URITEK-720+ URINE ANALYZER

K051526 · Teco Diagnostics · KQO · Aug 16, 2005 · Clinical Chemistry

Device Facts

• Record ID: K051526
• Device Name: URITEK-720+ URINE ANALYZER
• Applicant: Teco Diagnostics
• Product Code: KQO · Clinical Chemistry
• Decision Date: Aug 16, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.2900
• Device Class: Class 1

Intended Use

The Uritek-720+ Urine Analyzer is intended for use with Teco Urine Reagent Strips for Urinalysis such as URS-10, used in the determination of glucose, protein, pH, bilirubin, blood, ketone, urobilinogen, nitrite, specific gravity, and leukocytes in urine.

Device Story

Uritek-720+ Urine Analyzer is an automated urinalysis system; processes urine reagent strips (e.g., URS-10). Input: colorimetric changes on reagent strips; captured via Contact Image Sensor (CIS). Operation: user dips strip, places on test table; device scans reflectance of red, green, blue light; computes reflectance ratio using internal algorithm. Output: semi-quantitative/qualitative results for 10 analytes. Used in clinical settings; operated by healthcare personnel. Benefits: standardized, automated interpretation of urine chemistry compared to visual reading; reduces subjectivity; improves consistency in clinical decision-making regarding patient metabolic or renal status.

Clinical Evidence

No clinical data. Bench testing only. Precision/reproducibility evaluated using 20 replicates of three control levels across two instruments and two lots, showing high agreement (95-100%). Method comparison performed on 100 specimens using Teco strips on Uritek-720+ versus Bayer Multistix 10SC on Clinitek-200+, confirming substantial equivalence.

Technological Characteristics

Automated urinalysis system using reflectance photometry. Sensing: Contact Image Sensor (CIS). Energy: Electrical. Form factor: Benchtop (260 x 320 x 178 mm; 2.4 kg). Connectivity: Manual or barcode patient ID entry. Calibration: Self-calibrating on power-up using internal white reference. Software: Embedded system for signal processing and reflectance ratio computation.

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

AUG 1 6 2005

Ms. Stephanie Low FDA Correspondent Teco Diagnostics 1268 N. Lakeview Ave Anaheim, CA 92807

Re: k051526

> Trade/Device Name: Uritek-720+Urine Analyzer Regulation Number: 21 CFR 862.1340 Regulation Name: Urinary glucose (non-quantitative) test system Regulatory Class: Class II Product Code: JIL, JIO, LJX, JRE, CEN, JMT, JIR, JIN, CDM, JJB, KQO Dated: April 26, 2005 Received: June 8, 2005

Dear Ms. Low:

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, Trug, 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, l'isting 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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal De-gister.

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 manufagturing 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,

Carol C. Benam

Carol C. Benson, M.A. Acting 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): k051526.

Device Name: Uritek-720+ Urine Analyzer

Indications For Use:

The Uritek-720+ Urine Analyzer is intended for use with Teco Urine Reagent Strips for Urinalysis such as URS-10, used in the determination of glucose, protein, pH, bilirubin, blood, ketone, urobilinogen, nitrite, specific gravity, and leukocytes in urine.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

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