SPIFE LIPPOROTEIN-12, MODEL 3344

K022333 · Helena Laboratories · JHO · Aug 15, 2002 · Clinical Chemistry

Device Facts

• Record ID: K022333
• Device Name: SPIFE LIPPOROTEIN-12, MODEL 3344
• Applicant: Helena Laboratories
• Product Code: JHO · Clinical Chemistry
• Decision Date: Aug 15, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1475
• Device Class: Class 1

Indications for Use

The SPIFE Lipoprotein-12 System is intended for the separation and quantitation of serum or plasma lipoproteins used in the diagnosis and treatment of lipid disorders, atherosclerosis, and various liver and renal diseases.

Device Story

The SPIFE Lipoprotein-12 System is an automated laboratory instrument designed for the separation and quantitation of serum or plasma lipoproteins. It is used in clinical laboratory settings by trained laboratory personnel. The system processes patient samples to perform electrophoresis, separating lipoprotein fractions. The resulting data is used by clinicians to diagnose and monitor lipid disorders, atherosclerosis, and associated liver or renal conditions. The device provides quantitative results that aid in clinical decision-making regarding patient lipid management and treatment strategies.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory review of the device's intended use and technological characteristics as a lipoprotein test system.

Technological Characteristics

Automated electrophoresis system for lipoprotein separation and quantitation. Operates as a clinical laboratory instrument. Class I, reserved, product code JHO.

Indications for Use

Indicated for the separation and quantitation of serum or plasma lipoproteins to assist in the diagnosis and treatment of lipid disorders, atherosclerosis, and various liver and renal diseases in patients requiring clinical laboratory lipid testing.

Regulatory Classification

Identification

A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 1 5 2002

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

Re: k022333

> Trade/Device Name: SPIFE Lipoprotein-12 System Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein test system Regulatory Class: Class I, reserved Product Code: JHO Dated: July 10, 2002 Received: July 18, 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. Iisting 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/cdrb/dsma/dsmamain.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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< 0 22 2 3 3 510 (k) Number (if known) :

Device Name. SPIFE Lipoprotein-12 System

Indications for Use:

The SPIFE Lipoprotein-12 System is intended for the separation and quantitation of serum or plasma lipoproteins used in the diagnosis and treatment of lipid disorders, atherosclerosis, and various liver and renal diseases.

Jean Cooper

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K022333

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

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ﻠﺴ (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)