(185 days)
Not Found
No
The summary describes a standard blood glucose monitoring system and explicitly states "Not Found" for mentions of AI, DNN, or ML, and descriptions of training/test sets.
No
The device is an in vitro diagnostic device used to measure glucose levels, which aids in monitoring diabetes control but does not directly treat or prevent the disease.
Yes
The device is described as an "aid to monitor the effectiveness of diabetes control," which implies a diagnostic function in monitoring a condition. Also, it states "Testing is done outside the body (In Vitro diagnostic use)," directly labeling it for diagnostic use, even though it clarifies it's not for the initial diagnosis or screening of diabetes.
No
The device description explicitly states that the system consists of a meter, test strips, and control solutions, 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)."
This statement directly confirms that the Assure Pro Blood Glucose Monitoring System is intended for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
The Assure Pro Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. The Assure Pro Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
Product codes
CGA, NBW, JJX
Device Description
The Assure Pro Blood Glucose Monitoring System consists of a meter, test strips, and two levels of control solutions for use as an aid to monitor the effectiveness of diabetes control.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertips
Indicated Patient Age Range
Not intended for use on neonates.
Intended User / Care Setting
at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
A full array of in-house and clinical testing was done consistent with relevant FDA guidance's for blood glucose monitoring systems. Bench testing included evaluation of interferences, linearity, linear range, altitude effects, control solution functionality, and analytical precision. Clinical testing included evaluation of accuracy for the finger stick.
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
7 510(k) Summary
AUG 1 4 2009
| Submitter: | ARKRAY Factory USA, Inc.
5182 W. 76th Street
Minneapolis, MN 55439 |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Hamid Idrissi
Regulatory Affairs Project Manager
ARKRAY Factory USA, Inc.
5182 W. 76th Street
Minneapolis, MN 55439
Phone: 952-646-3171
Fax: 952-646-3110
idrissih@ARKRAYusa.com. |
| Date Prepared: | February 6, 2009 |
| Trade Name: | Assure Pro Meter Test Strips |
| Classification: | Glucose test system, 21 CFR 862.1345 and 862.1660; Class II |
| Product Codes: | CGA, NBW, JJX |
| Predicate Device: | Assure Pro Meter (K053079) |
| Device Description: | The Assure Pro Blood Glucose Monitoring System consists of a meter,
test strips, and two levels of control solutions for use as an aid to
monitor the effectiveness of diabetes control. |
| Intended Use: | The Assure Pro Blood Glucose Monitoring System is intended for the
quantitative measurement of glucose in fresh capillary whole blood
samples drawn from the fingertips. Testing is done outside the body
( In Vitro diagnostic use). It is indicated for use at home (over the
counter [OTC]) by persons with diabetes, or in clinical settings by
healthcare professionals, as an aid to monitor the effectiveness of
diabetes control. |
| Functional and
Safety Testing: | A full array of in-house and clinical testing was done consistent with
relevant FDA guidance's for blood glucose monitoring systems.
Bench testing included evaluation of interferences, linearity, linear
range, altitude effects, control solution functionality, and analytical
precision.
Clinical testing included evaluation of accuracy for the finger stick. |
| Conclusion: | Labeling, bench testing results and clinical testing results support the
Indications for Use and the claim of substantial equivalence to the
predicate. |
・・
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Arkray Factory USA. Inc. c/o Mr. Hamid Idrissi Regulatory Affairs Project Manager 5182 West 76th Street Minneapolis, MN 55439
AUG 1 4 2009
K090332 Re:
Trade Name: Assure Pro Blood Glucose Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Codes: NBW. CGA. JJX Dated: July 31, 2009 Received: August 4, 2009
Dear Mr. Idrissi:
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 (OS) regulation (21 CFR Part 820).
2
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,
G.C.H.
Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
3
6- Indications for Use Statement
510(k) Number (if known):
Device Name: Assure Pro Meter Blood Glucose Monitoring System
Indications For Use:
Assure Pro Blood Glucose Monitoring System:
The Assure Pro Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. The Assure Pro Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
Assure Pro Blood Glucose Meter:
The Assure Pro Blood Glucose Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
Assure Pro Blood Glucose Test Strips:
Assure Pro test strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips when used with the Assure Pro Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). They are indicated for use in home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
Assure Dose CONTROL:
For use with Assure Pro Blood Glucose Meter and Assure Pro Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results. Control solutions are available in two levels - Level 1 (Normal) and Level 2 (High).
Over-The-Counter Use Prescription 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)
rrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) vision Sign-Off
Office of in Vitro Diagnostic Device Evaluation and Sat