(126 days)
Not Found
No
The summary does not mention AI, ML, or any related technologies. The voice functionality is described as an aid for visually impaired users, which is a feature, not necessarily an AI/ML application.
No.
The device is for monitoring glucose levels in diabetes, not for treating the condition.
No
The document explicitly states that the device "is not indicated for the diagnosis or screening of diabetes".
No
The device description explicitly states it includes a "blood glucose meter" and "test strips," which are hardware components. While it has voice functionality (likely software-driven), the core device is a physical meter.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative measurement of glucose in fresh capillary whole blood samples." This is a measurement performed in vitro (outside the body) on a biological sample (blood).
- Device Description: The description confirms it's used for "testing of blood glucose by self-testers at home," further reinforcing the in vitro nature of the test.
- Test Strips: The test strips are specifically designed to be used with the meter to measure glucose in blood, which is an in vitro process.
- Control Solutions: The mention of control solutions for quality control testing is also characteristic of IVD devices, as they are used to verify the accuracy of the in vitro test.
The fact that it's for "lay use by people with diabetes as an aid to monitoring levels" and not for diagnosis or screening doesn't change its classification as an IVD. IVDs can be used for monitoring, screening, diagnosis, or other purposes, as long as they involve testing biological samples in vitro.
N/A
Intended Use / Indications for Use
The AutoSure Voice 3 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. The meter includes voice functionality to assist visually impaired users. 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 AutoSure Plus Blood Glucose Test Strips are to be used with theAutoSure Voice 3 Plus Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm. They are not indicated for the diagnosis or screening of diabetes or for neonatal use.
Product codes
CGA, NBW
Device Description
The AutoSure Voice 3 Plus blood glucose meter and AutoSure Plus test strips are used for testing of blood glucose by self-testers at home. Contrex Plus III Glucose Control Solutions are used for quality control testing of the system.
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
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: EMC & Electrical Safety and linearity testing. Results demonstrate substantial equivalence to the predicate system.
Clinical Testing: A user survey shows substantial equivalence in ease-of-use after the relocation of the operation buttons.
Key Metrics
Not Found
Predicate Device(s)
AutoSure Voice II Plus Blood Glucose Monitoring System (K113098), AutoSure Plus Blood Glucose Test Strip (K113098 )
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
JUL
6 510(k) Summary
- 2017
: : : : :
:
| 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: lisaliu@apexbio.com
Phone: 011-886-3-5641952
FAX: 011-886-3-5678302 |
| Date Prepared: | March 1, 2012 |
| Trade Names: | AutoSure Voice 3 Plus Blood Glucose Monitoring System
AutoSure Plus Blood Glucose Test Strips |
| Classification: | Glucose test system, 21 CFR 862.1345, Class II |
| Product Codes: | CGA, NBW |
| Predicate Device: | AutoSure Voice II Plus Blood Glucose Monitoring System (K113098)
AutoSure Plus Blood Glucose Test Strip (K113098 ) |
| Device Description: | The AutoSure Voice 3 Plus blood glucose meter and AutoSure Plus test
strips are used for testing of blood glucose by self-testers at home.
Contrex Plus III Glucose Control Solutions are used for quality control
testing of the system. |
.
.
. . . . . . . . . .
.
1
510(k) Summary (Continued)
..
.
:
. . . . . . .
.
:
.
:
.
| Intended Use: | The AutoSure Voice 3 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. The meter includes
voice functionality to assist visually impaired users. 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 AutoSure Plus Blood Glucose Test Strips are to be used with the
AutoSure Voice 3 Plus Blood Glucose Meter to quantitatively measure
glucose in capillary whole blood taken from fingertips, palm, or forearm.
They are not indicated for the diagnosis or screening of diabetes or for
neonatal use. |
| Comparison of
Technological
Characteristics: | The AutoSure Voice 3 Plus system has been modified relative to the
predicate by relocating the 3 operating buttons from the front to the side of
the meter. The AutoSure Voice 3 Plus meter uses the same test algorithm and
test strips as the predicate meter. Both systems use Contrex Plus III control
solutions. |
| Non-Clinical
Testing: | EMC & Electrical Safety and linearity testing. Results demonstrate
substantial equivalence to the predicate system. |
| Clinical Testing | A user survey shows substantial equivalence in ease-of-use after the
relocation of the operation buttons. |
| Conclusion: | Testing demonstrated that the AutoSure Voice 3 Plus system performs in a
substantially equivalent manner to that of the predicate. We conclude that
the new system is substantially equivalent to the predicate device. |
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and the comments of the comments of
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
10903 New Hampshire Avenue Silver Spring, MD 20993
Apex Biotechnology Corporation c/o Lisa Liu No. 7, Li-Hsin Road V, Hsinchu Science Park Hsinchu, China (Taiwan) 30078
6 2012 JUL
K120649 Re:
K120649
Trade Name: AutoSure 3 Plus Blood Glucose Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Codes: NBW, CGA Dated: June 7, 2012 Received: June 8, 2012
Dear Ms. Liu:
We have reviewed your Section 510(k) premarket notification of intent to market the device
tion the We have reviewed your Section 310(ts) premium is substantially equivalent (for the referenced above and have delemined the be readly marketed predicate devices marketed in
indications for use stated in the 100 100 100 100 100 100 100 100 100 100 indications for use stated in the enclosures to regars ment date of the Medical Device interstate commerce prior to Way 20, 1970, the cities with the provisions of
Amendments, or to devices that have been receassified in accordance with the provisions of Amendments, or to devices that nave been results approval of a premarket
the Federal Food, Drug, and Cosmetic Act (Act) that do require approval of a premarket the Federal Food, Drug, and Cosment Act (rec) market the device, subject to the general
approval application (PMA). You may, therefore, market the det include approval application (PMA). Tou may, marcels, increase of the Act include controls provisions of the Act. The general connell provides, good manufacturing practice, a
requirements for annual registration, listing of devices in requirements for annual regionalism, and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III
ns affective If your device is classified (sec additional controls. Existing major regulations affecting
(PMA), it may be subject to such additional controls. Existing major regulations (PMA), it may be subject to such adultions controls. Bread Regulations (CFR), Parts 800 to 895.
your device can be found in Title 21, Code of Federal Regulations (CFR), Part your device can be found in Title 21, Code of Pederal Rogalated (1 (1) 7)
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 Please be advised that FDA's Issualite of a substitutions with other requirements
mean that FDA has made a determination administered by other Federal agencies. mean that FDA has made a decimination indivise ed by other Federal agencies.
of the Act or any Federal statutes and regulations administered by registration of the Act or any Federal statues and reginations and limited to: registration
You must comply with all the Act's requirements, including, but not limited to: registration You must comply with all the Act Stequitements, and 809); medical device
and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and go and listing (21 CFR Part 807); labeling (21 CFR 803); and good reporting (reporting of medical device-related adverse overse (OS) regulation (21 CFR Part 820).
3
· Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you attire 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 I ou may 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,
N.
K. Jain, Ph.D.
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
4
5 Indications for Use Statement
510(k) Number (if known):
Device Name: AutoSure Voice 3 Plus Blood Glucose Monitoring System
Indications for Use:
The AutoSure Voice 3 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. The meter includes voice functionality to assist visually impaired users. 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 AutoSure Plus Blood Glucose Test Strips are to be used with the AutoSure Voice 3 Plus Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm. 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)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K12 0649
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