(29 days)
The Hypoguard ADVANCE™ 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 a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
The Hypoguard ADVANCE™ Blood Glucose Meter is intended for use with Hypoguard ADVANCE™ Blood Glucose Test Strips 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 a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
The Hypoguard ADVANCE™ Blood Glucose Test Strips are intended for use with Hypoguard ADVANCE™ Blood Glucose Meter 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 a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
Hypoguard ADVANCE™ Control Solution is intended for use with the Hypoguard ADVANCE™ Meter and Hypoguard ADVANCE™ Test Strips as a quality control check to verify the accuracy of blood glucose test results.
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The provided text is a U.S. FDA 510(k) clearance letter for the Hypoguard ADVANCE™ Blood Glucose Monitoring System. This document does not contain the detailed study information required to answer your prompt thoroughly.
Specifically, the letter states that the device is "substantially equivalent" to legally marketed predicate devices, which implies that its performance is comparable to existing glucose monitoring systems. However, it does not provide the acceptance criteria, the results of specific studies, sample sizes, expert qualifications, or ground truth methods related to the device's performance.
The letter confirms the "Indications For Use" for the Hypoguard ADVANCE™ system, meter, test strips, and control solution, which is that it's for quantitative measurement of glucose in fresh capillary whole blood for in vitro diagnostic use, both at home and in clinical settings, as an aid to monitor diabetes control.
To answer your specific questions, information about performance criteria and study details would typically be found in the 510(k) submission summary or in a separate study report, which is not part of this clearance letter.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance: Not present.
- Sample size used for the test set and the data provenance: Not present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
- Adjudication method: Not present.
- Multi Reader Multi Case (MRMC) comparative effectiveness study, including effect size: Not present. Glucose meters are generally standalone, so an MRMC study with human readers would be exceptionally rare for this type of device.
- Standalone (algorithm only) performance study: While the device is a standalone system, the details of its standalone performance study (e.g., accuracy metrics vs. a reference method) are not provided here.
- Type of ground truth used: Not present, but for blood glucose meters, the ground truth is typically a laboratory reference method (e.g., YSI analyzer).
- Sample size for the training set: Not applicable/not present. For a device like a blood glucose meter, the "training set" in an AI/algorithm sense is less relevant than the design, calibration, and validation against a reference method.
- How the ground truth for the training set was established: Not applicable/not present.
In summary, the provided document is an FDA clearance letter and does not contain the detailed study results needed to answer your questions.
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Image /page/0/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 representing a human figure, composed of three curved lines that suggest a profile view of a person's head and shoulders.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 2 9 2002
Hypoguard USA, Inc. c/o Mr. Mark Job Responsible Third Party Official 510(k) Program Manager TUV Product Service 1775 Old Highway 8 NW, Suite 104 New Brighton, MN 55112-1891
Re: K020232
Trade/Device Name: Hypoguard ADVANCE™ Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW; CGA Dated: January 11, 2002 Received: January 14, 2002
Dear Mr. Job:
This SE Letter corrects SE Letter stamp dated February 12, 2002. The previous letter was not sent to the Third Party, Mr. Mark Job, but to Dr. Bruce MacFarlane. This letter also corrects the Received Date from January 14, 2001 to January 14, 2002. This letter now corrects both errors.
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594- . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications For Use
510(k) Number (if known):
Hvpoquard ADVANCE™ Blood Glucose Monitoring System Device Name:
Indications For Use:
Hypoquard ADVANCE™ Blood Glucose Monitoring System:
The Hypoguard ADVANCE™ 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 a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
Hypoquard ADVANCE™ Blood Glucose Meter:
The Hypoquard ADVANCE™ Blood Glucose Meter is intended for use with Hypoguard ADVANCE™ Blood Glucose Test Strips 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 a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
Hypoquard ADVANCE™ Blood Glucose Test Strips:
The Hypoquard ADVANCE™ Blood Glucose Test Strips are intended for use with Hypoguard ADVANCE™ Blood Glucose Meter 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 a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
Hypoguard ADVANCE™ Control Solution:
Hypoguard ADVANCE™ Control Solution is intended for use with the Hypoquard ADVANCE™ Meter and Hypoguard ADVANCE™ Test Strips as a quality control check to verify the accuracy of blood glucose test results.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dean Cooper
ision Sign-O Division of Clinical Laborato 510(k) Number J
(Optional Format 3-10-98)
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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.