(25 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. The performance studies are standard for this type of device and do not indicate the use of AI/ML algorithms.
No
The device is an In Vitro Diagnostic (IVD) intended for measuring glucose levels, which aids in monitoring diabetes but does not directly treat or prevent a disease.
No
The device is explicitly stated as "not indicated for the diagnosis or screening of diabetes". Instead, it serves as an aid for monitoring glucose levels for individuals already diagnosed.
No
The device description explicitly states that the system consists of a "meter and AutoSure test strips," indicating the presence of hardware components beyond just software.
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 is the defining characteristic of an IVD.
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. Testing is done outside the body (In Vitro diagnostic use). The meter includes voice functionality to assist visually impaired users. It is indicated for both lay use by people with diabetes and in a clinical setting by healthcare professionals, as an aid to monitoring levels in Diabetes Mellitus. 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 Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm. The AutoSure Voice II Blood Glucose Monitoring System is plasma-calibrated for easy comparison to lab results. It is intended for self-testing by persons with diabetes and by health care professionals. It is 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 II blood glucose monitoring system consists of a meter and AutoSure test strips. It is used for testing of blood glucose by self-testers at home and for professional testers in healthcare facilities.
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
self-testers at home, professional testers in healthcare facilities, lay use by people with diabetes, 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
Not Found
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, Lo/Hi detection, strip holder reliability, drop testing, EMC and Electrical Safety, autocode manufacturing qualification, and verification of strip noninterchangeability between new and predicate devices. Results demonstrate substantial equivalence to the predicate device.
Clinical Testing: An accuracy study was performed with blood testing by healthcare professionals. A user study was conducted to evaluate ease-of-use of the system and ease-of-understanding of the User's Manual. 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 meter and 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.
Not Found
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
K102037 AUG 1 3 2010
・
6 510(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: | July 2, 2010 |
| Trade Names: | AutoSure Voice II 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 meter and test strips |
| Device Description: | The AutoSure Voice II blood glucose monitoring system consists of a
meter and AutoSure test strips. It is used for testing of blood glucose by
self-testers at home and for professional testers in healthcare facilities. |
| Intended Use: | System: The AutoSure Voice II Blood Glucose Monitoring System
intended for the quantitative measurement of glucose in fresh capillary wh
blood samples drawn from the fingertips, forearm, or palm. Testing is do
outside the body (In Vitro diagnostic use). The meter includes vo
functionality to assist visually impaired users. It is indicated for both lay
by people with diabetes and in a clinical setting by healthcare professiona
as an aid to monitoring levels in Diabetes Mellitus. It is not indicated for
diagnosis or screening of diabetes or for neonatal use.
Test Strip: The AutoSure Blood Glucose Test Strips are to be used with
AutoSure Voice II Blood Glucose Meter to quantitatively measure glucose
capillary whole blood taken from fingertips, palm, or forearm. The AutoS
Voice II Blood Glucose Monitoring System is plasma-calibrated for ea
comparison to lab results. It is intended for self-testing by persons w
diabetes and by health care professionals. It is not indicated for the diagno
or screening of diabetes or for neonatal use. |
| Comparison of
Technological
Characteristics: | The AutoSure Voice II meter uses the same test algorithm as the predica
The meter has been modified by relocating the 3 operating buttons. Me
software has been changed to accommodate the new autocoding feature. T
test strip and test strip holder have been modified to allow automa
detection of the calibration code upon insertion of the test strip. The t
strip is otherwise unchanged from the predicate test strip. |
| Non-Clinical
Testing: | Testing was conducted as follows: Software verification and validatic
software integration, linearity, Lo/Hi detection, strip holder reliability, dr
testing, EMC and Electrical Safety, autocode manufacturing qualificatio
and verification of strip noninterchangeability between new and predica
devices. Results demonstrate substantial equivalence to the predicate devic |
| Clinical Testing | An accuracy study was performed with blood testing by healthca
professionals. A user study was conducted to evaluate ease-of-use of t
system and ease-of-understanding of the User's Manual. Resu
demonstrate substantial equivalence to the predicate device. |
| Conclusion: | Clinical and non-clinical testing demonstrated that the AutoSure Voice
meter and AutoSure test strips perform in a substantially equivalent manr
to that of the predicate device. We conclude that the AutoSure Voice
meter and AutoSure test strips are substantially equivalent to the predica
device |
ﻨﺰ
1
510(k) Summary (Continued)
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/12 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
Public Health Service
Apex BioTechnology Corp. c/o Hsue-mei Lee Manager of Quality Assurance Department No. 7, Li-Hsin Road V, Hsinchu Science Park Hsinchu, 30078 China (Taiwan)
Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
AUG 13 2000
K102037 Re:
Trade Name: AutoSure Voice II Blood Glucose Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Codes: CGA, NBW Dated: July 2, 2010 Received: July 19, 2010
Dear Mr. 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.
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).
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Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the 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/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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Signature
Courtney C. 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
AUG 1 3 2010
Indications for Use Statement 5
510(k) Number (if known): 16 102203
Device Name: AutoSure Voice II Blood Glucose Monitoring System
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. Testing is done outside the body (In Vitro diagnostic use). The meter includes voice functionality to assist visually impaired users. It is indicated for both lay use by people with diabetes and in a clinical setting by healthcare professionals, as an aid to monitoring levels in Diabetes Mellitus. 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 Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm. The AutoSure Voice II Blood Glucose Monitoring System is plasma-calibrated for easy comparison to lab results. It is intended for selftesting by persons with diabetes and by health care professionals. It is 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 (01VD)
Signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K102037
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