URITEK 151 URINE ANALYZER, MODEL TC-151

K042421 · Teco Diagnostics · KQO · May 9, 2005 · Clinical Chemistry

Device Facts

• Record ID: K042421
• Device Name: URITEK 151 URINE ANALYZER, MODEL TC-151
• Applicant: Teco Diagnostics
• Product Code: KQO · Clinical Chemistry
• Decision Date: May 9, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.2900
• Device Class: Class 1

Intended Use

The Uritek-151 Urine Analyzer is intended for use with Teco Urine Reagent Strips for Urinalysis such URS-10, used in the determination of glucose, protein, pH, bilirubin, blood, ketone, urobilinogen, nitrite, specific gravity, and leukocytes in urine.

Device Story

Uritek-151 Urine Analyzer is an automated urinalysis system for clinical use. It processes urine reagent strips (e.g., URS-10) to determine clinical values for ten analytes. The device uses a cold light source to scan reaction pads on the strip with two monochromatic light beams. Optical signals are transformed into electrical signals, which are processed by an internal controller to compute reflectance ratios. The device compares these ratios against internal standards to produce clinical results, which are displayed or printed. The system is self-calibrating using a white calibration bar upon power-up. It supports single-step or continuous testing modes. Operators manually dip the strip and place it on the test table. The device provides automated analysis to assist healthcare providers in urinalysis, reducing manual interpretation variability and improving testing reliability.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and comparison to legally marketed predicate devices.

Technological Characteristics

Automated urine analyzer; optical reflectance sensing principle; utilizes Teco Urine Reagent Strips for colorimetric analysis of urine analytes. Device is a standalone benchtop instrument.

Indications for Use

Indicated for use with Teco Urine Reagent Strips (e.g., URS-10) for the semi-quantitative or qualitative determination of glucose, protein, pH, bilirubin, blood, ketone, urobilinogen, nitrite, specific gravity, and leukocytes in urine samples.

Regulatory Classification

Identification

An automated urinalysis system is a device intended to measure certain of the physical properties and chemical constituents of urine by procedures that duplicate manual urinalysis systems. This device is used in conjunction with certain materials to measure a variety of urinary analytes.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY - 9 2005

Mr. Tong S. Chiah FDA Coorespondent Teco Diagnostics 1268 North Lakeview Avenue Anaheim, CA 92807

Re: k042421

Trade/Device Name: Uritek-151 Urine Analyzer Regulation Number: 21 CFR 862.1340 Regulation Name: Urinary glucose (non-quantitative) test system Regulatory Class: Class II Product Code: JIL, JIO LIX, JRE, CEN, JMT, JIR, JIN, CDM, JJB, KQO Dated: February 25, 2005 Received: March 2, 2005

Dear Mr. Chiah:

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 n may be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Jean M. Cooper MS, DUM

Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K042421

Device Name: Uritek-151 Urine Analyzer

Indications For Use:

The Uritek-151 Urine Analyzer is intended for use with Teco Urine Reagent Strips for Urinalysis The Offick 19 Print Thialy Lermination of glucose, protein, pH, bilirubin, blood, ketone, urobilinogen, nitrite, specific gravity, and leukocytes in urine.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

vision Sign-Off

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Office of In Vitro Diagnostic
Device Evaluation and Safety

Stork: K04242