ULTRA HDL

K051962 · Abbott Laboratories · LBS · Aug 25, 2005 · Clinical Chemistry

Device Facts

• Record ID: K051962
• Device Name: ULTRA HDL
• Applicant: Abbott Laboratories
• Product Code: LBS · Clinical Chemistry
• Decision Date: Aug 25, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1475
• Device Class: Class 1

Intended Use

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 Story

Ultra HDL is an in vitro diagnostic assay for quantitative determination of HDL cholesterol in human serum or plasma. It utilizes a homogeneous two-reagent method requiring no off-line pretreatment or centrifugation. First reagent uses cholesterol oxidase to react with non-HDL unesterified cholesterol; peroxide generated is consumed by peroxidase reaction with DSBmT. Second reagent contains a detergent to selectively solubilize HDL cholesterol, cholesterol esterase, and a chromogenic coupler to develop color for quantification. Used in clinical laboratory settings on automated systems like AEROSET and ARCHITECT c8000. Healthcare providers use the resulting HDL concentration to assist in the diagnosis and treatment of coronary artery disease.

Clinical Evidence

Bench testing only. Performance was validated through precision studies (NCCLS EP5-A), linearity (NCCLS EP6-A), limit of quantitation (NCCLS EP17-A), and method comparison (NCCLS EP9-A2). Method comparison against the predicate on 110-111 patient samples showed high correlation (r=0.999) across the 12-188 mg/dL range. Interference testing confirmed robustness against hemoglobin, Intralipid, ascorbic acid, and bilirubin within ±5% at medical decision levels.

Technological Characteristics

Homogeneous enzymatic colorimetric assay. Two-reagent format. Reagents include cholesterol oxidase, peroxidase, DSBmT, detergent, cholesterol esterase, and chromogenic coupler. Designed for use on automated clinical chemistry analyzers (e.g., AEROSET, ARCHITECT c8000).

Indications for Use

Indicated for the quantitation of high-density lipoprotein (HDL) cholesterol levels in human serum or plasma. Used in the diagnosis and treatment of coronary artery disease.

Regulatory Classification

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.

Predicate Devices

• Genzyme N-genuous Ultra HDL Cholesterol Assay (k021316)

Submission Summary (Full Text)

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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 [phone] Fax [phone]

| 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 [phone]. 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 [phone] or [phone] 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:

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.

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)

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