HEALTH CHECK URI-TEST PROTEIN IN URINE

K972960 · Tcpi, Inc. · JIR · Oct 7, 1998 · Clinical Chemistry

Device Facts

• Record ID: K972960
• Device Name: HEALTH CHECK URI-TEST PROTEIN IN URINE
• Applicant: Tcpi, Inc.
• Product Code: JIR · Clinical Chemistry
• Decision Date: Oct 7, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1645
• Device Class: Class 1

Intended Use

UriTest- Protein in Urine is a non-quantitative screening test to identify protein in urine. Protein in urine can be associated with renal, kidney or bladder disease.

Device Story

Uri-Test is a non-quantitative screening test for protein in urine. Device functions as a diagnostic aid to identify presence of protein, which may indicate renal, kidney, or bladder disease. Used in clinical or home settings; provides qualitative results to assist healthcare providers or patients in monitoring health status. Output is visual color change on test strip; informs clinical decision-making regarding further diagnostic testing or monitoring.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic test strip for qualitative protein detection in urine. Chemical reagent-based sensing principle. Standalone device.

Indications for Use

Indicated for non-quantitative screening of protein in urine to assist in identifying potential renal, kidney, or bladder disease in patients.

Regulatory Classification

Identification

A urinary protein or albumin (nonquantitative) test system is a device intended to identify proteins or albumin in urine. Identification of urinary protein or albumin (nonquantitative) is used in the diagnosis and treatment of disease conditions such as renal or heart diseases or thyroid disorders, which are characterized by proteinuria or albuminuria.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 7 1998

Fran White · Regulatory Consultant MDC Associates 15 Oak Street Beverly Farms, Massachusetts 01915

Re : K972960 Uri-Test Protein in Urine Regulatory Class: I Product Code: JIR Dated: August 12, 1998 Received: August 13, 1998

Dear Ms. White:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. ದ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

sincerely yours,
Steven Litman

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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510(k) Number (if known) K972960 Device Name: Uri-Test - Protein in Urine

Indication for Use:

UriTest- Protein in Urine is a non-quantitative screening test to identify protein in urine. Protein in urine can be associated with renal, kidney or bladder disease.

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number k972960

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

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OR

Over The Counter Use
(Optional Format 1-2-96)

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