← Product Code [JIL](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIL) · K020175 # URS-IG (GLUCOSE TEST) (K020175) _Teco Diagnostics · JIL · Mar 21, 2002 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIL/K020175 ## Device Facts - **Applicant:** Teco Diagnostics - **Product Code:** [JIL](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIL.md) - **Decision Date:** Mar 21, 2002 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.1340 - **Device Class:** Class 2 - **Review Panel:** Clinical Chemistry ## Indications for Use 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 Story URS-1G (Glucose Test) is a qualitative urine test strip for glucose detection. Used by lay people in an over-the-counter (OTC) setting. Device consists of a reagent strip; user dips strip into human urine sample; color change indicates presence and concentration of glucose. Results are interpreted visually by the user by comparing the strip color to a provided color chart. Provides information for monitoring carbohydrate metabolism disorders. No electronic components or automated processing. ## Clinical Evidence No clinical data provided; substantial equivalence based on bench testing and comparison to legally marketed predicate devices. ## Technological Characteristics Reagent-based urine test strip for qualitative glucose detection. Visual colorimetric analysis. Standalone, non-electronic, disposable device. ## Regulatory 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. ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, topped by a stylized eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular pattern around the caduceus symbol. ## 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. {1}------------------------------------------------ Page 2 - 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 {2}------------------------------------------------ ## ATTACHMENT 3 ## INDICATIONS FOR USE STATEMENT 510 (K) Number (if known): ___________________________________________________________________________________________________________________________________________________ Device Name: _________________________________________________________________________________________________________________________________________________________________ URS-1G (Glucose Test) ________________________________________________________________________________________________________________________________________________________ Indications for Use: 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. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, office of Device Evaluation (ODE) OR 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) ા ર --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIL/K020175](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIL/K020175) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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