(118 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 in clinical settings by healthcare professionals, or at home (over the counter [OTC]) by persons with diabetes, as an aid to monitor the effectiveness of diabetes control.
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 persons with diabetes 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 Test Strips.
The provided 510(k) summary for the Assure® Pro Blood Glucose Monitoring System describes a clinical study to demonstrate its accuracy. However, specific acceptance criteria and detailed performance metrics are not explicitly stated in the provided text. The summary generally claims "good correlation" without quantifying it against pre-defined thresholds.
Here's a breakdown of the requested information based on the provided text, highlighting where information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. The document mentions "good correlation" but doesn't provide numerical thresholds for accuracy (e.g., % within +/- X mg/dL, or accuracy metrics against a reference standard). | Linear regression statistics showed "good correlation between participant, clinician and reference results." Tested blood glucose values encompassed the 61-383 mg/dL glucose range. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "participants with diabetes" but does not quantify the number of individuals or the number of samples collected.
- Data Provenance: The study was a prospective clinical testing, comparing results obtained by participants with diabetes against clinician results and reference methods. The country of origin for the data is not specified, but the submission is from Hypoguard USA, Inc. in Minneapolis, MN, USA, suggesting a US-based study.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: The document refers to "clinician results" as part of the comparison. It does not specify the number of clinicians involved or their specific qualifications (e.g., "radiologist with 10 years of experience"). However, given the context of a blood glucose monitor, these would likely be healthcare professionals, potentially nurses, phlebotomists, or laboratory technicians who are trained in blood drawing and glucose measurement.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- The document describes comparing results among "participants with diabetes," "clinician results," and "reference method results." This implies a comparison against a gold standard (reference method) and potentially other professional measurements. However, it does not describe an adjudication method in the sense of resolving discrepancies between human readers or experts (e.g., 2+1, 3+1). The "reference method" itself acts as the de facto "ground truth" against which all other measurements are compared.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done in the context typically understood for AI/imaging devices (i.e., assessing human performance with vs. without AI assistance). This study focuses on the accuracy of a standalone device (blood glucose monitor) compared to reference methods and clinician measurements.
6. Standalone Performance Study
- Yes, a standalone study was done. The "Accuracy/method correlation testing" directly evaluated the performance of the Assure® Pro Blood Glucose Monitoring System itself by comparing its readings to a recognized reference method and clinician results. This is a direct measure of the algorithm/device's accuracy.
7. Type of Ground Truth Used
- The type of ground truth used was a reference method. For blood glucose monitoring systems, this typically involves a laboratory-based, highly accurate method (e.g., using a YSI glucose analyzer or a similar clinical chemistry analyzer) that is considered the gold standard for glucose measurement. The document states "reference method results."
8. Sample Size for the Training Set
- The document does not specify a training set sample size. This k-summary describes the device validation (clinical testing) to support substantial equivalence, not the development or training of an algorithm in the modern AI sense. Blood glucose meters do not typically involve "training sets" in the same way machine learning models do. Their calibration is usually established during manufacturing and validated through rigorous testing.
9. How Ground Truth for the Training Set Was Established
- As there is no mention of a "training set" in the context of an AI/machine learning model, this question is not applicable based on the provided document. The device operates based on electrochemical principles, and its internal calibration would be set during manufacturing and validated through testing, not through a "training set" in the sense of supervised learning.
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K os1514
OCT 4 - 2005
510(k) Summary
| 1. SUBMITTED BY: | Bruce A. MacFarlane, Ph.D.Hypoguard USA, Inc.5182 West 76th StreetMinneapolis, MN 55439USAPhone: 952-646-3188 |
|---|---|
| ------------------ | ----------------------------------------------------------------------------------------------------------------------------------- |
Summary prepared: 6 June 2005
2. NAME OF DEVICES:
| Trade Names: | Assure® Pro Blood Glucose Monitoring System |
|---|---|
| Assure® Pro Blood Glucose Meter | |
| Assure® Pro Test Strips | |
| Assure® Pro Level 1 Control Solution | |
| Assure® Pro Level 2 Control Solution | |
| Common Names/Descriptions: | Blood glucose monitoring system |
| Classification Names: | - Glucose test system, product codes CGA & NBW21 CFR 862.1345 |
| - Single (specified) analyte controls |
(assayed/unassayed), product code JJX, 21 CFR 862.1660
Regulatory Status: Class II
Advance Micro-draw™ Blood Glucose Monitoring PREDICATE DEVICE: 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 persons with diabetes 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 Test Strips.
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Hypoguard USA, Inc.
4. 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 in clinical settings by healthcare professionals, or at home (over the counter [OTC]) by persons with diabetes, as an aid to monitor the effectiveness of diabetes control.
5. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS
The Assure Pro Blood Glucose Monitoring System shares the same technological characteristics as the predicate except that 1) test strips are inserted in the top of the meter (instead of the bottom), 2) there is a strip-eiection mechanism, and 3) there is a backlight to the display screen.
6. NON-CLINICAL TESTING
Electromagnetic compatibility (EMC) testing was conducted.
7. CLINICAL TESTING
Accuracy/method correlation testing was done comparing results obtained by participants with diabetes against clinician results and reference method results.
Testing included both men and women, both Type 1 and Type 2 diabetes, ages from eighteen to eighty-two. Tested blood glucose values encompassed the 61-383 mg/dL glucose range. Linear regression statistics showed good correlation between participant, clinician and reference results.
8. CONCLUSIONS FROM TESTING
Testing demonstrated that the performance of Assure Pro was substantially equivalent to that of the predicate.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three wing segments, representing health, services, and people. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Public Health Service
OCT 4 - 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Bruce A. MacFarlane, Ph.D. Vice President, Regulatory Affairs and Quality Systems Hypoguard USA. Inc. 5182 West 76th Street Minneapolis, MN 55439
Re: K051514
Trade/Device Name: Assure® Pro Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA Dated: September 23, 2005 Received: September 27, 2005
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.
Carol C. Benem
Carol C. Benson, M.A. 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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Indications for Use
510(k) Number (if known): Kosl 514
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 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). 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 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) | |
|---|---|
| Division Sign-Off | Page 1 of 1 |
| Office of In Vitro Diagnostic Device | |
| Evaluation and Safety | |
| 510(k) | K051514 |
8
§ 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.