(265 days)
Not Found
No
The document describes a standard blood glucose monitoring system and does not mention any AI or ML components.
No.
A therapeutic device is used to treat or prevent a disease, whereas this device is for monitoring glucose levels. It is a diagnostic device, not a therapeutic one.
No
The device is explicitly stated as "not indicated for the diagnosis or screening of diabetes." It is instead intended as an aid for monitoring glucose levels for people already diagnosed with diabetes.
No
The device description explicitly mentions a "blood glucose 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: "Testing is done outside the body (In Vitro diagnostic use)."
N/A
Intended Use / Indications for Use
The AutoSure HT Blood Glucose Monitoring System is intended for the quanitative 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.
The AutoSure HT Blood Glucose Test Strips are to be used with the AutoSure HT Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm.
The Contrex Plus 4 glucose control solution is used with the AutoSure HT test strips to verify that the meter and test strips are working together properly and that the test is performing correctly.
Product codes
CGA, NBW, JJX
Device Description
The AutoSure HT blood glucose meter and AutoSure HT test strips are used for testing of blood glucose. Contrex Plus 4 Glucose Control Solutions are used for quality control testing of the systems.
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, single patient use, outside the body (In Vitro diagnostic use)
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: EMC and Electrical Safety, test strip holder reliability testing, battery life verification, drop testing, disinfection performance (robustness of meter to multiple cleanings and disinfections), software verification and validation, and linearity testing with validation of Lo/Hi detection, temperature and humidity testing, sample volume verification, precision testing, interferences testing, altitude testing, qualification of control solutions, hematocrit performance testing, Disinfection testing with recommended disinfectant wipes was done using an animal virus test model. Results demonstrate substantial equivalence to the predicate system.
Clinical Testing:
An accuracy study was conducted with blood testing at finger, palm, and forearm sites by healthcare professionals. A User Performance study was conducted with self-testing at finger, palm, and forearm sites by home users, including evaluation of ease of use and ease of understanding of the user manual. Results demonstrate substantial equivalence to the predicate system.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
0
510(k) Summary
| Submitter: | Apex Biotechnology Corp.
No. 7, Li-Hsin Road V, Hsinchu Science Park
Hsinchu, 30078
CHINA (TAIWAN) |
|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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: | February 17, 2014 |
| Trade Names: | AutoSure HT Blood Glucose Monitoring System
AutoSure HT Blood Glucose Test Strips
Contrex Plus 4 Glucose Control Solutions |
| Classification: | Glucose test system, 21 CFR 862.1345, Class II
Single (specified) analyte controls (assayed and unassayed), Class I, 21
CFR 862.1660 |
| Product Codes: | CGA, NBW; JJX |
| Predicate Devices: | GAL-1A Blood Glucose Monitoring System (K113208)
Contrex Plus III Glucose Control Solutions (K113098) |
| Device Description: | The AutoSure HT blood glucose meter and AutoSure HT test strips are
used for testing of blood glucose. Contrex Plus 4 Glucose Control
Solutions are used for quality control testing of the systems. |
| Intended Use: | AutoSure HT Blood Glucose Monitoring System
The AutoSure HT 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.
AutoSure HT Blood Glucose Test Strips
The AutoSure HT Blood Glucose Test Strips are to be used with the AutoSure
HT Blood Glucose Meter to quantitatively measure glucose in capillary whole
blood taken from fingertips, palm, or forearm.
Contrex Plus 4 Glucose Control Solutions
The Contrex Plus 4 glucose control solution is used with the AutoSure HT
meter and AutoSure HT test strips to verify that the meter and test strips are
working together properly and that the test is performing correctly. |
| Comparison of
Technological
Characteristics: | The AutoSure HT meter has been modified relative to the predicate by minor
changes in external design and modifications of the test strip holder to
support the hematocrit compensation feature. Meter software has been
augmented to support the hematocrit compensation feature. The AutoSure
HT test strip has been modified relative to the predicate by minor changes in
chemistry [17% increase in glucose oxidase, 6% increase in electron shuttle],
alteration of electrode tracks to support 8 calibration codes, and addition of a
second blood channel to support the hematocrit compensation feature. The
chemistry of the Contrex Plus 4 control solutions has been modified slightly
to increase viscosity. |
| Non-Clinical
Testing: | Testing was conducted as follows: EMC and Electrical Safety, test strip
holder reliability testing, battery life verification, drop testing, disinfection
performance (robustness of meter to multiple cleanings and disinfections),
software verification and validation, and linearity testing with validation of
Lo/Hi detection, temperature and humidity testing, sample volume
verification, precision testing, interferences testing, altitude testing,
qualification of control solutions, hematocrit performance testing,
Disinfection testing with recommended disinfectant wipes was done using an
animal virus test model. Results demonstrate substantial equivalence to the
predicate system. |
| Clinical Testing | An accuracy study was conducted with blood testing at finger, palm, and
forearm sites by healthcare professionals. A User Performance study was
conducted with self-testing at finger, palm, and forearm sites by home users,
including evaluation of ease of use and ease of understanding of the user
manual. Results demonstrate substantial equivalence to the predicate system. |
| Conclusion: | Clinical and non-clinical testing demonstrated that the AutoSure HT system
performs in a substantially equivalent manner to that of the predicate. We
conclude that the AutoSure HT system is substantially equivalent to the
predicate system. |
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510(k) Summary (Continued)
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510(k) Summary (Continued)
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Image /page/3/Picture/0 description: The image contains a logo for the U.S. Department of Health & Human Services. The logo features the department's seal, which includes an emblem with a stylized caduceus-like symbol. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Centrol Center - WO66-G609
Silver Spring, MD 20993-0002 March 6, 2014
APEX BIOTECHNOLOGY CORP. HSUE-MEI LEE,MANAGER, QA NO. 7, LI-HSIN ROAD V, HSINCHU SCIENCE PARK HSINCHU 30078, CHINA (TAIWAN)
Trade/Device Name: AutoSure HT Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: CGA, NBW, JJX Dated: January 24, 2014 Received: January 28, 2014
Dear Ms. Lee:
Re: K131750
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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2-Ms. Lee
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact 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/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
CourtneyH.Lias-S
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
5
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
: . . . Indications for Use
510(k) Number (if known) K131750
ﻴﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟ
Device Name
AutoSure HT Blood Glucose Monitoring System
Indications for Use (Describe)
The AutoSure HT Blood Glucose Monitoring System is intended for the quanitative 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.
The AutoSure HT Blood Glucose Test Strips are to be used with the AutoSure HT Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm.
The Contrex Plus 4 glucose control solution is used with the AutoSure HT test strips to verify that the meter and test strips are working together properly and that the test is performing correctly.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED,
FOR FDA USE ONLY · .
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (1/14)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.