PARAMAX CHOLESTEROL REAGENT

K964660 · Dade Intl., Inc. · CHH · Jun 4, 1997 · Clinical Chemistry

Device Facts

• Record ID: K964660
• Device Name: PARAMAX CHOLESTEROL REAGENT
• Applicant: Dade Intl., Inc.
• Product Code: CHH · Clinical Chemistry
• Decision Date: Jun 4, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1175
• Device Class: Class 1

Indications for Use

For quantitative determination of cholesterol or HDL cholesterol in plasma or serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipoprotein metabolism disorders¹.

Device Story

Paramax® Cholesterol Reagent is an in vitro diagnostic reagent used for the quantitative determination of cholesterol and HDL cholesterol in human plasma or serum. The device utilizes colorimetric methodology to measure cholesterol levels. It is intended for use by clinical laboratory professionals to assist in the diagnosis and treatment of patients with disorders involving excess cholesterol or lipoprotein metabolism. The reagent is processed on the Paramax® system, which provides quantitative results to the clinician. These results are used to assess lipid profiles and guide clinical decision-making regarding the management of metabolic disorders.

Clinical Evidence

Bench testing only. Correlation study performed comparing Paramax® Cholesterol Reagent to DuPont aca Cholesterol Reagent. Cholesterol analysis used 48 specimens (r=0.984; regression: y=1.10x-7.1). HDL cholesterol analysis used 100 specimens (r=0.9881; regression: y=1.012x-2.27).

Technological Characteristics

Colorimetric assay reagent for quantitative cholesterol and HDL cholesterol determination. Designed for use on the Paramax® system. Technological characteristics are similar to the predicate DuPont aca Cholesterol Reagent.

Indications for Use

Indicated for the quantitative determination of cholesterol or HDL cholesterol in plasma or serum for patients with disorders involving excess blood cholesterol or lipoprotein metabolism disorders.

Regulatory Classification

Identification

A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

Predicate Devices

• DuPont aca Cholesterol Reagent

Submission Summary (Full Text)

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JUN - 4 1997
K964660

# 510(k) Summary of Safety and Effectiveness Information

The Paramax® Cholesterol Reagent is substantially equivalent to DuPont aca Cholesterol Reagent, which was cleared to market on unknown. The proposed and the predicate device are intended for use in the quantitative determination of Cholesterol and HDL Cholesterol.

The Paramax® Cholesterol Reagent and DuPont aca Cholesterol Reagent are based on colormetic methodology.

The technological characteristics of the predicate device are similar to those previously described for the proposed device.

The correlation between the Paramax® Cholesterol Reagent and DuPont aca Cholesterol Reagent was demonstrated by assaying 48 specimens using the Paramax® and DuPont aca Systems. The correlation coefficient for Cholesterol was 0.984, and the regression equation was Paramax® value = (1.10 * aca value) - 7.1. For the HDLC, 100 specimens using Paramax® and DuPont aca Systems yielded a correlation coefficient of 0.9881 and a regression equation of Paramax® value = (1.012 * aca value) -2.27. The data indicates that the results obtained by both reagents are substantially equivalent.

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
2098 Gaither Road
Rockville MD 20850

JUN - 4 1997

Marilyn S. Waxburg
Director
Regulatory Affairs
Dade International, Inc.
9750 N.W. 25th Street
Miami, FL 33172

Re: K964660/S001
Paramax® Cholesterol Reagent
Regulatory Class: I
Product Code: CHH
Dated: March 20, 1997
Received: March 21, 1997

Dear Ms. Waxburg:

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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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/dsmamain.html".

Sincerely yours,

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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Statement of Indications for Use

510(k) Number (if known):

Device Name: Paramax® Cholesterol Reagent

Indication(s) for Use:

Intended Use
For quantitative determination of cholesterol or HDL cholesterol in plasma or serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipoprotein metabolism disorders¹.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use XX
(Per 21 CFR 801.109)
(Optional Format 1-2-96)

OR Over-the-Counter Use
(Division Size-Off)
Division of Current Laboratory Devices
510(k) Number R 964660