OLYMPUS CK-MB REAGENT

K971817 · Olympus America, Inc. · JLB · Jun 11, 1997 · Clinical Chemistry

Device Facts

• Record ID: K971817
• Device Name: OLYMPUS CK-MB REAGENT
• Applicant: Olympus America, Inc.
• Product Code: JLB · Clinical Chemistry
• Decision Date: Jun 11, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1210
• Device Class: Class 1

Intended Use

The Olympus Creatine Kinase MB reagent is for the quantitative determination of Creatine Kinase-MB isoenzyme in human serum on Olympus analyzers.

Device Story

Olympus Creatine Kinase-MB (CK-MB) reagent is an in vitro diagnostic assay designed for use on Olympus clinical chemistry analyzers. The device measures CK-MB isoenzyme levels in human serum samples. It is intended for use by laboratory professionals in clinical settings to assist in the assessment of cardiac conditions. The reagent facilitates quantitative analysis, providing results that healthcare providers use to aid in clinical decision-making regarding patient cardiac health. The device operates within the established workflow of automated clinical chemistry analyzers.

Clinical Evidence

No clinical data provided; the submission relies on the determination of substantial equivalence to existing legally marketed devices.

Technological Characteristics

In vitro diagnostic reagent for quantitative determination of CK-MB isoenzyme. Designed for use on automated Olympus clinical chemistry analyzers. Chemical assay principle.

Indications for Use

Indicated for the quantitative determination of Creatine Kinase-MB isoenzyme in human serum for clinical diagnostic use on Olympus analyzers.

Regulatory Classification

Identification

A creatine test system is a device intended to measure creatine (a substance synthesized in the liver and pancreas and found in biological fluids) in plasma, serum, and urine. Measurements of creatine are used in the diagnosis and treatment of muscle diseases and endocrine disorders including hyperthyroidism.

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

JUN 11 1997 Laura Storms-Tyler Director, Regulatory Affairs Olympus America, Inc. ........................................................................................................................................................ Two Corporate Center Drive Melville, New York 11747-3157

Re : K971817 Olympus CK-MB Reagent Requlatory Class: II Product Code: JLB Dated: May 15, 1997 Received: May 16, 1997

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, Druq, 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 reqistration, 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 requlations 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) requlation (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 requlation may result in requlatory 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 requlations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CIIA complexity (CLIA-88), Chis device may require 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 general 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 Bitman

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):

Not assigned yet

Device Name:

Olympus Creatine Kinase-MB Reagent

Indications for Use:

The Olympus Creatine Kinase MB reagent is for the quantitative determination of Creatine Kinase-MB isoenzyme in human serum on Olympus analyzers.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (per 21CFR 801 109)

OR

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

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number 4971812