SPIFE CK KIT, MODEL 3332, 3333

K022757 · Helena Laboratories · JHY · Oct 11, 2002 · Clinical Chemistry

Device Facts

• Record ID: K022757
• Device Name: SPIFE CK KIT, MODEL 3332, 3333
• Applicant: Helena Laboratories
• Product Code: JHY · Clinical Chemistry
• Decision Date: Oct 11, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Intended Use

The SPIFE CK Kit is used in the identification and quantitation of serum creatine kinase isoenzymes. This test is especially useful in detecting acute myocardial infarction (AMI) when used in conjunction with LD isoenzyme studies.

Device Story

The SPIFE CK Kit is an in vitro diagnostic test system used in clinical laboratories to identify and quantify creatine kinase (CK) isoenzymes in serum samples. The device utilizes electrophoresis to separate CK isoenzymes, allowing for the detection of specific patterns associated with acute myocardial infarction (AMI). It is intended for use by trained laboratory personnel. The results are interpreted by clinicians to aid in the diagnosis of AMI, typically in conjunction with lactate dehydrogenase (LD) isoenzyme studies. The device provides quantitative data that supports clinical decision-making regarding cardiac health.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and performance characteristics of the electrophoresis test system.

Technological Characteristics

Electrophoresis-based test system for CK isoenzyme separation and quantification. Designed for use with the SPIFE system. In vitro diagnostic device, Class II, Product Code JHY.

Indications for Use

Indicated for the identification and quantitation of serum creatine kinase (CK) isoenzymes to assist in the detection of acute myocardial infarction (AMI) in patients, when used in conjunction with LD isoenzyme studies.

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

Ms. Patricia Franks Assistant Director of Regulatory Affairs Helena Laboratories, Inc. 1530 Lindbergh Drive P.O. Box 752 Beaumont, TX 77704-0752

OCT 1 1 2002

k022757 Re:

> Trade/Device Name: SPIFE CK Kit Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: JHY Dated: August 15, 2002 Received: August 20, 2002

Dear Ms. Franks:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrb/dsmaldsmamain.html".

Sincerely yours,

Steven Butman

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): ΚΟΣΣ 757

Device Name: SPIFE CK Kit

Indications for Use:

The SPIFE CK Kit is used in the identification and quantitation of serum creatine kinase isoenzymes. This test is especially useful in detecting acute myocardial infarction (AMI) when used in conjunction with LD isoenzyme studies.

Cooges

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number KA22757

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

And Children Children

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

and the state of the state of the subject of

OR

Over-The-Counter Use

(Optional Format 1-2-96)

the state of the state of the state of the state of the states and the second