The Cholesterol assay is used for the quantitation of cholesterol in human serum or plasma. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

Device Description

Cholesterol is an in vitro diagnostic assay for the quantitative determination of cholesterol in human serum or plasma. The Cholesterol assay is a clinical chemistry assay in which cholesterol esters are enzymatically hydrolysed by cholesterol esterase to cholesterol and free fatty acids. Free cholesterol, including that originally present, is then oxidized by cholesterol oxidase to cholest-4-en-3-one and hydrogen peroxide. The hydrogen peroxide combines with Hydroxybenzoic Acid and 4-aminoantipyrine to form a chromophore (quinoneimine dye) which can be measured.

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets those criteria:

The provided document describes the Abbott Laboratories' Cholesterol assay, an in vitro diagnostic device, and its 510(k) summary for substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

This study establishes substantial equivalence to a predicate device rather than setting explicit acceptance criteria for diagnostic accuracy per se. The key performance characteristics are compared against a predicate device and a reference method.

Performance Characteristic	Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance (Abbott Cholesterol Assay)
Method Correlation	Acceptable correlation with the predicate device (Roche® Cobas Mira® Plus Automated Chemistry System Cholesterol assay).	Correlation coefficient = 0.9887, slope = 0.916, and Y-intercept = 0.206 mg/dL. This was deemed acceptable.
Traceability	Validation against the Abell-Kendall reference method. Implicitly, agreement with this gold standard is expected.	Validated against the Abell-Kendall reference method in a CDC-Certified Cholesterol Reference Method Network Laboratory (CRMLN). A Certificate of Traceability was included.
Precision	Acceptable within-run, between-run, and between-day precision using control material. Not explicitly quantified as an acceptance criterion in the text.	Total %CV for Level 1/Panel 111 control is 2.2%. Total %CV for Level 2/Panel 112 control is 2.7%.
Linearity Range	An acceptable linear range for cholesterol measurement. Not explicitly quantified as an acceptance criterion in the text.	Linear up to 530 mg/dL.
Limit of Quantitation	An acceptable limit of quantitation (sensitivity). Not explicitly quantified as an acceptance criterion in the text, but a specific value is reported.	0.970 mg/dL.
Overall Equivalence	The Cholesterol assay must demonstrate substantial equivalence in performance characteristics to the Roche® Cobas Mira® Plus Automated Chemistry System Cholesterol assay.	Demonstrated by the results of the comparative studies.

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 comparative performance studies or precision studies. It mentions two levels of control material for precision studies.
Data Provenance: Not specified. The document does not mention the country of origin of the data or whether the data was retrospective or prospective.

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

Number of Experts: Not applicable in the traditional sense for diagnostic image analysis. The "ground truth" for the method comparison was the Roche Cobas Mira Plus Automated Chemistry System Cholesterol assay and the Abell-Kendall reference method.
Qualifications of Experts: The Abell-Kendall reference method validation was conducted in a CDC-Certified Cholesterol Reference Method Network Laboratory (CRMLN). This implies expert-level operation and certification for cholesterol measurement. No individual expert qualifications are provided for the Roche Cobas Mira Plus assay's results, as it's a commercially available device.

4. Adjudication Method for the Test Set

Not applicable as this is not a study involving human readers or subjective interpretation of results requiring adjudication. The comparison is between quantitative chemical assays.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for devices that aid human readers in interpreting clinical images or other subjective data. This device is a quantitative in vitro diagnostic assay.

6. Standalone Performance Study

Yes, a standalone performance was done in the sense that the Abbott Cholesterol assay's performance (correlation, precision, linearity, limit of quantitation) was evaluated. However, this "standalone" evaluation was primarily in comparison to a predicate device and a reference method to establish substantial equivalence, rather than a standalone clinical utility study without any reference point. The entire submission is focused on demonstrating the device's intrinsic performance characteristics.

7. Type of Ground Truth Used

For Method Comparison: The ground truth for the primary comparative study was the results from the Roche Cobas Mira Plus Automated Chemistry System Cholesterol assay (predicate device) and the Abell-Kendall reference method (gold standard clinical chemistry reference method).
For Precision, Linearity, Limit of Quantitation: These were determined through experimental protocols using established laboratory practices (e.g., measuring known concentration controls, serially diluted samples).

8. Sample Size for the Training Set

Not applicable. This device is a biochemical assay, not an AI/machine learning algorithm requiring a "training set" in the computational sense. The "training" analogous to this would be the development and optimization of the reagent formulation and assay parameters based on laboratory experimentation and chemical principles.

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

Not applicable for the reasons stated above.

Summary

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

月981476

Section II

510(k) Summary

Cholesterol 510(k)
April 23, 1998
Chol510k.lwp

Section II

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

510(k) Summary

Submitter's Name/Address

Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038 Contact Person Mark Littlefield Section Manager MS 1-8 Regulatory Affairs (972) 518-7861 Fax (972) 753-3367

Date of Preparation of this Summary:	April 23, 1998
Device Trade or Proprietary Name:	Chol
Device Common/Usual Name or Classification Name:	Cholesterol
Classification Number/Class:	75CHH/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:

Cholesterol 510(k) April 23, 1998 Chol510k.lwp

Section II Page 1

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

Substantial Equivalence:

The Cholesterol assay is substantially equivalent to the following device:

Roche® Cobas Mira® Plus Automated Chemistry System Cholesterol assay . (K896239)
These assays yield similar Performance Characteristics.

Similarities to Roche:

Both assays are in vitro clinical chemistry methods. 새
Both assays can be used for the quantitative determination of cholesterol. .
Both assays vield similar clinical results. .
Both assays have the same assay range. .

Differences to Roche:

There is a minor difference in the analysis medium. .

Intended Use:

The Cholesterol assay is used for the quantitation of cholesterol in human serum or plasma.

Performance Characteristics:

Comparative performance studies were conducted using the ALCYON™ Analyzer. The Cholesterol assay method comparison vielded acceptable correlation with the Roche Cobas Mira Plus Automated Chemistry System Cholesterol assay. The correlation coefficient = 0.9887, slope = 0.916, and Y-intercept = 0.206 mg/dL. The ALCYON Cholesterol reagent was validated against the Abell-Kendall reference method in a CDC-Certified Cholesterol Reference Method Network Laboratory (CRMLN). A copy of the CRMLN Certificate of Traceability is included in Section III.F. Precision studies were conducted using the Cholesterol assay. Within-run, between-run, and between-day studies were performed using two levels of control material. The total %CV for Level 1/Panel 111 control is is 2.2% and Level 2/Panel 1 12 is 2.7%. The Cholesterol assay is linear up to 530 mg/dL.

Section II Page 2

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

The limit of quantitation (sensitivity) of the Cholesterol assay is 0.970 mg/dL. These data demonstrate that the performance of the Cholesterol assay is substantially equivalent to the performance of the Roche Cobas Mira Plus Automated Chemistry System Cholesterol assay.

Conclusion:

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

Cholesterol 510(k) April 23, 1998 Chol510k.lwp

Section II Page 3

Image /page/3/Picture/5 description: The image shows a sequence of numbers. The numbers are 0000014. The numbers are printed in a bold, slightly distressed font, giving them a vintage or aged appearance. The background is plain and white.

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

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle faces to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 2 5 1998

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

K981476 Re : Cholesterol Regulatory Class : I Product Code: CHH Dated: April 23, 1998 Received: April 24, 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸੁਤੰ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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.

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

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 marrosed promits 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 Bitman

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

{6}------------------------------------------------

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Cholesterol __________________________________________________________________________________________________________________________________________________________________ Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

Cholesterol

Carroll C. Bensinger Alfred Montgomery
(Division Sign-Off)

Division of Clinical Laboratory Dev 510(k) Number

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

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concyrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ Prescription Use V OR (Per 21 CFR 801.109)

(Optional Format 1-2-96)

Regulation Number and Section

§ 862.1175 Cholesterol (total) test system.

(a)
Identification. A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.(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.