(241 days)
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Not Found
No
The description focuses on standard blood glucose monitoring technology and voice functionality for accessibility, with no mention of AI or ML.
No
This device is for monitoring blood glucose levels, which aids in managing diabetes, but it does not directly treat or cure the condition.
No.
The device is specifically stated as "not indicated for the diagnosis or screening of diabetes". Instead, it serves as an aid to monitoring glucose levels for people already diagnosed with diabetes.
No
The device description explicitly states the system consists of a meter and test strips, which are hardware components.
Yes, the AutoSure Voice 3 Blood Glucose Monitoring System is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "Testing is done outside the body (In Vitro diagnostic use)."
- Definition of IVD: An IVD is a medical device used to examine specimens taken from the body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening. This device measures glucose in blood samples.
- Purpose: The system is intended for the quantitative measurement of glucose in blood samples to aid in monitoring levels in Diabetes Mellitus, which is a diagnostic purpose.
Therefore, based on the provided information, the AutoSure Voice 3 Blood Glucose Monitoring System clearly falls under the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
System: The AutoSure Voice 3 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. 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. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.
Test Strip: The AutoSure Blood Glucose Test Strips are to be used with the AutoSure Voice II and AutoSure Voice 3 Blood Glucose Meters to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm. The AutoSure Voice II and AutoSure Voice 3 Blood Glucose Monitoring Systems are plasma-calibrated for easy comparison to lab results. They are intended for self-testing by persons with diabetes and should be used by a single patient. They are not indicated for the diagnosis or screening of diabetes or for neonatal use.
Product codes (comma separated list FDA assigned to the subject device)
CGA, NBW
Device Description
The AutoSure Voice 3 blood glucose monitoring system consists of the AutoSure Voice 3 meter and AutoSure Test Strips. It is used for testing of blood glucose by self-testers at home.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
fingertips, forearm, or palm
Indicated Patient Age Range
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Intended User / Care Setting
lay use by people with diabetes; self-testing by persons with diabetes at home.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing: Testing was conducted as follows: Software verification and validation, software integration, linearity, strip holder reliability, test strip noninterchangeability, and EMC & Electrical Safety. Results demonstrate substantial equivalence to the predicate device.
Clinical Testing: An accuracy study was performed with blood testing by healthcare professionals. Results demonstrate substantial equivalence to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
AutoSure Voice II meter and AutoSure test strips
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.
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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
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: | April 18, 2011 |
| Trade Names: | AutoSure Voice 3 Blood Glucose Monitoring System,
AutoSure Blood Glucose Test Strips |
| Classification: | Glucose test system, 21 CFR 862.1345, Class II |
| Product Codes: | CGA, NBW |
| Predicate Devices: | AutoSure Voice II meter and AutoSure test strips |
| Device Description: | The AutoSure Voice 3 blood glucose monitoring system consists of the
AutoSure Voice 3 meter and AutoSure Test Strips. It is used for testing
of blood glucose by self-testers at home. |
·
'
1
510(k) Summary (Continued)
--
| Intended Use: | System: The AutoSure Voice 3 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. 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. It is not indicated for the diagnosis
or screening of diabetes or for neonatal use.
Test Strip: The AutoSure Blood Glucose Test Strips are to be used with the
AutoSure Voice II and AutoSure Voice 3 Blood Glucose Meters to
quantitatively measure glucose in capillary whole blood taken from
fingertips, palm, or forearm. The AutoSure Voice II and AutoSure Voice 3
Blood Glucose Monitoring Systems are plasma-calibrated for easy
comparison to lab results. They are intended for self-testing by persons with
diabetes and should be used by a single patient. They are not indicated for
the diagnosis or screening of diabetes or for neonatal use. |
|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison of
Technological
Characteristics: | The AutoSure Voice 3 meter uses the same test algorithm, test strip, and
control solutions as the predicate. Meter dimensions and button locations
were modified relative to the predicate. |
| Non-Clinical
Testing: | Testing was conducted as follows: Software verification and validation,
software integration, linearity, strip holder reliability, test strip
noninterchangeability, and EMC & Electrical Safety. Results demonstrate
substantial equivalence to the predicate device. |
| Clinical Testing | An accuracy study was performed with blood testing by healthcare
professionals. Results demonstrate substantial equivalence to the predicate
device. |
| Conclusion: | Clinical and non-clinical testing demonstrated that the AutoSure Voice 3
meter with the AutoSure Test Strip perform in a substantially equivalent
manner to that of the predicate device. We conclude that the AutoSure Voice
3 system is substantially equivalent to the predicate device. |
:
·
.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with flowing lines, representing the department's mission of health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol, emphasizing the department's name and national scope.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
APR 28 2011
Apex Biotechnology Corp. c/o Ms. Lisa Liu No. 7, Li-Hsin Road V Hsinchu Science Park Hsinchu, China (Taiwan) 30078
Re: K102481
Trade Name: AutoSure Voice 3 Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: CGA, NBW, JJX Dated: April 18, 2011 Received: April 20, 2011
Dear Ms. 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. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
3
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation (21 CFR Parts 801 and 5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
C.C.
Courthey Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): K102481
Device Name: AutoSure Voice 3 Blood Glucose Monitoring System Indications for Use:
AutoSure Voice 3 Blood Glucose Monitoring System:
The AutoSure Voice 3 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearn, or palm. Testing is done outside the body (In Vitro diagnostic use). 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. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.
AutoSure Blood Glucose Test Strips:
The AutoSure Blood Glucose Test Strips are to be used with the AutoSure Voice II and AutoSure Voice 3 Blood Glucose Meters to quantitatively measure glucose in capillary whole Hood taken from fingertips, palm, or forearm. The AutoSure Voice II and AutoSure Voice 3 Blood Glucose Monitoring Systems are plasma-calibrated for easy comparison to lab results. They are intended for self-testing by persons with diabetes and should only be used by a single patient. They are not indicated for the diagnosis or screening of diabetes or for neonatal use.
Prescription Use J Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ 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 of
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) R/024