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 Description

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 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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Dade Behring Dimension® AHDL Method:

This document is a 510(k) summary for a new version of an in vitro diagnostic (IVD) device, specifically a reagent cartridge for measuring HDL cholesterol. The study presented here is a method comparison study to demonstrate that the new device (DF48B) is substantially equivalent to a previously cleared predicate device (DF48A).

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a traditional table format with pass/fail thresholds. Instead, it demonstrates substantial equivalence through a direct comparison with a predicate device and reports statistical measures of agreement.

Performance Metric	Acceptance Criteria (Implied by Substantial Equivalence Goal)	Reported Device Performance (New Device DF48B vs. Predicate DF48A)
Slope	Close to 1.00	1.04
Intercept	Close to 0 mg/dL	-3.9 mg/dL
Correlation Coefficient	Close to 1.00 (indicating strong linear correlation)	1.00
Intended Use	Identical to Predicate Device	Identical
Sample Type	Identical to Predicate Device	Identical (Human Serum or Plasma)
Sample Size	Identical to Predicate Device	Identical (3 uL)
Measuring Range	Identical to Predicate Device	Identical (3-150 mg/dL)

Note: The "acceptance criteria" are implied by the goal of demonstrating substantial equivalence to the predicate device. The reported performance metrics (slope, intercept, correlation coefficient) are used to support this claim, showing "good analytical and clinical agreement."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: 130 human serum samples.
Data Provenance: The data provenance is not explicitly stated regarding country of origin. It is a retrospective study using human serum samples. The statement "using Leftover Human Specimens that are Not Individually Identifiable" from the cited FDA guidance document suggests these samples were collected previously and then used for this study.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This type of study (method comparison for an in vitro diagnostic device) does not typically involve "experts" establishing a ground truth in the way one might for an imaging or clinical diagnosis device.
Instead, the "ground truth" for this study is implicitly the measurement obtained by the predicate device (Dimension® AHDL method, DF48A), as the goal is to show agreement of the new device (DF48B) with the established predicate. There are no external experts adjudicating the results of the predicate device.

4. Adjudication Method for the Test Set

No adjudication method is described, as it is not applicable to this type of chemical assay comparison study. The comparison is between two quantitative measurement methods.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices (e.g., imaging devices) where human readers interpret results, and the AI's impact on human performance is assessed. This document describes a chemical assay, so human reader involvement in the measurement itself (beyond operating the instrument) is not a relevant factor.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone performance study was inherently done. This is a standalone performance study of the device (reagent cartridge on a clinical chemistry system). The algorithm in this context refers to the chemical reaction and measurement method rather than a software algorithm making diagnostic decisions. The "performance" being evaluated is the analytical agreement of the new reagent cartridge with the predicate reagent cartridge in measuring HDL-C.

7. Type of Ground Truth Used

The "ground truth" used for this method comparison study is the quantitative measurement of HDL-C obtained from the predicate device (Dimension® AHDL method, DF48A) for the same 130 human serum samples. The study aims to demonstrate that the new device's readings are in close agreement with the predicate's readings. It is not pathology, outcomes data, or expert consensus in the typical sense.

8. Sample Size for the Training Set

The document does not mention a training set. This is expected for an in vitro diagnostic (IVD) reagent cartridge. Unlike machine learning algorithms that require training data, these chemical assays are developed and validated based on their chemical properties and analytical performance without a "training" phase on patient data.

9. How the Ground Truth for the Training Set Was Established

As there is no mention of a training set, the establishment of ground truth for a training set is not applicable.

Summary

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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: 302-631-8891

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):

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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:

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 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.	The AHDL method for the Dimension® clinical chemistry system is an in vitro 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
Measurementmethod	PEG HDL-C (polyethylenemodified)	Accelerator Selective DetergentMethodology
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	Interceptmg/dL	CorrelationCoefficient	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 (240) 276-0490. 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 (800) 638-2041 or (240) 276-3150 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:

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)

Page 1 of 1

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

Office of In Vitro Diagnostic Device Evaluation and Safet

073072

Regulation Number and Section

§ 862.1475 Lipoprotein test system.

(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.