CLINISTRIP

K970250 · Teco Diagnostics · JIL · Apr 8, 1997 · Clinical Chemistry

Device Facts

• Record ID: K970250
• Device Name: CLINISTRIP
• Applicant: Teco Diagnostics
• Product Code: JIL · Clinical Chemistry
• Decision Date: Apr 8, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1340
• Device Class: Class 2

Intended Use

Clinstrip 10 SGL are intended to provide semi-quantitative determination of glucose, bilirubin, ketone, specific gravity, blood, pH, protein, urobilinogen, nitrite, & leukocytes in urine. Test results may provide information regarding the status of carbohydrate metabolism, kidney & liver function, acid-base balance, & bacteriuria.

Device Story

Clinstrip 10 SGL is a multi-parameter urine test strip; used for semi-quantitative analysis of urine samples. Device consists of reagent-impregnated pads on a plastic strip. User dips strip into urine sample; color changes on pads indicate presence/concentration of analytes (glucose, bilirubin, ketone, specific gravity, blood, pH, protein, urobilinogen, nitrite, leukocytes). Results interpreted visually by comparing pad colors to a reference chart. Used in clinical settings by healthcare professionals to assess metabolic, renal, and hepatic status. Provides rapid diagnostic information to aid clinical decision-making regarding patient health status.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Multi-parameter reagent strip for urine analysis. Employs chemical colorimetric reaction principle. Visual readout via color comparison chart. Standalone, non-electronic device.

Indications for Use

Indicated for semi-quantitative urine analysis of glucose, bilirubin, ketone, specific gravity, blood, pH, protein, urobilinogen, nitrite, and leukocytes to assess carbohydrate metabolism, kidney/liver function, acid-base balance, and bacteriuria in patients.

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
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993

TECO Diagnostics
c/o Andrew Reams
4925 E. Hunter Avenue
Anaheim, CA 92807

Re: k970250
Trade Name: CLINISTRIP
Regulation Number: 21 CFR 862.1340
Regulation Name: Urinary glucose (nonquantitative) test system
Regulatory Class: Class II
Product Codes: JIL, LJX, CDM, CEN, JIN, JIR, JJB, JMT, JRE, JIO
Dated: January 17, 1997
Received: January 22, 1997

Dear Mr. Reams:

This letter corrects our substantially equivalent letter of April 8, 1997.

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 (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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Devices and Radiological Health at [phone]. Also, please note the regulation entitled, “Misbranding by reference to premarket notification” (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH’S Office of Surveillance and Biometric’s (OSB’s) Division of Postmarket Surveillance at (301) 796-576-. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH’s Office of Surveillance and Biometrics/Division of Postmarket Surveillance...

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800 638-2041 or [phone] or at its Internet address http://www.fda/gov/MedicalDevices/ResourcesforYou/Industry/default.htm

Sincerely yours,

Courtney H. Lias, Ph.D
Director
Division of Chemistry and Toxicology
Office of In Vitro Diagnostics and Radiological Health
Center for Devices and Radiological Health

Enclosure

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05/01/96 14:38 301 594 5941 CDRH ODE 002

Page ___ of ___

510(k) Number (if known): ___

Device Name: Clinstrip 10 SGL

Indications For Use:

Clinstrip 10 SGL are intended to provide semi-quantitative determination of glucose, bilirubin, ketone, specific gravity, blood, pH, protein, urobilinogen, nitrite, & leukocytes in urine. Test results may provide information regarding the status of carbohydrate metabolism, kidney & liver function, acid-base balance, & bacteriuria.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number: K910250

OR Over-The-Counter Use ___

(Optional Format 1-2-96)

Prescription Use ☑ (Per 21 CFR 801.109)

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