URIC ACID, MODEL UA112-01

K991247 · A.P. Total Care, Inc. · KNK · May 25, 1999 · Clinical Chemistry

Device Facts

• Record ID: K991247
• Device Name: URIC ACID, MODEL UA112-01
• Applicant: A.P. Total Care, Inc.
• Product Code: KNK · Clinical Chemistry
• Decision Date: May 25, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1775
• Device Class: Class 1

Intended Use

The Uric Acid reagent reagent, product No. UA112-01 is intended for Invitro Diagnostic use in the automated, quantitative determination of Uric Acis in serum, or plasma.

Device Story

Uric Acid reagent (product No. UA112-01) is an in vitro diagnostic reagent used for the quantitative measurement of uric acid levels in human serum or plasma samples. The device is intended for use in clinical laboratory settings on automated chemistry analyzers. It is operated by laboratory professionals. The output is a quantitative concentration value of uric acid, which assists clinicians in the diagnosis and management of conditions associated with hyperuricemia or hypouricemia, such as gout or renal disease.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic chemical reagent for automated quantitative analysis of uric acid in serum or plasma. Operates via standard clinical chemistry analyzer platforms.

Indications for Use

Indicated for the automated, quantitative determination of Uric Acid in human serum or plasma for in vitro diagnostic use.

Regulatory Classification

Identification

A uric acid test system is a device intended to measure uric acid in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.

MAY 25 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

A.P. Total Care, Inc. Luis P. Leon c/o Catachem, Inc. 70 Hawley Avenue P.O. Box 6216 Bridgeport, CT

Re: K991247 Trade Name: Uric Acid Requlatory Class: II Product Code: KNK April 7, 1999 Dated: April 12, 1999 Received:

Dear Mr. Leon:

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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls The general controls provisions of the provisions of the Act. 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 A substantially Requlations, Title 21, Parts 800 to 895. 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 Sutman

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):_____________________________________________________________________________________________________________________________________________________ Uric Acid Device Name: _

Indications For Use:

The Uric Acid reagent reagent, product No. UA112-01 is intended for Invitro Diagnostic use in the automated, quantitative determination of Uric Acis in serum, or plasma.

Jean Cooper

(Division Sign-Off)
Division of Clini

510(k) Murat K991247

(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 Format 1-2-96)