AutoSure Pro Blood Glucose Test Strips are to be used with the AutoSure Voice II Pro Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm. | |
| Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
n r
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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 | October 12, 2015 |
| Trade Names | AutoSure Voice II Blood Glucose Monitoring System
AutoSure Voice II Pro Blood Glucose Monitoring System |
| Classification | Glucose test system, 21 CFR 862.1345, Class II |
| Product Codes | CGA, NBW |
| Predicate Device | AutoSure Voice II Blood Glucose Monitoring System and AutoSure Blood
Glucose Test Strips (K102037) |
| Device Description | The AutoSure Voice II Blood Glucose Monitoring System consists of the
AutoSure Voice II Meter and AutoSure Blood Glucose Test Strips. It is used
for testing of blood glucose by self-testers at home. The AutoSure Voice II
Pro Blood Glucose Monitoring System consists of the AutoSure Voice II Pro
Meter and AutoSure Pro Blood Glucose Test Strips. It is used for testing of
blood glucose by professional testers in healthcare facilities. The AutoSure
Voice II and AutoSure Voice II Pro systems are identical other than trade names
and details of product labeling. |
| | |
| | The AutoSure Voice II 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. The meter includes voice functionality to assist |
| | visually impaired users. It is intended for self-testing outside the body (in vitro |
| | diagnostic use) by people with diabetes at home as an aid to monitoring blood glucose |
| | levels in diabetes mellitus. This system is for single-patient use only and should not be |
| | shared. Alternative site testing should be done only during steady-state times (when |
| | glucose is not changing rapidly). It is not intended for the diagnosis or screening of |
| | diabetes or for neonatal use. |
| | The AutoSure Blood Glucose Test Strips are to be used with the AutoSure Voice II |
| | Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken |
| | from fingertips, palm, or forearm. |
| Intended Use | The AutoSure Voice II 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. The meter includes voice functionality to assist
visually impaired users. It is intended for multiple-patient use in professional
healthcare settings as an aid in monitoring blood glucose levels in Diabetes Mellitus.
This system should only be used with single-use auto-disabling lancing devices.
Alternative site testing should be done only during steady-state times (when glucose is
not changing rapidly). It is not intended for the diagnosis or screening of diabetes or for
neonatal use.
The AutoSure Pro Blood Glucose Test Strips are to be used with the AutoSure Voice I
Pro Blood Glucose Meter to quantitatively measure glucose in capillary whole blood
taken from fingertips, palm, or forearm. |
| Comparison of
Technological
Characteristics | The modified AutoSure Voice II and AutoSure Voice II Pro Blood Glucose Monitoring
Systems are identical to the original (predicate) system other than a) separation of the
self-testing and professional usage claims into two products and b) the
recommendation of four additional disinfectants in the User's Guides. |
| Non-Clinical
Testing | Disinfection (viral inactivation) and "robustness" testing were done to qualify all
recommended disinfection solutions. Results demonstrate substantial equivalence to
the original (predicate) device. |
| Clinical Testing | No clinical testing was conducted. |
| Conclusion | Testing showed that the modified AutoSure Voice II and AutoSure Voice II Pro Blood
Glucose Monitoring Systems are substantially equivalent to the original (predicate)
system. |
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