DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE

K990873 · Ameritek, Inc. · JMT · Sep 1, 1999 · Clinical Chemistry

Device Facts

• Record ID: K990873
• Device Name: DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE
• Applicant: Ameritek, Inc.
• Product Code: JMT · Clinical Chemistry
• Decision Date: Sep 1, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1510
• Device Class: Class 1

Intended Use

dBest Urinary Tract Infection Test Kit for Home-Use is a simple one step urinalysis assay for rapid, semi-quantitative detection of the presence of Nitrite and Protein in human urine to aid in the diagnosis of urinary track infection. The dBest Urinary Tract Infection Kits are for home-use only.

Device Story

dBest Urinary Tract Infection Test Kit is a one-step, semi-quantitative urinalysis assay; designed for home-use by patients. Device detects Nitrite and Protein in human urine samples; aids in diagnosis of urinary tract infections. User performs test at home; interprets results visually. Provides rapid diagnostic information to assist in clinical decision-making regarding potential infection.

Clinical Evidence

No clinical data provided in the document; bench testing only.

Technological Characteristics

One-step urinalysis assay; semi-quantitative detection of Nitrite and Protein; intended for home-use; non-automated visual test format.

Indications for Use

Indicated for home-use by individuals to aid in the diagnosis of urinary tract infections via semi-quantitative detection of Nitrite and Protein in human urine.

Regulatory Classification

Identification

A nitrite (nonquantitative) test system is a device intended to identify nitrite in urine. Nitrite identification is used in the diagnosis and treatment of uninary tract infection of bacterial origin.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by a series of curved lines that suggest a profile view. The figure is abstract and symbolic, conveying a sense of care and well-being.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP - 1 1999

Mr. K. C. Yee, M.D., Ph.D. President AmeriTek, Inc. 7030 35th Avenue NE Seattle, Washington 98115

Re: K990873

> Trade Name: dBest Urinary Track Infection Test Kit for Home-Use Product Code: JMT Regulatory Class: II Regulatory Class: I Product Code: JIR Dated: June 21, 1999 Received: June 24, 1999

Dear Dr. Yee:

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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 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). 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. A 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 action. In addition, FDA may publish further announcements 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/dsma/dsmamain.html".

Sincerely yours,

Khadir

Image /page/1/Picture/6 description: The image shows a handwritten symbol that resembles a stylized letter 'f' with a tilde above it. The symbol is drawn in black ink on a white background. The 'f' has a curved stem and a loop at the bottom, while the tilde is placed above the stem.

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: 990873

Device Name: dBest Urinary Tract Infection Test Kit for Home-Use

Indications For Use:

dBest Urinary Tract Infection Test Kit for Home-Use is a simple one step urinalysis assay for rapid, semi-quantitative detection of the presence of Nitrite and Protein in human urine to aid in the diagnosis of urinary track infection. The dBest Urinary Tract Infection Kits are for home-use only.

Sean Cooper

(Division Sign-Off) Division of Clinical La 510(k) Number.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PATE IF NEEDEN)

Prescription Use

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OR

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

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