DIMENSION AUTOMATED LDL CHOLESTEROL FLEX REAGENTCARTRIDGE METHOD, MODEL DF131

K020724 · Dade Behring, Inc. · MRR · May 9, 2002 · Clinical Chemistry

Device Facts

• Record ID: K020724
• Device Name: DIMENSION AUTOMATED LDL CHOLESTEROL FLEX REAGENTCARTRIDGE METHOD, MODEL DF131
• Applicant: Dade Behring, Inc.
• Product Code: MRR · Clinical Chemistry
• Decision Date: May 9, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1475
• Device Class: Class 1

Intended Use

The Dade Behring Dimension® Automated LDL Cholesterol Flex® reagent cartridge method is an in vitro diagnostic test intended for the quantitative determination of lowdensity lipoprotein cholesterol in human serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders and various liver and renal diseases.

Device Story

In vitro diagnostic test for quantitative measurement of LDL cholesterol in human serum or plasma. Uses prepackaged flexible plastic reagent cartridges on Dimension® clinical chemistry systems. Principle: homogeneous two-reagent enzymatic method. Detergent 1 solubilizes non-LDL particles; cholesterol esterase/oxidase consume cholesterol in non-color forming reaction. Detergent 2 solubilizes LDL particles; cholesterol esterase/oxidase convert LDL-C to cholestenone and hydrogen peroxide. Peroxidase reacts with H2O2, DSBmT, and 4-aminoantipyrine to produce color measured via bichromatic endpoint (540 nm, 700 nm). Used in clinical laboratories by technicians/physicians. Output is LDL-C concentration. Assists clinicians in diagnosing/treating lipid disorders, liver, and renal diseases.

Clinical Evidence

Comparative performance studies conducted against Genzyme N-geneous™ LDL-Cholesterol assay (n=122) and CRMLN Beta-Quantification reference method (n=49). Results: Correlation coefficient 0.997 (vs Genzyme) and 0.982 (vs Beta-Quantification). Slope 0.95 and 1.01 respectively. Bench testing only.

Technological Characteristics

In vitro diagnostic reagent cartridge. Two-reagent enzymatic assay. Principle: Detergent-based selective solubilization followed by peroxidase-coupled colorimetric endpoint detection. Bichromatic measurement at 540 nm and 700 nm. Designed for use on Dimension® clinical chemistry systems.

Indications for Use

Indicated for the quantitative determination of LDL cholesterol in human serum and plasma for the diagnosis and treatment of lipid disorders and various liver and renal diseases.

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

• Genzyme N-geneous™ LDL-Cholesterol assay (K971573)

Reference Devices

• Beta-Quantification reference method (CRMLN)

Submission Summary (Full Text)

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K020724

### 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.

| Submitter's Name: | Richard M. Vaught<br>Dade Behring Inc.<br>P.O. Box 6101<br>Newark, DE 19714-6101 |
|----------------------|----------------------------------------------------------------------------------|
| Date of Preparation: | March 5, 2002 |
| Name of Product: | Dade Behring Dimension® Automated LDL Cholesterol |

FDA Classification Name: Lipoprotein test system

Predicate Device: The Genzyme N-geneous™ LDL-Cholesterol assay (K971573) and the Beta-Quantification reference method utilized by the Cholesterol Reference Method Laboratory Network (CRMLN).

Flex® reagent cartridge method

Device Description: The Dade Behring Dimension® Automated LDL Cholesterol Flex® reagent cartridge method is an in vitro diagnostic test that consists of prepackaged reagents in a flexible plastic cartridge for use on the Dimension® clinical chemistry system. The Dimension® Automated LDL Cholesterol Flex® reagent cartridge assay is a homogeneous method for directly measuring low-density lipoprotein cholesterol in human serum or plasma without the need for off-line pretreatment or centrifugation steps.

The method is in a two reagent format and depends on the properties of detergent 1 which solubilizes only non- LDL particles. The cholesterol released is consumed by cholesterol esterase and cholesterol oxidase in a non-color forming reaction. Detergent 2 solubilizes the remaining LDL particles. The soluble LDL-C is then oxidized by the action of cholesterol esterase and cholesterol oxidase forming cholestenone and hydrogen peroxide

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(H2O2). The enzymatic action of peroxidase on H2O2 produces color in the presence of (11507). The Chilymatio action of Pe, disodium salt (DSBmT) and 4-aminoantipyrine (4-N,N-015(++Suffooury) in continer, around (540 nm, 700 nm) endpoint technique. The AA) that is measured as as a cremoral to the amount of LDL-C present in the sample.

Image /page/1/Figure/1 description: This image shows a series of chemical reactions. In the first reaction, nonsoluble LDL-C, VLDL-C, HDL-C, and Chylomicrons are converted to soluble Non-LDL-C, (VLDL-C, HDL-C, Chylomicrons) using Detergent 1. Soluble Non-LDL-C is converted to a non-color forming product using Cholesterol esterase and Cholesterol oxidase. In another reaction, nonsoluble LDL-C is converted to soluble LDL-C using Detergent 2, and soluble LDL-C + O2 is converted to Cholestenone + H2O2 using Cholesterol esterase and Cholesterol oxidase. Finally, H2O2 + DSBmT + 4-AA is converted to a color development product using Peroxidase.

Intended Use: The Dimension® Automated LDL Cholesterol Flex® reagent cartridge method is an in vitro diagnostic test intended for the quantitative determination of lowdensity lipoprotein cholesterol in human serum and plasma.

Comparison to Predicate Device: A summary of features for the Dimension® Automated LDL Cholesterol Flex® reagent cartridge method and the predicate device, the Genzyme N-geneous™ LDL Cholesterol reagent set (K971573) as utilized on automated analyzers are provided in the following chart:

| | Dade Behring Dimension® Automated<br>LDL Cholesterol Flex® reagent method | Genzyme N-geneous™ LDL Cholesterol<br>assay (for use on automated analyzers) |
|--------------|---------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Intended Use | in vitro use | in vitro use |
| Sample size | 3 uL | 3 uL |
| Measurement | Direct LDL determination;<br>Bichromatic endpoint;<br>540 nm and 700nm | Direct LDL determination;<br>Bichromatic endpoint;<br>546 nm and 660 nm |
| Reagents | Two-detergent Genzyme N-geneous™<br>LDL Cholesterol reagent set | Two-detergent Genzyme N-geneous™<br>LDL Cholesterol reagent set |

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Additionally, comparative performance studies were conducted between the Dimension® Automated LDL Cholesterol Flex® reagent cartridge method and both the Genzyme Ngeneous™ LDL Cholesterol assay (on the Beckman CX-9 automated analyzer) and the CRMLN Beta-Quantification reference method. The results are summarized below:

| Comparative<br>Method | Slope | Intercept<br>(mg/dL) [mmol/L] | Correlation<br>Coefficient | n |
|---------------------------------------------|-------|-------------------------------|----------------------------|-----|
| Genzyme N-geneous™ LDL<br>Cholesterol assay | 0.95 | 4.7 [0.12] | 0.997 | 122 |
| Beta-Quantification method | 1.01 | 3.3 [0.08] | 0.982 | 49 |

Comments on Substantial Equivalence: The Dimension® Automated LDL Cholesterol Flex® reagent cartridge method has the same intended use, employs the same design, and utililzes the same reagent set as the predicate device, the Genzyme N-geneous™ LDL Cholesterol reagent set (K971573).

Conclusion: The Dimension® Automated LDL Cholesterol Flex® reagent cartridge method is substantially equivalent in design and performance to both the Genzyme Ngeneous LDL Cholesterol assay and the CRMLN Beta-Quantification reference method based on the comparison studies as described above.

Richard M. Hodes

Richard M. Vaught Regulatory Affairs and Compliance Manager March 5, 2002

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding it.

MAY 0 9 2002

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Richard M. Vaught Regulatory Affairs and Compliance Manager Dade Behring Inc. Chemistry/Immunochemistry Glasgow Business Community Bldg. 500, M. S. 514 P.O. Box 6101 Newark, DE 19714-6101

k020724 Re:

Trade/Device Name: Dimension® Automated LDL Cholesterol Flex® Reagent Cartridge Method Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein test system Regulatory Class: Class I, reserved Product Code: MRR Dated: March 5, 2002 Received: March 6, 2002

Dear Mr. Vaught:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set

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Page 2 -

This letter will allow you to begin marketing your device as described in your 510(k) premarket I his leation. 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 1 II you dostre specific an in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, (1 sase contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrl/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

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 For Use Statement

K020724

#### Device Name:

Dimension® Automated LDL Cholesterol Flex® reagent cartridge method

#### Indications for Use:

The Dade Behring Dimension® Automated LDL Cholesterol Flex® reagent The Dado Don'ting Diniensitro diagnostic test intended for the quantitative cartings method is an in This Catagratein cholesterol in human serum and plasma. determination of 10% cents are used in the diagnosis and treatment of lipid Lipoprotem measurements are uses a and various liver and various liver and renal diseases.

Rem Vaught
Richard M. Vaught

Regulatory Affairs and Compliance Manager

March 5, 2002

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

## Concurrence of CDRH, Office of Device Evaluation (ODE)

Cooper
(Division Sign-Off)
Division of Ciucal Laboratory Devices
510(k) Numbe: K020774

Prescription Use (Per 21 CFR 801.109)

OR

Over-the-counter Use

(Optional format 1-2-96)