CREATINE KINASE (CK)

K972155 · Stanbio Laboratory · CGS · Jul 17, 1997 · Clinical Chemistry

Device Facts

• Record ID: K972155
• Device Name: CREATINE KINASE (CK)
• Applicant: Stanbio Laboratory
• Product Code: CGS · Clinical Chemistry
• Decision Date: Jul 17, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Intended Use

Stanbio Laboratory's Creatine Kinase (CK) Liqui-UV 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 serum. Serum creatine kinase (CK) levels have proven valuable in the assessment of cardiac and skeletal muscle diseases, including myocardial infarction and muscular dystrophy.

Device Story

In vitro diagnostic reagent kit for kinetic quantitative determination of Creatine Kinase (CK) in serum; consists of two reagents, CK Buffer (R1) and CK Enzyme (R2). Working reagent prepared by mixing five parts R1 to one part R2. Operates by measuring the rate of NADPH formation, which is proportional to CK activity. Used in clinical laboratory settings by trained personnel. Output is a quantitative measurement of CK activity, used by clinicians to assess cardiac and skeletal muscle conditions, including myocardial infarction and muscular dystrophy.

Clinical Evidence

Bench testing only. Method comparison study performed against predicate device (n not specified) yielded a correlation coefficient of 0.999 and regression equation y = 1.027x - 0.65. Additional bench studies included precision, linearity, sensitivity, stability, and interference testing; all results reported as acceptable.

Technological Characteristics

In vitro diagnostic reagent kit; two-part liquid reagent system (CK Buffer and CK Enzyme). Kinetic enzymatic assay principle measuring NADPH formation rate. Standalone laboratory test kit.

Indications for Use

Indicated for the quantitative determination of creatine kinase (CK) activity in serum to assist in the assessment of cardiac and skeletal muscle diseases, including myocardial infarction and 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.

Predicate Devices

• CK/NAC (Boehringer Mannheim)

Submission Summary (Full Text)

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K972155

JUL 17 1997

## 510(k) SUMMARY

Submitter's Name Kirk Johnson Stanbio Laboratory, Inc. 2930 East Houston Street San Antonio, TX 78202

Tel. [phone] Fax [phone]

Prepared By Kirk Johnson May 30, 1997

Product Name Trade name: Creatine Kinase (CK) Liqui-UV® Common name: Creatine Kinase (CK) Classification name: N-Acetyl-L-Cysteine, Creatine Kinase Class II, 75JFX

Substantial Equivalence of Device This test is substantially equivalent to : Product Name: CK/NAC Manufacturer Boehringer Mannheim

Description of Device

The device test kit is comprised of two reagents, CK Buffer (R1) and CK Enzyme (R2). A working reagent is prepared by combining five parts CK Buffer (R1) to one part CK Enzyme (R2).

Intended Use of Device The device is used for the kinetic quantitative determination of Creatine Kinase (CK) in serum.

Comparison of Devices

Both Creatine Kinase (CK) methods measure kinetically the rate of NADPH formation at a rate proportional to the CK activity.

## Performance Data

Substantial equivalency was demonstrated by method comparison. Correlation was performed between the two test kits with a correlation coefficient of 0.999 and a regression equation of y = 1.027x - 0.65.

In addition, precision, linearity, sensitivity, stability and interference studies were performed on Stanbio Laboratory, Inc., version of Creatine Kinase (CK) Liqui-UV®. Catalog # 2910. Results of these tests were found to be acceptable.

LABORATORY, INC

http://www.stanbio.com

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 1 7 1997

Kirk Johnson FDA Correspondent Stanbio Laboratory, Inc. 2930 E. Houston Street San Antonio, Texas 78202

Re: K972155 Creatine Kinase (CK) Liqui-UV® Requlatory Class: II Product Code: CGS Dated: May 30, 1997 Received: June 5, 1997

Dear Mr. Johnson:

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 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 (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. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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 requlation (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 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 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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510(k) Number (if known):_K972155

Device Name: Creatine Kinase (CK) Liqui-UV

Indications For Use:

Stanbio Laboratory's Creatine Kinase (CK) Liqui-UV 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 serum. Serum creatine kinase (CK) levels have proven valuable in the assessment of cardiac and skeletal muscle diseases, including myocardial infarction and muscular dystrophy.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Prescription Use V (Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)