AUTOMATED HDL CHOLESTEROL FLEX REAGENT CARTRIDGE, MODEL DF48A

K053157 · Dade Behring, Inc. · LBS · Dec 9, 2005 · Clinical Chemistry

Device Facts

• Record ID: K053157
• Device Name: AUTOMATED HDL CHOLESTEROL FLEX REAGENT CARTRIDGE, MODEL DF48A
• Applicant: Dade Behring, Inc.
• Product Code: LBS · Clinical Chemistry
• Decision Date: Dec 9, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1475
• Device Class: Class 1

Intended Use

The HDL Flex Reagent Cartridge is intended for the quantitative determination of high-density lipoprotein cholesterol (HDL-C) in human serum and plasma on the Dimension clinical chemistry system.

Device Story

HDL Flex Reagent Cartridge; in vitro diagnostic reagent for quantitative HDL-C measurement; used on Dimension clinical chemistry systems; operates via automated chemical assay; input: human serum or plasma samples; output: quantitative HDL-C concentration; assists clinicians in lipid profile assessment and cardiovascular risk evaluation; modification involves adjusting lowest calibrator concentration from 10 mg/dL to 0 mg/dL and removing CRMLN certification statement; system provides results for clinical decision-making at medical decision points of 40 and 60 mg/dL.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic reagent cartridge for automated clinical chemistry analysis. Calibrator concentrations: 0, 40, and 165 mg/dL cholesterol. Designed for use on Dimension clinical chemistry systems.

Indications for Use

Indicated for the quantitative measurement of high density lipoprotein cholesterol (HDL-C) in human serum and plasma to aid in the diagnosis of lipid disorders.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus. The seal is black and white.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

2005 DEC 9

Mr. Victor M. Carrio Regulatory Affairs and Compliance Manager Dade Behring Inc. Glasgow Business Community P.O. Box 6101, Bldg 500 Newark, DE 19714

Re: k053157

Trade/Device Name: Dimension® Automated HDL Cholesterol (AHDL) Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein test system Regulatory Class: Class I Product Code: LBS Dated: November 11, 2005 Received: November 14, 2005

Dear Mr. Carrio:

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) I ins icticle will anow you to ough mailing of substantial equivalence of your device to a legally prematics notification: "The PDs in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or you desire specific introlion and advertising of your device, please contact the Office of In of questions on the promotion and Safety at [phone]. Also, please note the v fire Diagnounding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the r ou may obtain other general ers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Alberto G. A.

Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications For Use Statement

510(k) Number: K053157

Device Name(s):

Dimension® Automated HDL Cholesterol (AHDL) Flex® reagent cartridge (DF48A)

Indications for Use:

The AHDL method for the Dimension® clinical chemistry system is an in vitro The ATIDE motive ded to quantitatively measure high density lipoprotein cholesterol (HDL-C) in human serum and plasma. HDL-C measurements are used as an aid in the diagnostics of lipid disorders.

X Prescription Use_ (Per 21 CFR 801 Subpart D)

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OR

Over-the-counter Use (21CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol Benson
Director

Omice of In Vitro Diagnostin Device Evaluation und Safabr

K053,57