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

Here's an analysis of the provided text regarding the acceptance criteria and study for the Direct HDL device:

Acceptance Criteria and Device Performance Study for Direct HDL Assay

This submission describes the Abbott Laboratories' Direct HDL assay, an in vitro diagnostic for quantitative determination of high-density lipoprotein cholesterol. The study aims to demonstrate substantial equivalence to a legally marketed predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Method Comparison	Good correlation (e.g., r > 0.95, slope near 1, small y-intercept) compared to predicate device	Correlation coefficient (r) = 0.9883, Slope = 1.041, Y-intercept = 0.118 mg/dL (vs. Boehringer Mannheim Direct HDL-Cholesterol assay on Hitachi 717 Analyzer)
Precision (Total %CV)	Within acceptable ranges for diagnostic assays	Level 1/Panel 109: 5.3% Level 2/Panel 110: 3.3%
Linearity (Upper Limit)	At least comparable to predicate; clinically relevant range	Linear up to 309.6 mg/dL
Limit of Quantitation (Sensitivity)	Clinically relevant lower limit	1.2 mg/dL

Note: The document does not explicitly state pre-defined acceptance criteria values for r, slope, y-intercept, %CV, linearity, or sensitivity. These are inferred from standard practices for establishing substantial equivalence in diagnostic assays.

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

Sample Size for Test Set: The document does not explicitly state the sample size (number of patient samples) used for the comparative performance studies (method comparison, precision, linearity, sensitivity). It mentions "two levels of control material" for precision studies, but this refers to internal quality control, not patient samples for the test set.
Data Provenance: Not specified. The document does not mention the country of origin of the data or whether the study was retrospective or prospective.

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

This is an in vitro diagnostic assay for measuring a specific analyte (HDL cholesterol). As such, the "ground truth" is established by a reference method or a legally marketed predicate device, not by expert interpretation of images or clinical findings. Therefore, information regarding "number of experts" and their "qualifications" for establishing ground truth is not applicable in this context. The Boehringer Mannheim Direct HDL-Cholesterol assay on the Hitachi 717 Analyzer serves as the reference for comparison.

4. Adjudication Method for the Test Set

Not Applicable. As explained above, the ground truth is based on a quantitative chemical measurement by a reference assay, not on subjective assessment requiring adjudication.

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

No. An MRMC study is relevant for diagnostic imaging systems where human readers interpret medical images. This document describes an in vitro diagnostic assay, where the output is a quantitative chemical value, not an image requiring human interpretation for diagnosis. Therefore, an MRMC study was not performed and is not applicable.

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

Yes, implicitly. This is a standalone diagnostic assay. The performance characteristics (method comparison, precision, linearity, sensitivity) described reflect the performance of the device itself (the "algorithm only" in a broader sense of an automated assay) without human intervention in the quantitative measurement process (beyond operating the instrument and interpreting the numerical result). The study compares the performance of the Abbott Direct HDL assay to another automated assay.

7. The Type of Ground Truth Used

The ground truth for the comparison study was based on measurements obtained from the Boehringer Mannheim Direct HDL-Cholesterol assay on the Hitachi 717 Analyzer, which is a legally marketed predicate device. This essentially uses an established, accepted diagnostic method as the reference standard.

8. The Sample Size for the Training Set

Not applicable/Not specified. For a commercially available assay like this, typically the "training" phase refers to the assay development and optimization itself. There is no explicit mention of a "training set" in the context of machine learning, as this is a chemical assay, not an AI or machine learning algorithm in the modern sense. If prior studies or method development involved a "training" equivalent, the details are not provided in this 510(k) summary.

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

Not applicable/Not specified. As mentioned above, the concept of a "training set" and its associated ground truth establishment is not directly relevant to this type of chemical assay as it would be for a machine learning model. The development of the assay itself would have involved laboratory optimization and characterization experiments to ensure its chemical specificity and performance.

Summary

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JUN 11 1998

K981/580

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) 518-6062 Fax (972) 753-3367

Date of Preparation of this Summary:	May 1, 1998
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) May 1, 1998 Aero HDLf.lwp

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Substantial Equivalence:

The Direct HDL assay is substantially equivalent to the Boehringer Mannheim® Direct HDL-Cholesterol assay (K963213) on the Hitachi® 717 Analyzer. These assays yield similar Performance Characteristics.

Similarities:

Both assays are in vitro clinical chemistry methods. .
Both assays can be used for the quantitative determination of Direct HDL. .
Both assays yield similar clinical results. .

Differences:

There is a difference between the assay range. .

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 AEROSET™ System. The Direct HDL assay method comparison yielded acceptable correlation with the Boehringer Mannheim Direct HDL-Cholesterol assay on the Hitachi 717 Analyzer. The correlation coefficient = 0.9883, slope =1.041, and Y-intercept =0.118 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 109 is 5.3% and Level 2/Panel 110 is 3.3%. The Direct HDL assay is linear up to 309.6 mg/dL. The limit of quantititation (sensitivity) of the Direct HDL assay is 1.2 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-Cholesterol assay on the Hitachi 717 Analyzer.

Direct HDL 510(k) May 1, 1998 Aero HDLf.lwp

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Conclusion:

College Commend Comments of Children

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

Direct HDL 510(k)
May 1, 1998
Aero HDLf.lwp

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JUN 11 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re : K981580 Direct HDL Requlatory Class: I Product Code: LBS Dated: May 1, 1998 Received: May 4, 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 of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labelinq, and prohibitions against 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A 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 Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements 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 regulations.

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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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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)

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Over-The-Counter Use

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(Division
Division
510(k) Number K984580

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.