OLYMPUS CALCIUM ARSENAZO III REAGENT

K982035 · Olympus Diagnostica GmbH · CJY · Jun 24, 1998 · Clinical Chemistry

Device Facts

• Record ID: K982035
• Device Name: OLYMPUS CALCIUM ARSENAZO III REAGENT
• Applicant: Olympus Diagnostica GmbH
• Product Code: CJY · Clinical Chemistry
• Decision Date: Jun 24, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1145
• Device Class: Class 2

Intended Use

The Olympus Calcium Arsenazo Reagent is intended for the quantitative determination of Calcium concentrations in human serum on Olympus clinical chemistry analyzers.

Device Story

Olympus Calcium Arsenazo Reagent is an in vitro diagnostic reagent used for the quantitative measurement of calcium levels in human serum. The device is designed for use on Olympus clinical chemistry analyzers. It functions by reacting with calcium in the serum sample to produce a measurable colorimetric change, which the analyzer detects to calculate the calcium concentration. The output is a quantitative value provided to clinicians to assist in the diagnosis and monitoring of calcium-related metabolic disorders. It is intended for professional use in clinical laboratory settings.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic reagent utilizing the Arsenazo III dye-binding method for calcium quantification. Designed for automated analysis on Olympus clinical chemistry platforms. Reagent composition and stability are consistent with standard clinical chemistry diagnostic requirements.

Indications for Use

Indicated for the quantitative determination of calcium concentrations in human serum for clinical diagnostic purposes.

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

JUN 24 1998

Laura Storms-Tyler . Director, Regulatory Affairs Olympus America, Inc. Two Corporate Center Drive Melville, New York 11747

K982035 Re: Olympus Calcium Arsenazo Reagent Requlatory Class: II Product Code: CJY June 9, 1998 Dated: Received: June 10, 1998

Dear Ms. Storms-Tyler:

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 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 The general controls provisions of the Act 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 Current Good Manufacturing Practice requirements, as setforth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Failure to Administration (FDA) will verify such assumptions. comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. 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 requlations.

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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 qeneral 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/dsmamain.html".

Sincerely yours,
Steven Litman

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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## Indications for Use Statement

510(k) Number (if known):

x 9820 35 Not assigned yet

Device Name:

Olympus Calcium Arsenazo Reagent

Indications for Use:

The Olympus Calcium Arsenazo Reagent is intended for the quantitative determination of Calcium concentrations in human serum on Olympus clinical chemistry analyzers.

| (Division Sign-Off) | |
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| Division of Clinical Laboratory Devices | |
| 510(k) Number | k 982035 |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use __ V ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(per 21CFR 801.109)

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Over-the Counter Use (Optional Format 1-2-96)