The LDL assay is used for the quantitation of low-density lipoprotein cholesterol levels in human serum or plasma. LDL measurements are used in the diagnosis and treatment of the pathogensis of arteriosclerosis and coronary artery disease.

Device Description

LDL is an in vitro diagnostic assay for the quantitative determination of low-density lipoprotein cholesterol (LDL) in human serum or plasma. The detergent solubilizes only the non-LDL lipoprotein particles. The cholesterol released is consumed by cholesterol esterase and cholesterol oxidase in a non-color forming reaction. Another detergent solubilizes the remaining LDL particles and a chromogenic coupler allows for color formation. The enzyme reaction with LDL cholesterol in the presence of the coupler produces color which is proportional to the amount of LDL cholesterol present in the sample.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the LDL assay:

1. Table of Acceptance Criteria and Reported Device Performance

The submission doesn't explicitly define formal "acceptance criteria" with specified thresholds for each performance characteristic. Instead, it presents performance characteristics and asserts that they demonstrate "substantial equivalence" to the predicate device. For the purpose of this table, I will infer the "acceptance criteria" as the performance demonstrated during the study being considered acceptable for substantial equivalence.

Performance Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance
Method Comparison	Acceptable correlation with predicate device (Roche Cobas Mira Plus Automated Chemistry System)	Correlation coefficient = 0.9546, Slope = 0.984, Y-intercept = 7.466 mg/dL
Precision (Total %CV)	Acceptable precision using control material	Level 1/Panel 141 control: 3.3% Level 2/Panel 142 control: 4.0%
Linearity	Linear up to a high concentration	Linear up to 600 mg/dL
Limit of Quantitation	Low sensitivity value	1 mg/dL

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

Sample Size: The document does not explicitly state the sample size (number of patient samples) used for the method comparison or precision studies. It mentions "two levels of control material" for precision.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The studies were described as "Comparative performance studies were conducted using the ALCYON™ Analyzer."

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

This section is not applicable to this type of in vitro diagnostic device (IVD) submission. For chemical assays like LDL, the "ground truth" is typically established by reference methods, well-characterized control materials, or clinical outcomes, rather than expert interpretation of images or other subjective data. No experts for ground truth establishment are mentioned.

4. Adjudication Method for the Test Set

This section is not applicable. Since the device measures a chemical analyte, there is no subjective interpretation requiring adjudication by experts.

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

This section is not applicable. MRMC studies are relevant for devices that involve human interpretation (e.g., imaging diagnostics). This device is an automated in vitro diagnostic assay.

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

Yes, the performance presented is standalone. This device is an automated in vitro diagnostic assay. The performance characteristics described (correlation coefficient, precision, linearity, sensitivity) are inherent to the assay and the analyzer, without human intervention in the measurement process itself. Human involvement would primarily be in sample preparation, running the test, and interpreting the numerical results.

7. The Type of Ground Truth Used

The ground truth for this device's performance is established by comparison to a legally marketed predicate device (Roche Cobas Mira Plus Automated Chemistry System LDL assay) for method comparison, and by using control materials with known values for precision and linearity assessment. The concept of "expert consensus," "pathology," or "outcomes data" as ground truth is not relevant for this type of chemical assay.

8. The Sample Size for the Training Set

This section is not applicable. In vitro diagnostic assays like the LDL assay are typically developed and validated against established chemical principles and reference methods. They do not generally involve "training sets" in the same way machine learning algorithms do, where a model "learns" from a dataset. The formulation and calibration of the assay are based on chemical reactions, and performance is verified through analytical studies.

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

This section is not applicable for the same reasons mentioned in point 8.

Summary

{0}------------------------------------------------

K981303

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:	April 9, 1998
Device Trade or Proprietary Name:	Direct LDL
Device Common/Usual Name or Classification Name:	LDL
Classification Number/Class:	75JGJ/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.

X961303 The assigned 510(k) number is: __

Test Description:

DI . 510/k) Anni 9, 1998 Section II Page 1

0000012

AUG

{1}------------------------------------------------

Substantial Equivalence:

The LDL assay is substantially equivalent to the Roche Cobas Mira Automated

Chemistry assay.

Similarities:

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

Differences:

There is a difference between the assay range. .
There is a difference between the assay principles. .
There is a difference between reagent handling in that LDL is a two-reagent . kit and the Roche® Cobas Mira® Plus Automated Chemistry System LDL Cholesterol (Direct) assay is single-reagent kit.

Intended Use:

The LDL assay is used in the quantiation of low-density lipoprotein cholesterol levels in serum or plasma.

Performance Characteristics:

Comparative performance studies were conducted using the ALCYON™ Analyzer. The LDL assay method comparison yielded acceptable correlation with the Roche Cobas Mira Plus Automated Chemistry System LDL assay for serum. The correlation coefficient = 0.9546, slope = 0.984, and Y-intercept = 7.466 mg/dL. Precision studies were conducted using the LDL 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 3.3% and Level 2/Panel 142 is 4.0%. The LDL assay is linear up to 600 mg/dL. The limit of quantititation (sensitivity) of the LDL assay is 1 mg/dL. These data demonstrate that the performance of the LDL assay is

LDL 510(k) April 9, 1998 LDLE2.lwp

Section II Page 2

{2}------------------------------------------------

981303

substantially equivalent to the performance of the Roche Cobas Mira Plus Automated Chemistry System LDL assay for serum.

Conclusion:

The LDL assay is substantially equivalent to the Roche Cobas Mira Plus Automated Chemistry System LDL assay as demonstrated by results obtained in the studies.

LDL 510(k) April 9, 1998
LDLE2.lwp Section II Page 3

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) of the United States. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

3 1698 AUG

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

Re : K981303 LDL Requlatory Class: I Product Code: MRR Dated: July 2, 1998 Received: July 6, 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 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 Requlations, Title 21, Parts 800 to 895. ਜੋ 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 requlation may result in requlatory 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 regulations.

{4}------------------------------------------------

Page 2

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 yitro 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 Gutman

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

{5}------------------------------------------------

510(k) Number (if known): _ V 9 0 30 3

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)
OR	Over-The-Counter Use _____
	(Optional Format 1-2-96)

Division Sign-Off
Division of Clinical Laboratory Devices
10(k) Number	r981303

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.