URS-IG (GLUCOSE TEST) by TECO DIAGNOSTICS

The TECO Diagnostics URS-1G (Glucose Test) is intended for "Over the Counter use." The test is used, by lay people, for a qualitative determination of glucose in human urine. Urinary glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia.

Device Description

Not Found

AI/ML Overview

This is an FDA Premarket Notification (510k) Summary for a urine glucose test. Unfortunately, the provided document does not contain the detailed study information required to answer your questions comprehensively. It primarily concerns the FDA's substantial equivalence determination for the URS-1G (Glucose Test) and its intended use.

Here's what can be extracted and what information is missing based on your request:

Acceptance Criteria and Device Performance (Partial)

The document doesn't explicitly state "acceptance criteria" or provide a table of reported device performance in the way you've requested. However, for a diagnostic device like this, common performance metrics would typically include sensitivity, specificity, accuracy, linearity, and precision against a reference method. The approval as "substantially equivalent" implies these aspects were deemed adequate compared to a predicate device.

Missing Information:

Here's a breakdown of the information requested that is not present in the provided document:

A table of acceptance criteria and the reported device performance: This information is generally found in the detailed study report within the 510(k) submission, not in the FDA's determination letter or the Indications for Use statement.
Sample sizes used for the test set and the data provenance: Not available in this document.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available in this document.
Adjudication method for the test set: Not available in this document.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: MRMC studies are more common for imaging devices or those requiring subjective human interpretation. For a qualitative, "over-the-counter" urine glucose test strip, an MRMC study is highly unlikely. The performance would typically be evaluated against a reference laboratory method rather than human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: For a simple diagnostic test strip, the "algorithm" is the chemical reaction on the strip. Its standalone performance is its inherent performance without human interpretation error impacting the chemical reaction itself. The "over-the-counter" nature implies lay user interpretation, but the core performance data would be the strip's ability to detect glucose accurately. The document does not specify performance data.
The type of ground truth used: For a urinary glucose test, the ground truth would most likely be established by a quantitative laboratory method (e.g., hexokinase method, glucose oxidase method) on fresh urine samples. The document does not explicitly state this.
The sample size for the training set: This refers to machine learning algorithms. This device is a chemical test strip, not an AI/ML-driven device, so there is no "training set" in that context.
How the ground truth for the training set was established: As above, not applicable for this type of device.

In summary, the provided FDA communication is primarily an approval letter and an "Indications for Use" statement. It does not contain the detailed technical and scientific study data that would be required to answer most of your questions. To obtain such information, one would typically need access to the full 510(k) submission, which is generally not publicly available in its entirety without a Freedom of Information Act (FOIA) request.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 2 1 2002

Ms. Olivia Chen Official FDA Correspondent Teco Diagnostics 1268 N. Lakeview Avenue Anaheim, CA 92807

Re: K020175

Trade/Device Name: URS-1G (Glucose Test) Regulation Number: 21 CFR 862.1340 Regulation Name: Urinary glucose (non-quantitative) test system Regulatory Class: Class II Product Code: JIL Dated: January 11, 2002 Received: January 17, 2002

Dear Ms. Chen:

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.

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.

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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 i 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 premarket notification" (21CFR 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.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

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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ATTACHMENT 3

INDICATIONS FOR USE STATEMENT

510 (K) Number (if known): ___________________________________________________________________________________________________________________________________________________

Device Name: _________________________________________________________________________________________________________________________________________________________________ URS-1G (Glucose Test) ________________________________________________________________________________________________________________________________________________________

Indications for Use:

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

Concurrence of CDRH, office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use

e-Counter Use

(Per 21 CFR 801.109)

62-87 (Division Sign-Off) Division of Clinical Laboratory Devices :10(k) Number_1(0000 (1)

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Regulation Number and Section

§ 862.1340 Urinary glucose (nonquantitative) test system.

(a)
Identification. A urinary glucose (nonquantitative) test system is a device intended to measure glucosuria (glucose in urine). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia.(b)
Classification. Class II.