(185 days)
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.
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.
This document describes the Assure Pro Meter Test Strips and its associated system, cleared under K090332.
1. A table of acceptance criteria and the reported device performance
The provided document does not explicitly state numerical acceptance criteria in a table format for the Assure Pro Meter Test Strips. It broadly mentions "Functional and Safety Testing" and "Clinical testing included evaluation of accuracy for the finger stick". Without clear, quantifiable acceptance criteria from the 510(k) summary, specific reported performance against these criteria cannot be detailed.
However, the "Conclusion" states: "Labeling, bench testing results and clinical testing results support the Indications for Use and the claim of substantial equivalence to the predicate." This implies that the device's performance, as evaluated through these tests, was deemed acceptable by the FDA for its intended use.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "clinical testing included evaluation of accuracy for the finger stick" but does not specify the sample size used for this clinical test set.
The data provenance (country of origin, retrospective/prospective) is also not explicitly stated in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. For blood glucose monitoring systems, ground truth is typically established by laboratory reference methods, not by human expert interpretation of images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. Adjudication methods are typically relevant for studies involving human interpretation, not direct quantitative measurements like blood glucose.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC study was mentioned. This type of study is not applicable as the device is a blood glucose monitoring system, not an AI-powered diagnostic imaging tool requiring human reader interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The device is a standalone system – a blood glucose meter with test strips. Its performance ("accuracy for the finger stick") would inherently be evaluated without human interpretation of the measurement itself. The human-in-the-loop is the user performing the test and reading the numerical result.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the specific type of ground truth used, but for blood glucose monitoring systems, the ground truth is typically established by laboratory reference methods for glucose measurement (e.g., from a central lab or a highly accurate analyzer) against which the device's readings are compared.
8. The sample size for the training set
The device is a traditional medical device (blood glucose meter and test strips), not an AI/machine learning algorithm that requires a "training set" in the computational sense. Therefore, this concept does not apply, and no training set size is mentioned.
9. How the ground truth for the training set was established
As the device is not an AI/machine learning algorithm with a training set, this question is not applicable.
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7 510(k) Summary
AUG 1 4 2009
| Submitter: | ARKRAY Factory USA, Inc.5182 W. 76th StreetMinneapolis, MN 55439 |
|---|---|
| Contact Person: | Hamid IdrissiRegulatory Affairs Project ManagerARKRAY Factory USA, Inc.5182 W. 76th StreetMinneapolis, MN 55439Phone: 952-646-3171Fax: 952-646-3110idrissih@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 tomonitor the effectiveness of diabetes control. |
| Intended Use: | The Assure Pro Blood Glucose Monitoring System is intended for thequantitative measurement of glucose in fresh capillary whole bloodsamples drawn from the fingertips. Testing is done outside the body( In Vitro diagnostic use). It is indicated for use at home (over thecounter [OTC]) by persons with diabetes, or in clinical settings byhealthcare professionals, as an aid to monitor the effectiveness ofdiabetes control. |
| Functional andSafety Testing: | A full array of in-house and clinical testing was done consistent withrelevant FDA guidance's for blood glucose monitoring systems.Bench testing included evaluation of interferences, linearity, linearrange, altitude effects, control solution functionality, and analyticalprecision.Clinical testing included evaluation of accuracy for the finger stick. |
| Conclusion: | Labeling, bench testing results and clinical testing results support theIndications for Use and the claim of substantial equivalence to thepredicate. |
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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).
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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
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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
§ 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.