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

Device Description

The Ultra HDL assay is a homogeneous method for directly measuring HDL cholesterol concentrations in serum or plasma without the need for any off-line pretreatment or centrifugation steps. The method uses a two-reagent format and depends on the properties of a unique detergent. This method is based on accelerating the reaction of cholesterol oxidase (CO) with non-HDL unesterified cholesterol and dissolving HDL cholesterol selectively using a specific detergent. In the first reagent, non-HDL unesterified cholesterol is subject to an enzyme reaction and the peroxide generated is consumed by a peroxidase reaction with DSBmT yielding a colorless product. The second reagent consists of a detergent (capable of solubilizing HDL cholesterol), cholesterol esterase (CE), and chromagenic coupler to develop color for the quantitative determination of HDL cholesterol.

AI/ML Overview

Acceptance Criteria and Reported Device Performance:

Performance Metric	Acceptance Criteria (Predicate Device K021316)	Ultra HDL Performance (AEROSET System)	Ultra HDL Performance (ARCHITECT c8000 System)
Correlation Coefficient (vs. Predicate)	Acceptable correlation	0.999	0.999
Slope (vs. Predicate)	Acceptable correlation	0.97	0.97
Y-intercept (vs. Predicate)	Acceptable correlation	0.46 mg/dL	0.91 mg/dL
Inter-system Correlation (AEROSET vs. ARCHITECT)	Acceptable correlation	-	Correlation Coefficient: 0.999, Slope: 1.00, Y-intercept: 0.61 mg/dL
Total %CV (Level 1)	Not explicitly stated for predicate, but performance demonstrated as "substantially equivalent"	5.5%	3.3%
Total %CV (Level 2)	Not explicitly stated for predicate, but performance demonstrated as "substantially equivalent"	1.4%	1.4%
Linearity Range	Not explicitly stated for predicate, but performance demonstrated as "substantially equivalent"	5 to 180 mg/dL	5 to 180 mg/dL
Limit of Quantitation (Sensitivity)	Not explicitly stated for predicate, but performance demonstrated as "substantially equivalent"	5 mg/dL	5 mg/dL

Note: The acceptance criteria are inferred from the claim of "substantially equivalent" performance to the predicate device (Genzyme N-geneous Ultra HDL Cholesterol assay). Exact numerical acceptance criteria for the predicate are not provided in the document, but the study demonstrates that the Ultra HDL assay achieved comparable results.

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not explicitly state the specific number of individual patient or control samples used in the "Comparative performance studies" or "Precision studies." It refers to "Level 1" and "Level 2" for precision, implying control materials or different concentration ranges.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not applicable. This is an in vitro diagnostic device for quantitative measurement, not an imaging device requiring expert interpretation for ground truth. The 'ground truth' is established by the predicate device's measurements.
Adjudication Method for the Test Set:
- Not applicable. This is not a study involving expert adjudication of diagnostic findings.
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 for imaging devices where human readers interpret images, sometimes with and without AI assistance. This device is an in vitro diagnostic assay.
Standalone Performance (Algorithm Only without Human-in-the-Loop):
- Yes, this study demonstrates the standalone performance of the Ultra HDL assay. It directly measures HDL cholesterol concentrations in serum or plasma. It is designed to be used without human-in-the-loop analysis beyond operating the instrument and interpreting the numerical output.
Type of Ground Truth Used:
- The "ground truth" for evaluating the Ultra HDL assay was the results obtained from the Genzyme N-geneous Ultra HDL Cholesterol assay on the Hitachi 717 Analyzer, which is the predicate device. This is a form of comparative ground truth against an established and legally marketed method.
Sample Size for the Training Set:
- The document does not specify a separate "training set" or its sample size. For an in vitro diagnostic assay, method development and optimization would occur prior to these performance studies, but the data presented focuses on the validation of the final assay.
How the Ground Truth for the Training Set Was Established:
- Not applicable, as a distinct training set and its ground truth establishment are not described in the context of this 510(k) summary for an in vitro diagnostic assay. The performance evaluation is against an established predicate device.

Summary

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AUG 2 5 2005

510(k) Summary

Submitter's Name/Address Abbott Laboratories 1920 Hurd Drive Irving, TX 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:	July 12, 2005
Device Trade or Proprietary Name:	Ultra HDL
Device Common/Usual Name or Classification Name:	Ultra HDL
Classification Number/Class:	LBS/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: K 651962

Test Description:

The Ultra HDL assay is a homogeneous method for directly measuring HDL cholesterol concentrations in serum or plasma without the need for any off-line pretreatment or centrifugation steps.

The method uses a two-reagent format and depends on the properties of a unique detergent. This method is based on accelerating the reaction of cholesterol oxidase (CO) with non-HDL unesterified cholesterol and dissolving HDL cholesterol selectively using a specific detergent. In the first reagent, non-HDL unesterified cholesterol is subject to an enzyme reaction and the peroxide generated is consumed by a peroxidase reaction with DSBmT yielding a colorless product. The scoond reagent consists of a detergent (capable of solubilizing HDL cholesterol), cholesterol esterass (CE), and chromagenic coupler to develop color for the quantitative determination of HDL cholesterol.

Ultra HDL 510(k) July 12, 2005

Section II Page 1 000011

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Substantial Equivalence:

The Ultra HDL assay is substantially equivalent to the Genzyme N-geneous Ultra HDL Cholesterol assay (K021316) on the Hitachi® 717 Analyzer. These assays yield similar Performance Characteristics.

Similarities:

Both assays use the same in vitro clinical chemistry methodology. .
Both assays can be used for the quantitative determination of HDL. .
Both assays yield similar clinical results. .

Differences:

None

Intended Use:

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

Performance Characteristics:

Comparative performance studies were conducted using the AEROSET® System and ARCHITECT® c8000 System. The Ultra HDL assay method comparison yielded acceptable correlation with the Genzyme N-geneous Ultra HDL Cholesterol assay on the Hitachi 717 Analyzer. The AEROSET System showed a correlation coefficient of 0.999, slope of 0.97, and Y-intercept of 0.46 mg/dL when compared to the Hitachi 717 Analyzer. The ARCHITECT c8000 System showed a correlation coefficient of 0.999, slope of 0.97, and Y-intercept of 0.91 mg/dL when compared to the Hitachi 717 Analyzer. The Ultra HDL assay method comparison yiclded acceptable correlation between the AEROSET System and ARCHITECT c8000 System. The ARCHITECT c8000 System showed a correlation coefficient of 0.999, slope of 1.00, and Y-intercept of 0.61 mg/dL when compared to the AEROSET System. Precision studies were

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conducted using the Ultra HDL assay. On the AEROSET System, the total %CV for Level 1 is 5.5%, and Level 2 is 1.4%. On the ARCHITECT c8000 System, the total %CV for Level 1 is 3.3%, and Level 2 is 1.4%. The Ultra HDL assay is linear from 5 to 180 mg/dL. The limit of quantitation (sensitivity) of the Ultra HDL assay is 5 mg/dL. These data demonstrate that the performance of the Ultra HDL assay is substantially equivalent to the performance of the Genzyme N-geneous Ultra HDL Cholesterol assay on the Hitachi 717 Analyzer.

Conclusion:

The Ultra HDL assay is substantially equivalent to Genzyme N-geneous Ultra HDL Cholesterol assay on the Hitachi 717 Analyzer as demonstrated by results obtained in the studies.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 2 5 2005

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

K051962 Re: Trade/Device Name: Ultra HDL Regulation Number: 21 CFR § 862.1475 Regulation Name: Lipoprotein test system Regulatory Class: I Product Code: LBS Dated: July 12, 2005 Received: July 19, 2005

Dear Ms. Morris:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 use stated in the encroours) to trgans actment date of the Medical Device Amendments, or to commerce processified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Costietic (110) (110) that to device, subject to the general controls provisions of the Act. The r ou may, merelove, mains of the Act include requirements for annual registration, listing of general controls provision practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is elabilional controls. Existing major regulations affecting your device can may or subject to Satin and Federal Regulations (CFR), Parts 800 to 895. In addition, FDA be found in Trire By, Occoments concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loase of advised that i Drivisean that your device complies with other requirements of the Act that I DA has intace a sond regulations administered by other Federal agencies. You must or any I cacal statutes and regaranents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will allow you to begin matic-mig your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalence of your premarket notification. The PDF Imaning of Sween in Tour device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, If you desire specific information acourtising of your device, please contact the Office of In
or questions on the promotion and advertising of your and any and one office of or questions on the promotion and advertising or your and Safety at (240) 276-0484. Also, plant for VIIto Diagnostic Device Dranation and Bassy of (" (" (" (" (" (" ( 2 ) Part 807.97).
regulation entitled, "Misbranding by reference to premarket notification the You may obtain other general information on your responsibilities under the Act from the You may of all other general informations on Jour responser Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Carol C. Benson

Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): _ K の 5 / 1 レ 1

Ultra HDL ____________________________________________________________________________________________________________________________________________________________________ Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

Sign-Off Division Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)________________________________________________________________________________________________________________________________________________________________________

Prescription Use_ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use_ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics Devices (OIVD)

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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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.