URINALYSIS REAGENT STRIPS (10 PARAMETERS)

K993850 · International Newtech Development, Inc. · JMT · Jan 3, 2000 · Clinical Chemistry

Device Facts

• Record ID: K993850
• Device Name: URINALYSIS REAGENT STRIPS (10 PARAMETERS)
• Applicant: International Newtech Development, Inc.
• Product Code: JMT · Clinical Chemistry
• Decision Date: Jan 3, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1510
• Device Class: Class 1

Intended Use

Urinalysis Reagent Strips provide tests for glucose, bilirubin, ketone, specific gravity, blood, pH, protein, urobilinogen, nitrite and leucocytes in urine.

Device Story

Urinalysis Reagent Strips consist of chemical reagent pads affixed to a plastic strip. Device used for in vitro diagnostic testing of urine samples. Operator (clinician or patient) dips strip into urine specimen; color changes on reagent pads indicate presence/concentration of analytes (glucose, bilirubin, ketone, specific gravity, blood, pH, protein, urobilinogen, nitrite, leucocytes). Results obtained via visual comparison against color chart provided on product label. Output assists healthcare providers in screening for metabolic, liver, kidney, and urinary tract conditions. Facilitates rapid clinical decision-making regarding further diagnostic testing or treatment.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and performance verification of the chemical reagent strips against established standards for urinalysis diagnostic accuracy.

Technological Characteristics

Plastic strip substrate with multiple chemical reagent pads. Sensing principle: colorimetric chemical reaction between urine analytes and reagents. Form factor: handheld test strip. No electronic components, connectivity, or software. Sterilization: not applicable (non-sterile in vitro diagnostic).

Indications for Use

Indicated for the qualitative and semi-quantitative detection of glucose, bilirubin, ketone, specific gravity, blood, pH, protein, urobilinogen, nitrite, and leucocytes in human urine samples.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a stylized image of a bird or other winged creature, with three distinct lines forming the body and wings. The overall design is simple and clean, with a focus on the text and the central image.

## JAN - 3 2000

Mr. Dennis S. Hong, B.Sc., B.M.L.Sc. Vice President International Newtech Development Inc. 1629 Fosters Way Delta, BC V3M 6S7 CANADA

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Re: K993850

> Trade Name: Urinalysis Reagent Strips (10 Parameters) Regulatory Class: II Product Code: JIL, JIO Regulatory Class: I Product Code: JMT, JIN, CIN, JMA, JIR, JJB, CDM, JMZ Dated: November 4, 1999 Received: November 12, 1999

Dear Mr. Hong:

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,

Steven Putman

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): _

Urinalysis Reagent Strips (10 Parameters) Device Name:

29938.5

Indications For Use:

Urinalysis Reagent Strips provide tests for glucose, bilirubin, ketone, specific gravity, blood, pH, protein, urobilinogen, nitrite and leucocytes in urine.

> Dennis S.L. Hong, B.Sc., B.M.L.Sc. Vice-President International Newtech Development Inc.

Dan Coogler

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K993850

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Formal 1-2-96)