OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279

K043202 · Olympus America, Inc. · CGS · Dec 23, 2004 · Clinical Chemistry

Device Facts

• Record ID: K043202
• Device Name: OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279
• Applicant: Olympus America, Inc.
• Product Code: CGS · Clinical Chemistry
• Decision Date: Dec 23, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Intended Use

The Olympus Creatine Kinase reagent is intended for use in Olympus automated clinical chemistry analyzers for the quantitative determination of creatine kinase activity in human serum and plasma. Measurements of creatine kinase are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

Device Story

Olympus Creatine Kinase Reagent; 3-part liquid reagent kit for use on Olympus automated clinical chemistry analyzers (AU400/AU400e, AU600/AU640/AU640e, AU2700/AU5400). Input: human serum or plasma samples. Principle: enzymatic colorimetric assay; creatine kinase catalyzes conversion of creatine phosphate and ADP to ATP; subsequent hexokinase and G-6-P-dehydrogenase reactions produce NADPH. Output: rate of increase in absorbance at 340/660 nm, proportional to creatine kinase activity (U/L). Used in clinical laboratories by professional staff. Results assist clinicians in diagnosing/monitoring myocardial infarction and muscle disorders. Reagent format modification from 2-part to 3-part liquid reagents to improve stability.

Clinical Evidence

No clinical data provided; substantial equivalence is based on performance characteristics of the reagent for quantitative determination of creatine kinase activity in human serum and plasma.

Technological Characteristics

Quantitative enzymatic colorimetric assay. Reagents: 3-part liquid (buffers, preservatives, stabilizers, enzymes). Analyzers: Olympus AU series (automated). Detection: spectrophotometric (340/660 nm). Standards: NCCLS EP5-A (precision), EP6-P (linearity), EP7-P (interference), EP9-A (method comparison).

Indications for Use

Indicated for quantitative determination of creatine kinase activity in human serum and plasma to aid in diagnosis and treatment of myocardial infarction and muscle diseases, including progressive Duchenne-type muscular dystrophy.

Regulatory Classification

Identification

A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 2 3 2004

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

Re: k043202

Trade/Device Name: Olympus Creatine Kinase Reagent Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: CGS Dated: November 17, 2004 Received: November 18, 2004

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 (OS) 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) I ms lotter will and my Jorne FDA finding of substantial equivalence of your device to a legally premained 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 I ou may ovail 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,

Carol C., Benam for

Cornelia B. Rooks, MA Acting 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):

Olympus Creatine Kinase Reagent. Device Name:

Indications for Use:

The Olympus Creatine Kinase reagent is intended for use in Olympus automated clinical The Organisation of creatify the quantitative determination of creatine kinase activity in human serum and plasma.

Measurements of creatine kinase are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

Carol Benam
Division of Off

Offici- or in Vitro Diganostic e Evaluation and Safety

571338 K043202

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)