DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B

K073072 · Dade Behring, Inc. · JHM · Feb 21, 2008 · Clinical Chemistry

Device Facts

• Record ID: K073072
• Device Name: DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B
• Applicant: Dade Behring, Inc.
• Product Code: JHM · Clinical Chemistry
• Decision Date: Feb 21, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1475
• Device Class: Class 1

Intended Use

The AHDL method is an in vitro diagnostic test for the quantitative measurement of high-density lipoprotein cholesterol (HDL-C) in human serum and plasma on the Dimension® clinical chemistry system. Measurements of HDL-C are used as an aid in the diagnosis of lipid disorders (such as diabetes mellitus), various liver and renal diseases and in the assessment of risk for atherosclerosis and cardiovascular disease.

Device Story

AHDL Flex reagent cartridge performs in vitro diagnostic measurement of HDL-C in human serum/plasma. Device uses two-reagent format; first reaction uses dextran sulfate/magnesium sulfate to form water-soluble complexes with chylomicrons, VLDL, and LDL, rendering them resistant to cholesterol esterase and oxidase. HDL cholesterol is oxidized to 24-cholestenone and hydrogen peroxide; peroxide reacts with 4-aminoantipyrine and HSDA via peroxidase to form colored dye. Color intensity measured via bichromatic (600/700 nm) endpoint technique on Dimension clinical chemistry system. Intensity proportional to serum HDL-C concentration. Used in clinical laboratory settings by trained personnel. Output provides quantitative HDL-C levels to assist clinicians in diagnosing lipid disorders and assessing cardiovascular risk.

Clinical Evidence

Bench testing only. Performance evaluated per CLSI guidelines (EP05-A2, EP07-A2, EP09-A2, EP17-A). Precision: %CV 1.4-2.4%. Linearity: 3-150 mg/dL. Limit of Detection: 3 mg/dL. Method comparison (n=134) vs. predicate showed slope 1.04, intercept -3.9, r=1.00. Matrix comparison (serum vs. heparin plasma) showed high correlation (r=1.00). No clinical studies performed.

Technological Characteristics

Quantitative colorimetric assay. Reagents: HEPES buffer, 2-(N-cyclohexylamino)-ethanesulfonic acid, PEG-modified cholesterol esterase, cholesterol oxidase, peroxidase, 4-aminoantipyrine, HSDA. Measurement: Bichromatic (600/700nm) endpoint. System: Dimension clinical chemistry analyzer. Traceability: CRMLN certified.

Indications for Use

Indicated for quantitative measurement of HDL-C in human serum and plasma to aid in diagnosis of lipid disorders (e.g., diabetes mellitus), liver/renal diseases, and assessment of atherosclerosis/cardiovascular disease risk.

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® AHDL Flex® reagent cartridge (k032798)

Submission Summary (Full Text)

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## FEB 21 201

### 510(k) Summary

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

The assigned 510(k) number is:

073072

### 1. Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation

Manufacturer:

Contact Information:

Dade Behring Inc. P.O. Box 6101 Newark, DE 19714

Dade Behring Inc. P.O. Box 6101 Newark, DE 19714 Attn: Pamela A. Jurga Tel: [phone]

Date of Preparation:

October 30, 2007

#### 2. Device Name / Classification

- . Dimension® AHDL Flex® reagent cartridge/ Class I
#### 3. Identification of the Predicate Device

- Dimension® AHDL Flex® reagent cartridge (K032798) .
## FDA Guidance Document(s):

- "Guidance on Informed Consent for In Vitro Diagnostic Device Studies . Using Leftover Human Specimens that are Not Individually Identifiable -Guidance for Sponsors, Institutional Review Boards, Clinical Investigators and FDA Staff "- 4/25/2006
#### 4. Device Description(s):

The AHDL assay measures HDL cholesterol levels directly without the need for sample pretreatment or specialized centrification steps, using a two reagent format. In the first reaction, chylpmicrons, VLDL and LDL form water soluble complexes with dextran sulfate in the presence of magnesium sulfate. These complexes are resistant to the polyethylene glycol (PEG)-modified cholesteril esterse

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Dade Behring Inc. Dimension® AHDL Method 510(k) Premarket Notification

and cholesterol oxidase that react with HDL cholesterol. In the presence of oxygen, the HDL cholesterol is oxidized to 24-cholestenone and hydrogen peroxide. The generated hydrogen peroxide then reacts with 4-aminoantipyrine and sodium N-(2-hydroxy-3-sulfopropyl)-3,5-dimethoxyaniline (HSDA) in the presence of peroxidase to form a colored dye that is measured using a bichromatic (600/700 nm) endpoint technique. The color intensity of the dye is directly proportional to the serum HDL-C concentration.

#### 5. Device Intended Use:

The AHDL method is an in vitro diagnostic test for the quantitative measurement of high-density lipoprotein cholesterol (HDL-C) in human serum and plasma on the Dimension® clinical chemistry system. Measurements of HDL-C are used as an aid in the diagnosis of lipid disorders (such as diabetes mellitus), various liver and renal diseases and in the assessment of risk for atherosclerosis and cardiovascular disease.

#### 6. Medical device to which equivalence is claimed:

### Substantial Equivalence:

This product is substantially equivalent to other HDL test systems, such as the Dimension® AHDL Flex® reagent cartridge (K032798).

### Comparison to Predicate Device:

The proposed Dade Behring Dimension AHDL method and the predicate Dimension® AHDL method are both in vitro diagnostic assays intended for the quantitative measurement of high-density lipoprotein cholesterol (HDL-C) in human serum and plasma on the Dimension® clinical chemistry system.

A comparison summary of the features of the products is included in the following table.

### Method:

| Item | Device | Predicate |
|--------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The AHDL method is an <i>in vitro</i> diagnostic test for the quantitative measurement of high-density lipoprotein cholesterol (HDL-C) in human serum and plasma on the Dimension® clinical chemistry system. Measurements of HDL-C are used as an aid in the diagnosis of lipid disorders (such as diabetes mellitus), various liver and renal diseases and in the assessment of risk for atherosclerosis and cardiovascular disease. | The AHDL method for the Dimension® clinical chemistry system is an <i>in vitro</i> diagnostic test intended to quantitatively measure high-density lipoprotein cholesterol (HDL-C) in human serum and plasma. HDL-C measurements are used as an aid in the diagnosis of lipid disorders |

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| Sample Type | Human Serum or Plasma | Human Serum or Plasma |
|-----------------------|--------------------------------------|------------------------------------------------|
| Sample Size | 3 uL | 3 uL |
| Measurement<br>method | PEG HDL-C (polyethylene<br>modified) | Accelerator Selective Detergent<br>Methodology |
| Measuring Range | 3-150 mg/dL | 3-150 mg/dL |

### Comments on Substantial Equivalence:

The proposed Dade Behring Dimension AHDL method (DF48B) and the predicate Dimension® AHDL method (DF48A) are both in vitro diagnostic assays intended for the quantitative measurement of high-density lipoprotein cholesterol (HDL-C) in human serum and plasma on the Dimension® clinical chemistry system.

Method comparison testing with human serum samples following CLSI Approved Guideline for Method Comparison and Bias Estimation Using Patient Samples; EP9-A2 demonstrates good analytical and clinical agreement between the methods giving the following linear regression statistics:

| Comparative Method | Slope | Intercept<br>mg/dL | Correlation<br>Coefficient | n |
|------------------------|-------|--------------------|----------------------------|-----|
| Dimension AHDL (DF48A) | 1.04 | -3.9 | 1.00 | 130 |

### Conclusion:

The proposed Dade Behring Dimension AHDL method (DF48B)and the predicate Dimension® AHDL method (DF48A) (K032798) are substantially equivalent based on their intended use and performance characteristics as described above.

Amella

Pamela A. Jurga Regulatory Affairs and Compliance Manager October 30, 2007

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the wings and body.

Public Health Service

FEB 21 2008

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Dade Behring, Inc. Glasgow Business Community c/o Ms. Pamela A. Jurga Regulatory Affairs and Compliance Manager P.O. Box 6101, Bldg. 500, M/S 514 Newark, DE 19714-6101

Re: k073072

> Trade/Device Name: Dimension® AHDL Flex® Reagent Cartridge Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein test system. Regulatory Class: Class I, meets the limitation to exemption in 862.9(c)(4) Product Code: JHM Dated: January 25, 2008 Received: January 28, 2008

Dear Ms. Jurga:

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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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to 10gally marketed predicate device results in a classification for your device and thus, perceits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from to r Division of Small Manufacturers, International and Consumer Assistance at its toll free mumber [phone] or [phone] or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Yean M. Cooper, M.S., D.V.M. 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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Dade Behring Inc. Dimension® AHDL Method 510(k) Premarket Notification

# Indications for Use

510(k) Number (if known): k 0 7 3072

Indications For Use:

The AHDL method is an in vitro diagnostic test for the quantitative measurement of high-density lipoprotein cholesterol (HDL-C) in human serum and plasma on the Dimension® clinical chemistry system. Measurements of HDL-C are used as an aid in the diagnosis of lipid disorders (such as diabetes mellitus), various liver and renal diseases and in the assessment of risk for atherosclerosis and cardiovascular disease.

Prescription Use ﮨﮯ (Per 21 CFR 801 Subpart D) AND/OR

Over-the-counter Use (21 CFR 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)

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Dean Cooper, D.V.M.
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safet

073072