URS-IG (GLUCOSE TEST)

K020175 · Teco Diagnostics · JIL · Mar 21, 2002 · Clinical Chemistry

Device Facts

• Record ID: K020175
• Device Name: URS-IG (GLUCOSE TEST)
• Applicant: Teco Diagnostics
• Product Code: JIL · Clinical Chemistry
• Decision Date: Mar 21, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1340
• Device Class: Class 2

Intended 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.

Indications for Use

Indicated for lay people for qualitative determination of glucose in human urine to aid in diagnosis and treatment of carbohydrate metabolism disorders, including diabetes mellitus, hypoglycemia, and hyperglycemia.

Regulatory Classification

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)

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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:

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)

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