OLYMPUS URIC ACID REAGENT, MODEL OSR6X98

K062862 · Olympus America, Inc. · KNK · Apr 6, 2007 · Clinical Chemistry

Device Facts

• Record ID: K062862
• Device Name: OLYMPUS URIC ACID REAGENT, MODEL OSR6X98
• Applicant: Olympus America, Inc.
• Product Code: KNK · Clinical Chemistry
• Decision Date: Apr 6, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1775
• Device Class: Class 1

Intended Use

System reagent for the quantitative determination of Uric Acid in human serum, heparinized plasma and urine on OLYMPUS analyzers Measurements of Uric Acid 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

Olympus Uric Acid Reagent is an in vitro diagnostic reagent used on Olympus clinical chemistry analyzers. It enables quantitative measurement of uric acid levels in human serum, heparinized plasma, and urine samples. The device is intended for use by clinical laboratory professionals to assist in the diagnosis and management of renal and metabolic conditions, including gout and renal failure, and to monitor patients undergoing cytotoxic therapy. The reagent facilitates automated biochemical analysis within a clinical laboratory setting, providing quantitative data that informs clinical decision-making regarding patient metabolic status and treatment efficacy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic reagent for quantitative uric acid determination. Designed for use on Olympus automated clinical chemistry analyzers. Principle of operation involves enzymatic or chemical reaction for uric acid quantification in serum, plasma, or urine.

Indications for Use

Indicated for quantitative determination of uric acid in human serum, heparinized plasma, and urine to aid in diagnosis/treatment of renal and metabolic disorders (e.g., renal failure, gout, leukemia, psoriasis, wasting conditions) and monitoring patients on 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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Olympus America, Inc., c/o Ms. Bev Harding 3131 West Royal Lane Irving, TX 75063-3104

APR - 6 2007

Re: k062862 Trade Name: Olympus Uric Acid Reagent Regulation Number: 21 CFR §862.1775 Regulation Name: Uric acid test system. Regulatory Class: Class I (Reserved) Product Code: KNK Dated: February 21, 2007 Received: February 22, 2007

Dear Ms. Harding:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Jean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Olympus Uric Acid Premarket Notification

## Indications for Use

510(k) Number (if known):

Device Name:

## Olympus Uric Acid Reagent

Indications for Use:

System reagent for the quantitative determination of Uric Acid in human serum, heparinized plasma and urine on OLYMPUS analyzers

Measurements of Uric Acid 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.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol Benam

ion Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

062862