REP CHOLESTEROL PROFILE KIT

K992971 · Helena Laboratories · JHO · Oct 18, 1999 · Clinical Chemistry

Device Facts

• Record ID: K992971
• Device Name: REP CHOLESTEROL PROFILE KIT
• Applicant: Helena Laboratories
• Product Code: JHO · Clinical Chemistry
• Decision Date: Oct 18, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1475
• Device Class: Class 1

Intended Use

The Cholesterol Profile test system is useful in monitoring LDL, VIDI, and Lp(a)-C cholesterol when present in concentrations HDL. However in some patients Lp(a)-C may not be greater than 2.5 mg/dL. present at concentrations detectable by electrophoresis. Patients at risk include males over the age of 45 years and females over 55 years, those with family history of coronary heart disease, strokes, hypertension or diabetes and those who smoke. Depending on a patient's number of risk factors, treatment can be medication or diet restrictions.

Device Story

REP Cholesterol Profile Kit is an in vitro diagnostic test system used to monitor cholesterol fractions (LDL, VLDL, Lp(a)-C). The device utilizes electrophoresis to separate and quantify cholesterol concentrations in patient samples. It is intended for use by healthcare professionals in clinical laboratory settings to assess cardiovascular risk factors. Results are provided to clinicians to guide patient management, which may include dietary modifications or pharmacological interventions. The system assists in identifying patients requiring treatment based on their specific risk profile.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

In vitro diagnostic test system utilizing electrophoresis for the separation and quantification of cholesterol fractions. Operates as a laboratory-based diagnostic device.

Indications for Use

Indicated for monitoring LDL, VLDL, and Lp(a)-C cholesterol levels in patients at risk for coronary heart disease, including males >45 years, females >55 years, smokers, and individuals with family history of heart disease, stroke, hypertension, or diabetes.

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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 1 8 1999

Mr. Eric Petersen Vice President Helena Labs 1530 Lindbergh Drive Beaumont, Texas 77704

Re: K992971

> Trade Name: REP® Cholesterol Profile Kit Regulatory Class: I Product Code: JHO Dated: August 31, 1999 Received: September 3, 1999

Dear Mr. Petersen:

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 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). 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 vour device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (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 Register. 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 regulations.

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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 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"(21 CFR 807.97). 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/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

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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8 9 510 (k) Number (if known) : REPR Cholesterol Profile Kit Device Name:

Indications for Use:

The Cholesterol Profile test system is useful in monitoring LDL, VIDI, and Lp(a)-C cholesterol when present in concentrations HDL. However in some patients Lp(a)-C may not be greater than 2.5 mg/dL. present at concentrations detectable by electrophoresis. Patients at risk include males over the age of 45 years and females over 55 years, those with family history of coronary heart disease, strokes, hypertension or diabetes and those who smoke. Depending on a patient's number of risk factors, treatment can be medication or diet restrictions.

Jean Corper

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number KG92971

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

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

V Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)