DIMENSION AUTOMATED HIGH DENSITY LIPOPROTEIN CHOLESTEROL (ADHL) FLEX REAGENT CARTRIDGE

K983849 · Dade Behring, Inc. · JHM · Jan 11, 1999 · Clinical Chemistry

Device Facts

• Record ID: K983849
• Device Name: DIMENSION AUTOMATED HIGH DENSITY LIPOPROTEIN CHOLESTEROL (ADHL) FLEX REAGENT CARTRIDGE
• Applicant: Dade Behring, Inc.
• Product Code: JHM · Clinical Chemistry
• Decision Date: Jan 11, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1475
• Device Class: Class 1

Intended Use

The AHDL method for the Dimension® clinical chemistry system is a device used to quantitatively measure High Density Lipoprotein Cholesterol in human serum or plasma. AHDL measurements may be used in the diagnosis and treatment of lipid disorders.

Device Story

Dimension® AHDL Flex™ reagent cartridge is an in vitro diagnostic assay for the Dimension® clinical chemistry system. It performs direct, homogeneous measurement of HDL cholesterol in human serum or plasma without off-line pretreatment or centrifugation. The device uses a two-reagent format containing a unique detergent and polyanion; the detergent selectively solubilizes HDL particles while inhibiting reactions with LDL, VLDL, and chylomicrons. The polyanion assists in complexing non-HDL particles to enhance selectivity. The system measures the resulting color development via enzymatic colorimetric bichromatic endpoint detection. Used in clinical laboratories by trained personnel, the output provides quantitative HDL cholesterol levels. This information assists healthcare providers in diagnosing and managing lipid disorders, offering a more efficient workflow compared to manual precipitation methods by eliminating centrifugation and reducing sample volume requirements.

Clinical Evidence

Bench testing and clinical comparison performed. Split-sample comparison between the Dimension® AHDL method and the predicate Dimension® HDL assay conducted using 272 clinical patient samples with concentrations ranging from 9-105 mg/dL. Results demonstrated a correlation coefficient of 0.991, a slope of 0.931, and an intercept of 0.811 mg/dL.

Technological Characteristics

Direct homogeneous enzymatic colorimetric assay. Reagents include a unique detergent for selective HDL solubilization and a polyanion for complexing LDL, VLDL, and chylomicrons. Detection via bichromatic endpoint. Requires 3 µL sample volume. Designed for use on the Dimension® clinical chemistry system. No specific materials of construction or software algorithm class details provided beyond standard clinical chemistry instrumentation.

Indications for Use

Indicated for quantitative measurement of High Density Lipoprotein (HDL) cholesterol in human serum or plasma to aid in the diagnosis and treatment 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.

Predicate Devices

• Dimension® High Density Lipoprotein Cholesterol (HDL) Assay

Submission Summary (Full Text)

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### JAN 1 1 1999

# DADE BEHRING

DADE BEHRING INC. P.O. Box 6101 Newark, DE 19714

Submitter's Name:

#### Summary of Safety and Effectiveness Information

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

> Rebecca S. Ayash Dade Behring Inc. Building 500. Mailbox 514 P.O. Box 6101 Newark, DE 19714-6101

Date of Preparation: 10/29/98

Device Name: Dimension® Automated High Density Lipoprotein Cholesterol (AHDL) Flex™ reagent cartridge

Classification Name: Colorimetric Method, Lipoprotein

Predicate Device: Dimension® High Density Lipoprotein Cholesterol (HDL) Assay

Device Description: The AHDL method for the Dimension® clinical chemistry system is a homogeneous method for direct measurement of high density lipoprotein (HDL) cholesterol levels without the need for off-line pretreatment or centrifugation steps.

The method is in a two-reagent format and depends on the properties of a unique detergent, which solubilizes only the HDL particles, thus releasing HDL cholesterol to react with cholesterol esterase to produce color. In addition to selectively disrupting the HDL particles, this detergent also inhibits the reaction of the cholesterol enzymes with LDL, VLDL and chylomicrons by adsorbing to their surfaces. A polyanion is contained in the first reagent to assist with complexing LDL, VLDL and chylomicrons, further enhancing the selectivity of the detergent and enzymes for HDL cholesterol.

Image /page/0/Figure/13 description: This image shows a series of chemical reactions. LDL, VLDL, and Chylomicrons react with detergent and polyanion to form stable complexes. HDL reacts with detergent to become disrupted. HDL Cholesterol reacts with Cholesterol esterase and Cholesterol oxidase to form Δ' Cholestenone + H₂O₂, and H₂O₂ + DSBmT + 4AA reacts with Peroxidase to produce color development.

DSBmT = N.N-bis(4-sulphobuty)) m-toluidine-disodium

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Intended Use: The AHDL method for the Dimension® clinical chemistry system is a device used to quantitatively measure High Density Lipoprotein Cholesterol in human serum or plasma. AHDL measurements may be used in the diagnosis and treatment of lipid disorders.

#### Comparison to Predicate Device:

| Item | Dimension® AHDL Method | Dimension® HDL Method |
|--------------|----------------------------------------------------------------|----------------------------------------------------------------|
| Technology | Direct homogeneous | Manual phosphotungsate<br>precipitation |
| Detection | Enzymatic colorimetric<br>bichromatic endpoint | Enzymatic colorimetric<br>polychromatic endpoint |
| Separation | Polyanions, detergent | Centrifugation |
| Sample Size | 3 µL | 250 µL |
| Sample Type | serum or plasma | serum or plasma |
| Intended Use | For the measurement of high<br>density lipoprotein cholesterol | For the measurement of high<br>density lipoprotein cholesterol |

Comments on Substantial Equivalence: Split sample comparison between the Dimension® AHDL method and the Dimension® HDL assay gave a correlation coefficient of 0.991, slope of 0.931, and an intercept of 0.811 mg /dL when tested with 272 clinical patient samples ranging from 9 - 105 mg/dL.

Conclusion: The AHDL Method for the Dimension® clinical chemistry system is substantially equivalent in principle and performance to the Dimension® HDL method based on the split sample comparison summarized above.

Rebecca S. Ayash

Rebecca S. Avas Regulatory Affairs and Compliance Manager Date: 10/29/98

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol.

Public Health Service

JAN 1 1 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Rebecca S. Ayash Regulatory Affairs and Compliance Manager Dade Behring, Inc. Glasgow Building 500 Mail Box 514 P.O. box 6101 Newark, DE 19714

Re: K983849

> Trade Name: Dimension Automated High Density Lipoprotein Cholesterol Flex™ reagent cartridge

Regulatory Class: I Product Code: JHM Dated: October 29, 1998 Received: October 30, 1998

Dear Ms. Ayash:

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 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 regulation (21 CFR Part 820) and that, through periodic OS 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 at [phone] or at its internet address "http://www.fda.gov/cdrh/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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## Indications Statement

Device Name: Dimension® Automated High Density Lipoprotein Cholesterol (AHDL) Flex™ reagent cartridge

Indications for Use: The AHDL method for the Dimension® clinical chemistry system is a device used to quantitatively measure High Density Lipoprotein Cholesterol in human serum or plasma. AHDL measurements are used as an aid in the diagnosis and treatment of lipid disorders.

Rebecca S. Ayish

Rebecca S. Avash & Regulatory Affairs and Compliance Manager Date: 10/29/98

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

K983849
510(k) Number

Patricio Benlert
Division Sign Off by M. Alfred Mortson

err Dr. Co. Division Sign-Off Office of Device Evaluation

prescription use

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