JAS URIC ACID LIQUID REAGENT

K012038 · Jas Diagnostics, Inc. · KNK · Aug 21, 2001 · Clinical Chemistry

Device Facts

• Record ID: K012038
• Device Name: JAS URIC ACID LIQUID REAGENT
• Applicant: Jas Diagnostics, Inc.
• Product Code: KNK · Clinical Chemistry
• Decision Date: Aug 21, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1775
• Device Class: Class 1

Intended Use

Intended for the In Vitro, quantitative determination of uric acid in human serum on automated chemistry analyzers. Uric Acid measurements 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.

Device Story

Uric Acid Reagent is an in vitro diagnostic chemical reagent used for the quantitative determination of uric acid in human serum. The device is intended for use on automated chemistry analyzers in clinical laboratory settings. It is operated by laboratory technicians or clinical staff. The reagent reacts with uric acid in the serum sample to produce a measurable signal, allowing for the quantification of uric acid levels. Healthcare providers use these results to assist in the diagnosis and management of renal and metabolic conditions, such as gout and renal failure, and to monitor patients undergoing cytotoxic therapy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic chemical reagent for use on automated chemistry analyzers. Class I, reserved. No specific materials, energy sources, or software algorithms described.

Indications for Use

Indicated for the quantitative determination of uric acid in human serum to aid in the diagnosis and treatment of renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation, wasting conditions, and monitoring patients receiving cytotoxic drugs.

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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AUG 2 1 2001

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. David Johnston Technical Director JAS Diagnostics, Inc. 7220 N. W. 58th Street Miami, Florida 33166

510(k) Number: K012038 Re: Trade/Device Name: Uric Acid Reagent Regulation Number: 862.1775 Regulatory Class: Class I, Reserved Product Code: JHB Dated: June 14, 2001 Received: June 29, 2001

Dear Mr. Johnston:

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 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. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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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This letter will allow you to begin marketing your device as described in your 510(k) premarket This lotton will and it you ding of substantial equivalence of your device to a legally marketed nothroution. - 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 1 If you desire specific acres vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, [phone]. entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small miorination on your respond and Consumer Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

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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K012038

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510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________ Device Name: _________________________________________________________________________________________________________________________________________________________________ Indications for Use:

Intended for the In Vitro, quantitative determination of uric acid in human serum on automated chemistry analyzers.

Uric Acid measurements 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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Kesia Alexander San Juan Cooper

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K012038

OR

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)