SPIFE LD-12 KIT, MODEL 3338

K022455 · Helena Laboratories · CFE · Oct 1, 2002 · Clinical Chemistry

Device Facts

• Record ID: K022455
• Device Name: SPIFE LD-12 KIT, MODEL 3338
• Applicant: Helena Laboratories
• Product Code: CFE · Clinical Chemistry
• Decision Date: Oct 1, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1445
• Device Class: Class 2

Intended Use

The SPIFE LD test system can be used in conjunction with CK isoenzyme studies to aid in the diagnosis of myocardial infarction. The LD1/LD2 "flip" can be present in patients after acute MI, severe anemias, renal necrosis and in-vivo or in-vitro hemolysis of any cause. The LD5 is increased in skeletal muscle injury or diseases, cirrhosis, hepatitis and passive liver congestion. Mid-zone fractions (LD2,3,4) are increased in cases of massive platelet destruction (pulmonary embolism) and in lymphatic system involvements such as mononucleosis, lymphomas and lymphocytic leukemias.

Device Story

SPIFE LD-12 Isoenzyme Kit is an in vitro diagnostic test system used in clinical laboratories. It performs electrophoretic separation of lactate dehydrogenase (LD) isoenzymes from human serum samples. The system utilizes the SPIFE electrophoresis platform to separate LD isoenzymes, which are then visualized and quantified. Clinicians use the resulting isoenzyme patterns (e.g., LD1/LD2 flip, LD5 elevation) to assist in diagnosing myocardial infarction, liver disease, muscle injury, and other conditions involving tissue damage or hemolysis. The device provides objective data to support clinical decision-making regarding patient diagnosis and management.

Clinical Evidence

No clinical data provided in the document; substantial equivalence is based on the device's intended use and technological characteristics as a standard laboratory test system.

Technological Characteristics

Electrophoretic test system for lactate dehydrogenase isoenzymes. Operates via electrophoresis to separate isoenzyme fractions. Class II device (21 CFR 862.1445).

Indications for Use

Indicated for use in conjunction with CK isoenzyme studies to aid in the diagnosis of myocardial infarction. Applicable to patients presenting with conditions associated with LD isoenzyme variations, including acute MI, severe anemias, renal necrosis, hemolysis, skeletal muscle injury, cirrhosis, hepatitis, liver congestion, pulmonary embolism, mononucleosis, lymphomas, and lymphocytic leukemias.

Regulatory Classification

Identification

A lactate dehydrogenase isoenzymes test system is a device intended to measure the activity of lactate dehydrogenase isoenzymes (a group of enzymes with similar biological activity) in serum. Measurements of lactate dehydrogenase isoenzymes are used in the diagnosis and treatment of liver diseases, such as viral hepatitis, and myocardial infarction.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

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

Ms. Patricia Franks Assistant Director of Regulatory Affairs Helena Laboratories, Inc. 1530 Lindbergh Drive P.O. Box 752 Beaumont, TX 7704-0752

OCT 01 2002

Re: k022455

> Trade/Device Name: SPIFE LD-12 Isoenzyme Kit Regulation Number: 21 CFR 862.1445 Regulation Name: Lactate dehydrogenase isoenzymes test system Regulatory Class: Class II Product Code: CFE Dated: July 19, 2002 Received: July 26, 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 (QS) 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/cdrlvdsmamain.html".

Sincerely yours,

Steven Putman

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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Page of

K022455

510(k) Number (if known):

SPIFE LD-12 Isoenzyme Kit Device Name:

Indications for Use:

The SPIFE LD test system can be used in conjunction with CK isoenzyme studies to aid in the diagnosis of myocardial infarction. The LD1/LD2 "flip" can be present in patients after acute MI, severe anemias, renal necrosis and in-vivo or in-vitro hemolysis of any cause.

The LD5 is increased in skeletal muscle injury or diseases, cirrhosis, hepatitis and passive liver congestion.

Mid-zone fractions (LD2,3,4) are increased in cases of massive platelet destruction (pulmonary embolism) and in lymphatic system involvements such as mononucleosis, lymphomas and lymphocytic leukemias.

Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K022455

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)