(146 days)
The Assure Pro Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood. 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 Meter:
The Assure Pro Blood Glucose Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood. 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 when used with the Assure Pro Blood Glucose Meter. Testing is done outside the body (In Vitro Diagnostic Use). They are 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 Control Solution:
For use with Assure Pro Blood Glucose Meter and Assure Pro Test Strips as a quality control check to verify the accuracy of blood glucose test results.
The Assure Pro Blood Glucose Monitoring System consists of a meter, test strips, and control solution. It is intended for over-the-counter, home use by diabetics to monitor their blood glucose levels, or for use in a clinical setting by health care professionals. The system tests fresh capillary whole blood. The meter is a portable, battery-operated instrument designed for use with Assure Pro Blood Glucose Test Strips.
The provided 510(k) summary for the Assure Pro Blood Glucose Monitoring System is a premarket notification for a modification to an existing device, not a new device. Therefore, the study details are primarily focused on demonstrating that the modifications did not negatively impact the performance, rather than establishing initial performance criteria from scratch.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in a table format. However, the overarching acceptance criterion is "appropriate performance" and "substantially equivalent to that of the unmodified version."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Performance (general) | "Appropriate performance" |
| Precision | Confirmed |
| Hematocrit Range | Confirmed |
| Interferences | Confirmed |
| Minimum Sample Volume | Successful testing confirmed reduced minimum sample volume claim |
| Overall Equivalence | "Substantially equivalent to that of the unmodified version" |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the numerical sample size used for the test set. It broadly states, "Test strips were tested with fresh capillary whole blood."
- Data Provenance: Fresh capillary whole blood was used, implying prospective data collection during the testing phase. The country of origin is not specified but is presumably the USA, where the company and FDA are located.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided. For blood glucose monitoring systems, the "ground truth" is typically established by comparative measurements against a laboratory reference method, not by human experts interpreting results.
4. Adjudication Method for the Test Set
Not applicable in the typical sense for a blood glucose meter. Ground truth is established through quantitative comparison to a reference method, not through consensus of human interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC study was not done. This type of study is relevant for diagnostic imaging or interpretation tasks where multiple human readers assess cases, and AI assistance is evaluated for its impact on their performance. A blood glucose meter provides a direct quantitative measurement, not an interpretation task for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in essence, the testing performed on the device (meter and test strips) is standalone performance. The device itself generates the blood glucose reading without human interpretation of the result. The clinical and non-clinical testing assesses the accuracy and reliability of these direct measurements.
7. The Type of Ground Truth Used
The document implies that the ground truth for performance verification would be established by comparison to a recognized laboratory reference method for blood glucose measurement. While not explicitly stated, this is standard practice for blood glucose meter validation.
8. The Sample Size for the Training Set
No training set is mentioned or applicable in the AI sense. This device is a traditional electrochemical blood glucose meter, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no AI/ML training set was involved.
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MAR 2 8 2006
510(k) SUMMARY
- SUBMITTED BY:
Bruce A. MacFarlane, Ph.D. Hypoguard USA, Inc. 5182 West 76th Street Minneapolis, MN 55439 952-646-3188 (phone) 952-646-3110 (fax)
Summary prepared: 28 October 2005
- NAME OF DEVICE:
Trade Name:
Common Names/Descriptions:
Classification Names:
Assure Pro Blood Glucose Monitoring System
Blood glucose monitoring system
"Glucose test system", product code 75CGA and "System, test, blood glucose, over the counter", product code 75NBW, 21 CFR 862.1345
-
- PREDICATE DEVICE: Assure Pro Blood Glucose Monitoring System
-
- DEVICE DESCRIPTION:
The Assure Pro Blood Glucose Monitoring System consists of a meter, test strips, and control solution. It is intended for over-the-counter, home use by diabetics to monitor their blood glucose levels, or for use in a clinical setting by health care professionals. The system tests fresh capillary whole blood. The meter is a portable, battery-operated instrument designed for use with Assure Pro Blood Glucose Test Strips.
-
- INTENDED USE:
This modification does not alter the original intended use:
- INTENDED USE:
The Assure Pro Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood. 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.
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6. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS
The modified Assure Pro System has the same technological characteristics as the original system.
7. NON-CLINICAL TESTING
Successful testing was done to confirm the reduced minimum sample volume claim and to verify key performance characteristics including precision, hematocrit range, and interferences.
8. CLINICAL TESTING
Test strips were tested with fresh capillary whole blood to verify performance was not compromised by the modifications. Testing confirmed appropriate performance.
9. CONCLUSIONS FROM TESTING
Testing demonstrated that the performance of the modified Assure Pro was substantially equivalent to that of the unmodified version.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the symbol.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
VAR 2 8 2006
Bruce A. MacFarlane, Ph.D. Vice President, Regulatory Affairs and Quality Systems Hypoguard USA, Inc. 5182 West 7610 Street Minneapolis, MN 55439
Re: K053079
Trade/Device Name: Assure® Pro Blood Glucose Monitoring System Assure® Pro Blood Glucose Meter Assure® Pro Blood Glucose Test Strips Assure® Pro Control Solution Regulation Number: 21 CFR& 862.1345 Regulation Name: Glucose test system
Regulatory Class: Class II Product Code: CGA, NBW, JJX Dated: March 9, 2006 Received: March 10, 2006
Dear Dr. MacFarlane:
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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Alberto Gutierrez, Ph.D.
Alberto Gutierrez, Ph.D. 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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Indications for Use
510(k) Number (if known): K053019
Device Name: Assure® Pro 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 qlucose in fresh capillary whole blood. 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 Meter:
The Assure Pro Blood Glucose Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood. 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 when used with the Assure Pro Blood Glucose Meter. Testing is done outside the body (In Vitro Diagnostic Use). They are 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 Control Solution:
For use with Assure Pro Blood Glucose Meter and Assure Pro Test Strips as a quality control check to verify the accuracy of blood glucose test results.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use V (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
CAC
Division Sign-Off
Page 1 of 1
Office of In Vitro Diagnostic Device Evaluation and Safety
§ 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.