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.

Device Description

The Dimension® Automated HDL Cholesterol (AHDL) Flex® reagent cartridge (DF48A) is an in vitro diagnostic device that consists of prepackaged reagents in a plastic cartridge (Flex®) for use on the Dade Behring Dimension® clinical chemistry system.

AI/ML Overview

This document describes a 510(k) premarket notification for a revised in vitro diagnostic device, the Dimension® Automated HDL Cholesterol (AHDL) Flex® reagent cartridge (DF48A). The purpose of the submission is to demonstrate substantial equivalence to a predicate device, the Dimension® Automated HDL Cholesterol (AHDL) Flex® reagent cartridge (DF48).

Here's an analysis of the provided information, framed by your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (in vitro diagnostic for quantitative measurement), acceptance criteria are typically related to the correlation and agreement with a predicate device. The performance is demonstrated through a split-sample comparison study.

Acceptance Criteria (Implied)	Reported Device Performance
Strong linear correlation (e.g., correlation coefficient close to 1) between the revised device and the predicate device.	Correlation Coefficient: 0.995
Acceptable agreement in slope (close to 1) and intercept (close to 0) between the revised device and the predicate device.	Slope: 1.04Intercept: -3.38 mg/dL [-0.09 mmol/L]

Note: The document explicitly states "Comments on Substantial Equivalence" and presents these statistical parameters. While explicit 'acceptance criteria' values (e.g., "correlation coefficient > 0.98") are not formally listed, these statistical measures infer the criteria for demonstrating substantial equivalence.

2. Sample Size for the Test Set and Data Provenance

Sample Size (Test Set)	Data Provenance
101 samples	Clinical patient samples (retrospective/prospective not specified, but typically retrospective for method comparison studies)

Note: The country of origin for the data is not specified in the provided text.

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

This information is not applicable and not provided in the document.

For in vitro diagnostic devices measuring a quantitative analyte like HDL Cholesterol, the "ground truth" for method comparison is typically the result obtained from a legally marketed and accepted predicate device or a reference method, not an expert panel.
The study compares the new device (DF48A) to an existing, legally marketed predicate device (DF48). The predicate device's results are considered the benchmark for comparison, not a consensus of human experts.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the document. As explained above, this study is a quantitative method comparison, not one that requires adjudication by experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not applicable and not provided in the document.

MRMC studies are typically performed for diagnostic imaging devices where human readers interpret images, sometimes with AI assistance.
This device is an automated in vitro diagnostic test for a chemical analyte (HDL-C) and does not involve human interpretation of cases or a "human-in-the-loop" application in the way an imaging device would.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, this study represents a standalone performance evaluation of the device.

The device is an "Automated HDL Cholesterol (AHDL) Flex® reagent cartridge." It is designed to quantitatively measure HDL-C in human serum and plasma directly.
The comparison study evaluates the performance of this automated system directly against the predicate automated system, without any human interpretation or intervention in the measurement process itself.

7. Type of Ground Truth Used

The "ground truth" (or reference standard) for this study is the results obtained from the predicate device, the "Current" Dimension® Automated HDL Cholesterol Flex® reagent cartridge (DF48). This is a common approach for demonstrating substantial equivalence of a new in vitro diagnostic device to an already cleared one.

8. Sample Size for the Training Set

This information is not provided and likely not applicable in the context of this device.

The Dimension® Automated HDL Cholesterol (AHDL) Flex® reagent cartridge is an in vitro diagnostic device composed of prepackaged reagents that use an "Enzymatic Colormetric Bichromatic Endpoint" detection method. These methods are based on established chemical reactions and principles.
There's no indication that this device uses machine learning or AI models that would require a "training set" in the conventional sense (e.g., for pattern recognition or classification). The development would involve chemical optimization and calibration, not machine learning model training.

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

This information is not applicable as there is no indication of a "training set" in the context of machine learning for this device.

Summary

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OCT 3 0 2003

"revised" Dimension® Automated HDLCholesterol (AHDL) Flex® reagent cartridge (DF48A)

510(k) Summary

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.

The assigned 510(k) number is :	67 7 799. 18

Submitter's Name

Andrea M. Tasker Dade Behring Inc. Building 500, Mailbox 514 P.O.Box 6101 Newark, DE 19714-6101

Submission Preparation Date:

September 8, 2003

Device Name and Classification

Trade Name:	Dimension® Automated HDL Cholesterol(AHDL)
	Flex® reagent cartridge
Common/Usual Name:	Colorimetric Method, Lipoprotein
Classification:	Class I
Product Code:	JHM

Predicate Device

Dimension® Automated HDL Cholesterol (AHDL) Flex® reagent cartridge (DF48) FDA Document Control No. K983849

Device Description

Intended Use

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Comparison to Predicate Device

	"Current" Dimension®Automated HDL CholesterolFlex® reagent cartridge (DF48)	"Revised" Dimension®Automated HDL CholesterolFlex® reagent cartridge (DF48A)
Intended Use	For the measurement of highdensity lipoprotein cholesterol	For the measurement of highdensity lipoprotein cholesterol
Sample Type	Human Serum or Plasma	Human Serum or Plasma
Sample Volume	3uL	3uL
Detection	Enzymatic ColormetricBichromatic Endpoint	Enzymatic ColormetricBichromatic Endpoint
Wavelengths	600 and 700 nm	600 and 700nm
Reagent 1 Vol.	300uL	300uL
Reagent 2 Vol.	100uL	100uL
Methodology	Polyanion SelectiveDetergent Methodology	Accelerator SelectiveDetergent Methodology

Comments on Substantial Equivalence

Split sample comparison between the "current" Dimension® Automated HDL Cholesterol (AHDL) Flex® reagent cartridge (DF48) and the "revised" Dimension® Automated HDL Cholesterol (AHDL) Flex® reagent cartridge (DF48A) gave the following correlation statistics, when tested with clinical patient samples.

Revised AHDL (DF48A)		Intercept	Correlation
VS.	Slope	mg/dL [mmol/L]	Coefficient	n
Current AHDL (DF48)	1.04	-3.38 [-0.09]	0.995	101

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Conclusion

The results of performance studies demonstrate that the "revised" Dimension® Automated HDL Cholesterol (AHDL) Flex® reagent cartridge (DF48A) is substantially equivalent to the Dimension® Automated HDL Cholesterol (AHDL) Flex® reagent cartridge (DF48) FDA Document Control No. K983849 .

Rua m. Ture

Andrea M. Tasker Senior Regulatory Affairs and Compliance Specialist Date: September 8, 2003

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Andrea M. Tasker Senior Regulatory Affairs and Compliance Specialist Dade Behring, Inc. Chemistry/Immunochemistry Glasgow Business Community Bldg. 500 - P.O. Box 6101 Newark, DE 19714

OCT 3 0 2003

Re: K032798

Trade/Device Name: Dimension® Automated HDL Cholesterol (AHDL) Flex® reagent cartridge (DF48A) Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein test system Regulatory Class: Class I Product Code: JHM Dated: September 8, 2003 Received: September 9, 2003

Dear Ms. Tasker:

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) 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 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 (301) 594-3084. 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 the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Putman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications For Use Statement

K032798

Device Name:

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

Indications for Use:

Qun n. Tan

Andrea M. Tasker Senior Regulatory Affairs and Compliance Specialist

September 8, 2003

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	X
(Per 21 CFR 801.109)
OR
Over-the-counter Use
(Optional format 1-2-96)
Carol C Benson for Jean Cooper, DVM
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

210(k)

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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.