The Apolipoprotein B assay is used for the quantitation of apolipoprotein B in human serum or plasma. Apolipoprotein B meaurements are useful in the diagnosis of premature coronary artery disease, hyper-b-lipoproteinemia, and hypo-b-lipoproteinemia.

Device Description

Apolipoprotein B is an in vitro diagnostic assay for the quantitative determination of apolipoprotein B in human serum or plasma. Antibodies to apolipoprotein B combine with apolipoprotein B in the sample to form insoluble immune complexes. The immune complexes cause an increase in light scattering (turbidity). The resulting increase in sample turbidity, measured at 604 nm, is directly proportional to the concentration of apolipoprotein B in the sample.

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and the study used to demonstrate equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Metric	Predicate Device (K-ASSAY® Apo B on Hitachi® 717 Analyzer)	Submitted Device (ApoB on AEROSET™ System)	Result/Performance	Acceptance Status
Method Comparison	Correlation Coefficient	N/A (Comparator)	N/A (Submitted Device)	0.9793	Met (Excellent)
	Slope	N/A (Comparator)	N/A (Submitted Device)	1.064	Met (Close to 1)
	Y-intercept	N/A (Comparator)	N/A (Submitted Device)	-2.920 mg/dL	Met (Small value)
Precision	Total %CV (Level 1)	N/A (No specific value given for predicate)	N/A (Submitted Device)	2.5%	Met (Good)
	Total %CV (Level 2)	N/A (No specific value given for predicate)	N/A (Submitted Device)	1.8%	Met (Good)
Assay Range	Quantitative Range	N/A (A difference noted, but no specific value for predicate)	N/A (Submitted Device)	1.55 to 285.31 mg/dL	Met
Sensitivity	Limit of Quantitation	N/A (No specific value given for predicate)	N/A (Submitted Device)	1.55 mg/dL	Met
Qualitative Equivalence	Similar clinical results	Yes	Yes	Achieved	Met
	In Vitro Immunoassay	Yes	Yes	Achieved	Met
	Quantitative Determination	Yes	Yes	Achieved	Met
	Immune Complex Formation	Yes	Yes	Achieved	Met

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

The document does not explicitly state the sample size used for the comparative performance studies. It mentions "Comparative performance studies were conducted," but details on the number of samples are absent.

Regarding data provenance: The studies were conducted by Abbott Laboratories, in support of their submission to the FDA. The specific country of origin for the samples is not mentioned, nor is it explicitly stated whether the study was retrospective or prospective. Given the nature of a 510(k) submission for an in vitro diagnostic, these are typically laboratory-based studies using patient samples, but the exact details are not provided.

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

This information is not applicable to an in vitro diagnostic assay like ApoB. "Ground truth" in this context refers to the established true value of apolipoprotein B in a sample. For diagnostic assays, the "ground truth" for the test set is typically established by using a reference method or a legally marketed predicate device, rather than expert consensus on images or clinical cases. In this case, the predicate device (K-ASSAY® Apo B on the Hitachi® 717 Analyzer) served as the defacto "ground truth" or comparator for the new device's performance.

4. Adjudication Method for the Test Set

Not applicable. As this is an in vitro diagnostic assay comparing performance against a predicate, there is no need for adjudication by human experts in the way it would be applied to, for example, image interpretation. The comparison is objective and quantitative.

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 relevant for devices that involve human interpretation, such as diagnostic imaging AI, where the impact of AI assistance on human reader performance is evaluated. The ApoB assay is an automated in vitro diagnostic test.

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

Yes, the study described is a standalone performance study of the ApoB assay. It assesses the assay's performance characteristics (correlation, precision, range, sensitivity) as an isolated device on the AEROSET™ System, comparing its results to those obtained from a predicate device. There is no human-in-the-loop component in the operation or result generation for this type of assay.

7. The Type of Ground Truth Used

The "ground truth" in this context is the results obtained from the legally marketed predicate device, the K-ASSAY® Apo B on the Hitachi® 717 Analyzer. The new device's measurements are compared directly to the measurements of this established and accepted method.

8. The Sample Size for the Training Set

No information regarding a "training set" or its sample size is provided. For an in vitro diagnostic assay like this, the development typically involves analytical validation studies rather than machine learning model training. The assay's parameters (e.g., reagent concentrations, reaction times) would be optimized during development, but this is not typically referred to as a "training set" in the context of AI/ML.

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

Not applicable, as there is no mention of a "training set" in the context of machine learning. The "ground truth" for developing such an assay would be based on established analytical chemistry principles, reference materials, and clinical validation against known patient samples, but these details are not provided in this summary.

Summary

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510(k) Summary

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

Contact Person Linda Morris Senior Regulatory Specialist MS 1-8 Regulatory Affairs (972) 518-6711 Fax (972) 753-3367

Date of Preparation of this Summary:	September 17, 1998
Device Trade or Proprietary Name:	ApoB
Device Common/Usual Name or Classification Name:	Apolipoprotein B
Classification Number/Class:	Class II

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: 19983381.

Test Description:

Apolipoprotein B 510(k) September 17, 1998 ApoB VI.lwp

Section II Page 1

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Substantial Equivalence:

The Apolipoprotein B assay is substantially equivalent to the K-ASSAY® Apo B (K964296/S022) on the Hitachi® 717 Analyzer.

Both assays yield similar Performance Characteristics.

Similarities:

Both assays are in vitro immunoassay methods. .
Both assays can be used for the quantitative determination of apolipoprotein B. .
. Both assays yield similar clinical results.
Both assays are based on the formation of immune complexes. .

Differences:

There is a difference between the assay range. .

Intended Use:

The Apolipoprotein B assay is used for the quantitation of apolipoprotein B in human serum or plasma.

Performance Characteristics:

Comparative performance studies were conducted using the AEROSET™ System. The Apolipoprotein B assay method comparison yielded acceptable correlation with the K-ASSAY Apo B on the Hitachi 717 Analyzer. The correlation coefficient = 0.9793, slope = 1.064, and Y-intercept = - 2.920 mg/dL. Precision studies were conducted using the Apolipoprotein B assay. Within-run, between-run, and between-day studies were performed using two levels of control material. The total %CV for Level 1/Panel 401 is 2.5% and Level 2/Panel 402 is 1.8%. The Apolipoprotein B assay range is 1.55 to 285.31 mg/dL. The limit of quantitation (sensitivity) for the Apolipoprotein B assay is 1.55 mg/dL. These data demonstrate that the performance of the Apolipoprotein B assay is substantially equivalent to the performance of the K-ASSAY Apo B on the Hitachi 717 Analyzer.

Apolipoprotein B 510(k) September 17, 1998 ApoB_VI.Wp

Section II Page 2

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Conclusion:

The Apolipoprotein B assay is substantially equivalent to the K-ASSAY Apo B on the Hitachi 717 Analyzer as demonstrated by results obtained in the studies.

Apolipoprotein B 510(k)
September 17, 1998 ApoB_VI.lwp

Section II Page 3

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

JAN 26 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Linda Morris Senior Regulatory Specialist Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038

Re: K983281 Trade Name: Apolipoprotein B Regulatory Class: II Product Code: DFC Dated: December 3, 1998 Received: December 4, 1998

Dear Ms. Morris:

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 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). 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 (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 (OS) 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 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/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

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): _K98 328 L

Device Name: _____________ Apolipoprotein B

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 Over-The-Counter Use OR (Per 21 CFR 801.109)

(Optional Format 1-2-96)

Shana T. Laggosini

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K983281

Regulation Number and Section

§ 866.5600 Low-density lipoprotein immunological test system.

(a)
Identification. A low-density lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the low-density lipoprotein in serum and other body fluids. Measurement of low-density lipoprotein in serum may aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify young persons at risk from cardiovascular diseases.(b)
Classification. Class II (performance standards).