The Direct HDL assay is used for the quantitation of high-density lipoprotein cholesterol levels in human serum or plasma. Low Direct HDL measurements are used in the diagnosis and treatment of coronary artery disease.

Device Description

Direct HDL is an in vitro diagnostic assay for the quantitative determination of high-density lipoprotein cholesterol in serum or plasma. The Direct HDL assay is a two reagent format and depends on the properties of a unique detergent. This detergent solubilizes only the HDL lipoprotein particles, thus releasing the HDL cholesterol to react with cholesterol esterase and cholesterol oxidase, in the presence of chromogens to produce color. In addition to selectively disrupting the HDL lipoprotein particles, this unique detergent also inhibits the reaction of the cholesterol enzymes with LDL, VLDL, and chylomicron lipoproteins by adsorbing to their surfaces. A polyanion is contained in the first reagent to assist with complexing LDL, VLDL, and chylomicron lipoproteins, further enhancing the selectivity of the detergent and enzymes for HDL cholesterol.

AI/ML Overview

This 510(k) submission describes the Direct HDL assay, an in vitro diagnostic assay for the quantitative determination of high-density lipoprotein cholesterol in serum or plasma.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Method Comparison	Acceptable correlation with Boehringer Mannheim Direct HDL assay on Hitachi 717 Analyzer. (Specific R, Slope, Y-intercept values are not explicitly stated as acceptance criteria but are the values reported as meeting "acceptable correlation").	Correlation coefficient = 0.9882Slope = 1.067Y-intercept = 0.372 mg/dL. These data demonstrate that the performance of the Direct HDL assay is substantially equivalent to the performance of the Boehringer Mannheim Direct HDL assay on the Hitachi 717 Analyzer.
Precision	Acceptable within-run, between-run, and between-day results. (Specific %CV targets are not explicitly stated as acceptance criteria).	Total %CV for Level 1/Panel 141 control: 4.6%Total %CV for Level 2/Panel 142 control: 3.6%
Linearity	Demonstrate linearity up to a relevant clinical range.	Linear up to 180.0 mg/dL
Sensitivity (Limit of Quantitation)	Demonstrate an appropriate limit of quantitation for clinical use.	8.0 mg/dL

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

Sample Size: Not explicitly stated. The document mentions "Comparative performance studies were conducted" and "Precision studies were conducted using the Direct HDL assay," but does not provide the number of samples or subjects used in these studies.
Data Provenance: Not explicitly stated. The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given it's an IVD device, the samples would likely be human serum or plasma.

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

No. of Experts: Not applicable. This is an in vitro diagnostic assay that generates quantitative results. The "ground truth" for method comparison and precision studies is typically derived from the performance of a legally marketed predicate device (Boehringer Mannheim Direct HDL assay on the Hitachi 717 Analyzer) and established analytical control materials, respectively. Expert interpretation of images or clinical cases is not relevant for this type of device.
Qualifications: Not applicable for this type of device study.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. As this is an IVD assay providing quantitative values, there is no expert adjudication process in the traditional sense. The comparison is statistical against a predicate device or pre-defined analytical metrics.

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

MRMC Study: No, an MRMC study was not done. MRMC studies are typically performed for imaging or interpretation devices where human readers assess cases, often with and without AI assistance, to measure diagnostic accuracy and efficiency. This device is a quantitative chemical assay, not an imaging or interpretation aid.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance: Yes, the entire study focuses on the standalone performance of the Direct HDL assay. Since it is an in vitro diagnostic assay, its performance is inherently "standalone" in that it produces a quantitative result without human intervention in the measurement process (though a human ultimately interprets the result in a clinical context). The studies evaluate the assay's analytical performance (correlation with a predicate, precision, linearity, sensitivity).

7. The Type of Ground Truth Used

Type of Ground Truth:
- Method Comparison: The "ground truth" is established by the performance of the legally marketed Boehringer Mannheim Direct HDL assay on the Hitachi 717 Analyzer, which serves as the reference method.
- Precision and Linearity: The ground truth for these studies is typically established by using certified control materials or spiked samples with known concentrations, or by statistical analysis of repeat measurements. These are analytical benchmarks, not clinical ground truth like pathology or outcome data.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This is not a machine learning or AI-based device that requires a training set. It is a chemical assay with a defined reagent formulation and analytical method.

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

Ground Truth for Training Set: Not applicable, as there is no training set for this type of device. The assay's performance characteristics are inherent to its chemical and enzymatic design.

Summary

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510(k) Summary

Submitter's Name/Address Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038

Contact Person Mark Littlefield Section Manager MS 1-8 ADD Regulatory Affairs (972) 518-7861 Fax (972) 753-3367

Date of Preparation of this Summary:	Current date prepared
Device Trade or Proprietary Name:	HDL
Device Common/Usual Name or Classification Name:	Direct HDL
Classification Number/Class:	75LBS /Class I

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:

Test Description:

Direct HDL 510(k) April 2, 1998 HDL2.lwp

Section II Page 1

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Intended Use:

The Direct HDL assay is used for the quantitation of high-density lipoprotein cholesterol in serum or plasma.

Performance Characteristics:

Comparative performance studies were conducted using the ALCYON™ Analyzer. The Direct HDL assay method comparison yielded acceptable correlation with the Boehringer Mannheim Direct HDL assay on the Hitachi 717 Analyzer. The correlation coefficient = 0.9882 slope = 1.067, and Y-intercept = 0.372 mg/dL. Precision studies were conducted using the Direct HDL assay. Within-run, between-run, and between-day studies were performed using two levels of control material. The total %CV for Level 1/Panel 141 control is 4.6% and Level 2/Panel 142 is 3.6%. The Direct HDL assay is linear up to 180.0 mg/dL. The limit of quantititation (sensitivity) of the Direct HDL assay is 8.0 mg/dL. These data demonstrate that the performance of the Direct HDL assay is substantially equivalent to the performance of the Boehringer Mannheim Direct HDL assay on the Hitachi 717 Analyzer.

Conclusion:

The Direct HDL assay is substantially equivalent to the Boehringer Mannheim Direct HDL assay on the Hitachi 717 Analyzer as demonstrated by results obtained in the studies.

Direct HDL 510(k) April 2, 1998 HDL2.lwp

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Image /page/2/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 image of an eagle or bird with outstretched wings, positioned within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 3 1998

Mark Littlefield . Section Manager, Regulatory Affairs Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038

Re : K981224 Direct HDL Requlatory Class: I Product Code: IBS Dated: June 29, 1998 Received: June 30, 1998

Dear Mr. Littlefield:

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 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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਕ 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 QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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 requlations.

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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 (770) 488-7655.

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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Litman

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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1991224 510(k) Number (if known):

Direct HDL ___________________________________________________________________________________________________________________________________________________________________ Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) (Optional Format 1-2-96)

Over-The-Counter Use

(Division Sign-Off)
Division of Clinical Laboratory Devices
K941224

510(k) Number

0000007

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.