OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117

K061575 · Olympus America, Inc. · CJY · Oct 5, 2006 · Clinical Chemistry

Device Facts

• Record ID: K061575
• Device Name: OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117
• Applicant: Olympus America, Inc.
• Product Code: CJY · Clinical Chemistry
• Decision Date: Oct 5, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1145
• Device Class: Class 2

Intended Use

Reagent for the quantitative determination of calcium in human serum, plasma and urine on automated clinical chemistry analyzers.

Device Story

Reagent kit for quantitative calcium measurement; utilizes Arsenazo III colorimetric assay; input: human serum, plasma, or urine samples; operation: automated clinical chemistry analyzers (Olympus AU series); principle: calcium ions react with Arsenazo III to form purple complex; absorbance measured bichromatically at 660/700nm; output: calcium concentration; clinical use: diagnosis/treatment of parathyroid, bone, and renal diseases; healthcare provider uses results to assess calcium homeostasis; benefits: provides rapid, automated diagnostic data for metabolic disorders.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and performance characteristics of the reagent system.

Technological Characteristics

Reagent composition: 0.1-0.2% Arsenazo III, imidazol (pH 6.9), Triton X-100, preservatives. Sensing principle: bichromatic absorbance photometry (660/700nm). Form factor: liquid reagent for automated clinical chemistry analyzers (Olympus AU400/600/640/2700/5400). Connectivity: integrated with analyzer software. Standards: CLSI EP09-A2, EP7-A, EP5-A, EP6-A.

Indications for Use

Indicated for the quantitative determination of calcium in human serum, plasma, and urine to aid in the diagnosis and treatment of parathyroid disease, bone diseases, chronic renal disease, and tetany.

Regulatory Classification

Identification

A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Bev Harding RA Analyst Olympus America, Inc. 3131 West Royal Lane Irving, TX 75063-3104

CT - 5 2006

k061575 Re:

Trade/Device Name: Olympus Calcium Arsenazo Reagent Regulation Number: 21 CFR 862.1145 Regulation Name: Calcium test system Regulatory Class: Class II Product Code: CJY Dated: August 17, 2006 Received: August 18, 2006

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 1egally 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/industry/support/index.html.

Sincerely yours.

Alberto Garcia

Alberto Guticarez, Ph.D. 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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## Indications for Use

510(k) Number (if known): K061575

Olympus Calcium Arsenazo Reagent Device Name:

Indications for Use:

OLYMPUS System reagent for the quantitative determination of calcium concentrations in human serum, plasma and urine on OLYMPUS analyzers.

Measurement of calcium is used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

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

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

and the control control control controlled in the consideration of the consistence in

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

Division/Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)_ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------