(37 days)
Not Found
No
The device description and performance studies focus on chemical reactions and analytical measurements, with no mention of AI or ML.
No.
The device is used for the quantitation of high-density lipoprotein cholesterol levels for diagnosis, not for treatment.
Yes
The device is used for the quantitation of high-density lipoprotein cholesterol levels, and low HDL measurements are used in the diagnosis and treatment of coronary artery disease. This directly indicates its role in diagnosis.
No
The device description clearly outlines a chemical assay method involving reagents and enzymatic reactions, indicating a physical, wet-lab based diagnostic test, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the assay is used for the "quantitation of high-density lipoprotein cholesterol levels in human serum or plasma." This involves testing biological samples (serum or plasma) in vitro (outside the body).
- Indications for Use: The indications for use state that "Low HDL measurements are used in the diagnosis and treatment of coronary artery disease." This indicates that the results of the test are intended to provide information for diagnostic purposes.
- Device Description: The description details a laboratory assay that uses reagents and enzymatic reactions to measure a substance (HDL cholesterol) in a biological sample. This is characteristic of an in vitro diagnostic test.
- Performance Studies: The performance studies describe method comparisons and precision studies conducted on laboratory analyzers using the assay, further confirming its use in a laboratory setting for diagnostic testing.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LBS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 yielded 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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Correlation coefficient (AEROSET vs Hitachi 717): 0.999
Slope (AEROSET vs Hitachi 717): 0.97
Y-intercept (AEROSET vs Hitachi 717): 0.46 mg/dL
Correlation coefficient (ARCHITECT c8000 vs Hitachi 717): 0.999
Slope (ARCHITECT c8000 vs Hitachi 717): 0.97
Y-intercept (ARCHITECT c8000 vs Hitachi 717): 0.91 mg/dL
Correlation coefficient (ARCHITECT c8000 vs AEROSET): 0.999
Slope (ARCHITECT c8000 vs AEROSET): 1.00
Y-intercept (ARCHITECT c8000 vs AEROSET): 0.61 mg/dL
Total %CV (AEROSET, Level 1): 5.5%
Total %CV (AEROSET, Level 2): 1.4%
Total %CV (ARCHITECT c8000, Level 1): 3.3%
Total %CV (ARCHITECT c8000, Level 2): 1.4%
Linear range: 5 to 180 mg/dL
Limit of quantitation (sensitivity): 5 mg/dL
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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
000012 age 2
2
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.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three bars representing the agency's mission to promote health, well-being, and human services. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.
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).
4
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
5
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)
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
0000006