(256 days)
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No
The document describes a standard blood glucose monitoring system using a meter and test strips, with no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is an in vitro diagnostic (IVD) device used for monitoring blood glucose levels, which aids in medical decision-making but does not directly treat or prevent a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is for the "quantitative measurement of glucose" and is an "aid to monitor the effectiveness of diabetes control," which are diagnostic purposes to assess a condition. The phrase "In Vitro diagnostic use" further clarifies its diagnostic nature.
No
The device description explicitly states that the system consists of a meter, test strips, and control solution, which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
The Intended Use section explicitly states: "Testing is done outside the body (In Vitro diagnostic use)." This is a clear indication that the device is intended for in vitro diagnostic use.
Furthermore, the Device Description section also reinforces this by stating: "The Advance Micro-draw™ 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." Testing blood samples outside the body to diagnose or monitor a condition is the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Advance Micro-draw™ Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or palm. 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.
Advance Micro-draw™ Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or palm. Advance Micro-draw™ Test Strips must be used with the Advance Microdraw™ 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.
For use with Advance Micro-draw™ Blood Glucose Meter and Advance Microdraw™ Test Strips as a quality control check to verify the accuracy of blood qlucose test results.
Product codes (comma separated list FDA assigned to the subject device)
CGA, NBW, JJX
Device Description
The Advance Micro-draw™ 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 Advance Micro-draw™ Blood Glucose Test Strips.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
fingertips or palm
Indicated Patient Age Range
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Intended User / Care Setting
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
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Description of the test set, sample size, data source, and annotation protocol
Accuracy/method correlation testing was done comparing fingertip results obtained by clinicians with alternate site results obtained by participants with diabetes.
Testing included both men and women, both Type 1 and Type 2 diabetes, ages from twenty to seventy-eight. Tested blood glucose values encompassed the 51-435 mg/dL glucose range. Linear regression statistics showed good correlation between fingertip and alternate site results.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Testing: Accuracy/method correlation testing was done comparing fingertip results obtained by clinicians with alternate site results obtained by participants with diabetes. Testing included both men and women, both Type 1 and Type 2 diabetes, ages from twenty to seventy-eight. Tested blood glucose values encompassed the 51-435 mg/dL glucose range. Linear regression statistics showed good correlation between fingertip and alternate site results.
Conclusions from Testing: Testing demonstrated that the performance of Advance Micro-draw™ at the claimed alternate site was substantially equivalent to that at fingertip.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
LifeScan OneTouch® Ultra® Blood Glucose Monitoring System
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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Ko4/881/
MAR 2 5 2005
510(k) Summary
| 1. SUBMITTED BY: | Bruce A. MacFarlane, Ph.D.
Hypoguard USA, Inc.
5182 West 76 th Street
Minneapolis, MN 55439
USA |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Summary prepared: 28 February 2005 |
| 2. NAME OF DEVICES: | |
| Trade Names: | Advance Micro-draw TM Glucose Monitoring System
Advance Micro-draw TM Test Strips
Advance Micro-draw TM High Control Solution
Advance Micro-draw TM Normal Control Solution |
| Common Names/Descriptions: | Blood glucose monitoring system |
| Classification Names: | - Glucose test system, product codes CGA & NBW,
21 CFR 862.1345
- Single (specified) analyte controls
(assayed/unassayed), product code JJX, 21
CFR 862.1660 |
| Regulatory Status: | Class II |
| PREDICATE DEVICE: | LifeScan OneTouch ® Ultra ® Blood Glucose
Monitoring System 1 |
- DEVICE DESCRIPTION:
The Advance Micro-draw™ 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 Advance Micro-draw™ Blood Glucose Test Strips.
1
1 OneTouch and Ultra are registered trademarks of LifeScan, Inc.
1
510(k) Summary (cont'd)
Hypoguard USA, Inc.
4. INTENDED USE:
The Advance Micro-draw™ Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or palm. 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.
5. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS
The Advance Micro-draw™ Blood Glucose Monitoring System is technically unchanged by this expansion of indications (claiming palm in addition to fingertip testing). The Advance Micro-draw™ trade name was "Hypoguard Advance™" at the time of initial premarket notification.
6. NON-CLINICAL TESTING
Not Applicable
7. CLINICAL TESTING
Accuracy/method correlation testing was done comparing fingertip results obtained by clinicians with alternate site results obtained by participants with diabetes.
Testing included both men and women, both Type 1 and Type 2 diabetes, ages from twenty to seventy-eight. Tested blood glucose values encompassed the 51-435 mg/dL glucose range. Linear regression statistics showed good correlation between fingertip and alternate site results.
8. CONCLUSIONS FROM TESTING
Testing demonstrated that the performance of Advance Micro-draw™ at the claimed alternate site was substantially equivalent to that at fingertip.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure in profile, with three overlapping shapes representing the head, body, and legs.
MAR 2 5 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Bruce A. MacFarlanc, Ph.D. Vice President, Regulatory Affairs and Quality Systems Hypoguard USA, Inc. 5182 West 76" Street Minneapolis, MN 55439
Re: k()41881
Trade/Device Name: Advance Micro-draw™ Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW. CGA, JJX Dated: February 28, 2005 Received: March 1, 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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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,
Jean M. Cooper MS, DUM
Jean M. Cooper, MS, D.V.M. 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): K041881
Device Name: Advance Micro-draw™ Blood Glucose Monitoring System
Indications For Use:
Advance Micro-draw™ Blood Glucose Monitoring System:
The Advance Micro-draw™ Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or palm. 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.
Advance Micro-draw™ Blood Glucose Test Strips:
Advance Micro-draw™ Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or palm. Advance Micro-draw™ Test Strips must be used with the Advance Microdraw™ 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.
Advance Micro-draw™ Control Solution:
For use with Advance Micro-draw™ Blood Glucose Meter and Advance Microdraw™ Test Strips as a quality control check to verify the accuracy of blood qlucose 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)
Carol C. Benson
37 K041881
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