CREATINE KINASE LIQUID REAGENT, MODEL C519-440

K072548 · Teco Diagnostics · CGS · Apr 18, 2008 · Clinical Chemistry

Device Facts

• Record ID: K072548
• Device Name: CREATINE KINASE LIQUID REAGENT, MODEL C519-440
• Applicant: Teco Diagnostics
• Product Code: CGS · Clinical Chemistry
• Decision Date: Apr 18, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Intended Use

The Teco Diagnostics Creatine Kinase liquid reagent is intended for in vitro diagnostic test for the quantitative determination of creatine kinase activity in human serum. 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

Teco Diagnostics Creatine Kinase Liquid Reagent is an in vitro diagnostic assay for measuring creatine kinase (CK) activity in human serum. The device utilizes a kinetic method to quantify CK levels. It is intended for use by clinical laboratory professionals to assist in the diagnosis and management of myocardial infarction and various muscle disorders, such as Duchenne-type muscular dystrophy. The reagent is designed for use with automated or semi-automated clinical chemistry analyzers. By providing quantitative data on CK activity, the device enables healthcare providers to assess muscle tissue damage or cardiac events, facilitating timely clinical decision-making and patient monitoring.

Clinical Evidence

No clinical trials performed. Evidence consists of analytical bench testing: precision (within-run CV 0.5-2.1%, between-run CV 1.0-2.5%), linearity (7-1100 IU/L, r²=0.9996), limit of detection (5.5 IU/L), and interference studies (bilirubin, hemoglobin, cholesterol). Method comparison study using 97 patient serum samples against the predicate device yielded a correlation of r=0.9995 and regression Y=1.001X+1.417. Reference range established using 138 normal adults.

Technological Characteristics

Liquid reagent for kinetic enzymatic assay of creatine kinase in human serum. Designed for use on clinical chemistry analyzers. Standard in vitro diagnostic reagent formulation.

Indications for Use

Indicated for the quantitative determination of creatine kinase activity in human serum to aid in the 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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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Teco Diagnostics c/o Ms. Kelly Chen 1268 N. Lakeview Avenue Anaheim, CA 92807

APR 1 8 2008

k072548 Re:

Trade/Device Name: Creatine Kinase Liquid Reagent (Kinetic Method) Regulation Number: 21 CFR §862.1215 Regulation Name: Creatine Phosphokinase/Creatine Kinase or Isoenzymes Test System. Regulatory Class: Class II Product Code: CGS Dated: March 12, 2008 Received: March 14, 2008

Dear Ms. Chen:

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 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 at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Jean M. Cooper, M.S., 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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## Indication for Use

510 (K) Number (if known): k072548

## Device Name: Creatine Kinase Liquid Reagent (Kinetic Method)

Indications for Use: "The Teco Diagnostics Creatine Kinase liquid reagent is intended for in vitro diagnostic test for the quantitative determination of creatine kinase activity in human serum. Measurements of creatine kinase are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. "

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

Over-The-Counter Use (21 CFR 801 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)

Division Sign-Off

Office of In Vito Diagnostic Device Evaluation and Sat