REP CHOLESTEROL PROFILE TEMPLATE-30, -16, -8; REP VIS CHOLESTEROL

K980650 · Helena Laboratories · JHO · May 1, 1998 · Clinical Chemistry

Device Facts

• Record ID: K980650
• Device Name: REP CHOLESTEROL PROFILE TEMPLATE-30, -16, -8; REP VIS CHOLESTEROL
• Applicant: Helena Laboratories
• Product Code: JHO · Clinical Chemistry
• Decision Date: May 1, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1475
• Device Class: Class 1

Intended Use

The Cholesterol test system is useful in monitoring LDL and HDL cholesterol levels. Patients at risk include males over 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 patients' number of risk factors, treatment can be medication or diet restrictions.

Device Story

The REP Cholesterol Profile Template and REP Vis Cholesterol systems are in vitro diagnostic test systems used to monitor LDL and HDL cholesterol levels. These devices are intended for use in clinical laboratory settings by trained personnel. The system processes patient samples to provide quantitative cholesterol measurements. Healthcare providers use these results to assess cardiovascular risk and guide clinical management, such as dietary restrictions or medication therapy, for patients with risk factors including age, family history, hypertension, diabetes, or smoking status.

Technological Characteristics

In vitro diagnostic test system for cholesterol monitoring. Specific materials, sensing principles, and software details are not provided in the document.

Indications for Use

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

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 Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a caduceus, a symbol often associated with medicine and healthcare.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 1 1998

Pat Franks Assistant Director, Regulatory Affairs Helena Laboratories 1530 Lindbergh Drive P.O. Box 752 77704-0752 Beaumont, Texas

K980650 Re : REP Cholesterol Profile Template-30, 16, 8, and REP Vis Cholesterol I & II Requlatory Class: Product Code: JHO, LBT February 11, 1998 Dated: Received: February 19, 1998

Dear Ms. Franks:

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. 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 requlation (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 In addition, FDA may publish further announcements action. 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/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):

REP Cholesterol Profile Template-30, Cat. No. 3223 Device Name: REP Cholesterol Profile Template-16, Cat. No. 3224 REP Cholesterol Profile Template-8, Cat. No. 3225 REP Vis Cholesterol, Cat. No. 3228

Indications for Use:

The Cholesterol test system is useful in monitoring LDL and HDL cholesterol levels. Patients at risk include males over 45 years and females over 55 years, those with family history of coronary heart disease, strokes, hypertension or diabetes and those who Depending on a patients' number of risk factors, treatment smoke. can be medication or diet restrictions.

(Division Sign-Off)
Division of Clinical Laboratory vices
510(k) Number K980650

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

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