OLYMPUS URINE CALIBRATOR

K033910 · Cliniqa Corporation · JIX · Jan 30, 2004 · Clinical Chemistry

Device Facts

• Record ID: K033910
• Device Name: OLYMPUS URINE CALIBRATOR
• Applicant: Cliniqa Corporation
• Product Code: JIX · Clinical Chemistry
• Decision Date: Jan 30, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

Olympus™ Urine Calibrator is intended for use in the calibration of quantitative chemistry assays including Amylase, Calcium, Creatinine, Glucose, Magnesium, Phosphorus, Urea, and Total Protein on the Olympus™ series of chemistry analyzers.

Device Story

Olympus™ Urine Calibrator is an assayed, liquid, human urine-based product; supplied in 5 mL vials. Used in clinical laboratory settings to calibrate quantitative chemistry assays on Olympus series analyzers. Provides reference values for specific analytes to ensure accuracy of patient sample testing. Value assignment performed using Olympus analyzers and reagents; traceable to NIST and CAP reference materials/methods.

Clinical Evidence

No clinical data. Bench testing only; value assignment established via Olympus testing protocols using Olympus analyzers and reagents; traceability to NIST and CAP standards.

Technological Characteristics

Liquid, human urine-based calibrator. Designed for use on Olympus™ series chemistry analyzers. Standardized for specific quantitative urine chemistry assays. No electronic, software, or energy-based components.

Indications for Use

Indicated for the calibration of quantitative urine chemistry assays (Amylase, Calcium, Creatinine, Glucose, Magnesium, Phosphorus, Urea, Total Protein) on Olympus™ series chemistry analyzers in a clinical laboratory setting.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 3 0 2004

Ms. Carol Ruggiero Director of Regulatory Affairs CLINIQA Corporation 1432 South Mission Road Fallbrook, CA 92028

Re: k033910

Trade/Device Name: Olympus™ Urine Calibrator Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: December 15, 2003 Received: December 17, 2003

Dear Ms. Ruggiero:

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 r ou mays 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 If your de roo to enabled (tional 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 r that FDA has made a determination that your device complies with other requirements of the Act that + Dr Hoss Internand regulations administered by other Federal agencies. You must or any I coolar batates and weather ments, 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 http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Jean M. Cooper, MS, DVM.

Yean M. Cooper, MS. 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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510(k) Number (if known): K033) | O

Device Name: Olympus™ Urine Calibrator

Indications For Use:

Olympus™ Urine Calibrator is intended for use in the calibration of quantitative chemistry ormpuo - Ghine Calinse, Calcium, Creatinine, Glucose, Magnesium, Phosphorus, Urea assays including / infylaso, Salolan, Grounner, Stall Protein on the Olympus™ series of chemistry analyzers.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Carol C. Benamfor Jean Cooper, DVM
Division Sign-Off

Office of In Vitro Diagnostic Device Evalu tion and Safety

510(k) K033910

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use