The DUETTM Glucose Control Monitoring System is intended for the quantitative, colorimetric determination of glucose and fructosamine in whole blood specimens. The DUET Fructosamine Test System is intended for use by people with diabetes to monitor their blood glucose and fructosamine levels in a home use setting. This in vitro test kit is intended for home use (over the counter).

Device Description

Not Found

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific criteria for the "DUET™ Glucose Control Monitoring System." The document is a 510(k) clearance letter from the FDA, indicating that the device has been found substantially equivalent to a legally marketed predicate device.

It includes:

Device Name: DUET™ Glucose Control Monitoring System
Intended Use/Indications for Use: For the quantitative, colorimetric determination of glucose and fructosamine in whole blood specimens, intended for use by people with diabetes to monitor their blood glucose and fructosamine levels in a home use setting (over-the-counter).

However, it does not provide the following information requested in your prompt:

A table of acceptance criteria and the reported device performance: This document does not detail specific performance metrics or acceptance criteria for the DUET system.
Sample size used for the test set and the data provenance: No information about a test set, its size, or its origin is present.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no test set details are provided.
Adjudication method for the test set: Not applicable.
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: Not applicable, as this device is a glucose control monitoring system, not an AI-assisted diagnostic imaging device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: Not specified, as no study details are provided.
The sample size for the training set: Not applicable, as no algorithm training details are provided.
How the ground truth for the training set was established: Not applicable.

To obtain the information you're looking for, you would typically need to refer to the full 510(k) submission, including the performance data summarized in the submission, which is not part of this FDA clearance letter.

Summary

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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 features a stylized eagle with three heads facing to the right. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter of the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 31 1997

Vivianne T. Noetzel . Vice President, Quality Assurance and Regulatory Affairs LXN Corporation 5830 Oberlin Drive, Suite 102 San Diego, California 92121

Re: K973140 DUET™ Glucose Control Monitoring System Requlatory Class: II Product Code: CGA, LCP Dated: August 17, 1997 Received: August 21, 1997

Dear Ms. Noetzel:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. ਕੇ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. 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 Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Gutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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X. Intended Use Statement

510(k) Number (if known): K962597 Device Name: DUET Glucose Control Monitoring System

Indications For Use:

Indications for Use

The DUETTM Glucose Control Monitoring System is intended for the quantitative, colorimetric determination of glucose and fructosamine in whole blood specimens.

Intended Use

ייר - שירות מעולם - בינוע - בינק

The DUET Fructosamine Test System is intended for use by people with diabetes to monitor their blood glucose and fructosamine levels in a home use setting. This in vitro test kit is intended for home use (over the counter).

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

	Concurrence of the CDRH, Office of the Device Evaluation
Prescription UseUse	OR	Over-The-Counter	✓
(Per 21 CFR 801.109)	(Division Sign-Off)Division or Clinical Laborato510(k) Number	(Optional Format 1-2-96)	24

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Regulation Number and Section

§ 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.