(122 days)
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No
The device description details a chemical assay based on enzymatic reactions and selective detergents, with no mention of AI or ML techniques. The performance studies focus on standard analytical metrics like correlation, precision, and linearity.
No.
The device is an in vitro diagnostic assay used for the quantitative determination of high-density lipoprotein cholesterol levels, which is for diagnosis and treatment assessment, not for direct therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section states, "Low Direct HDL measurements are used in the diagnosis and treatment of coronary artery disease." This directly indicates its role in diagnosis. The "Device Description" also specifies it as an "in vitro diagnostic assay."
No
The device description clearly states it is an "in vitro diagnostic assay" and describes chemical reagents and their interactions with biological samples (serum or plasma). This indicates a physical, chemical-based test, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the assay is used for the "quantitation of high-density lipoprotein cholesterol levels in human serum or plasma." This indicates that the device is intended to be used on samples taken from the human body.
- Device Description: The "Device Description" further clarifies that it is an "in vitro diagnostic assay for the quantitative determination of high-density lipoprotein cholesterol in serum or plasma." The term "in vitro" means "in glass" or "in the lab," referring to tests performed outside of the living organism.
- Purpose: The assay is used to measure a specific substance (HDL cholesterol) in a biological sample (serum or plasma) to aid in the "diagnosis and treatment of coronary artery disease." This aligns with the definition of an IVD, which is used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
N/A
Intended Use / Indications for Use
The Direct HDL assay is used for the quantitation of high-density lipoprotein cholesterol in serum or plasma.
The Direct HDL assay is used for the quantitation of high-density lipoprotein cholesterol levels in human serum or plasma. Low Direct HDL measurements are used in the diagnosis and treatment of coronary artery disease.
Product codes (comma separated list FDA assigned to the subject device)
75LBS
Device Description
Direct HDL is an in vitro diagnostic assay for the quantitative determination of high-density lipoprotein cholesterol in serum or plasma. The Direct HDL assay is a two reagent format and depends on the properties of a unique detergent. This detergent solubilizes only the HDL lipoprotein particles, thus releasing the HDL cholesterol to react with cholesterol esterase and cholesterol oxidase, in the presence of chromogens to produce color. In addition to selectively disrupting the HDL lipoprotein particles, this unique detergent also inhibits the reaction of the cholesterol enzymes with LDL, VLDL, and chylomicron lipoproteins by adsorbing to their surfaces. A polyanion is contained in the first reagent to assist with complexing LDL, VLDL, and chylomicron lipoproteins, further enhancing the selectivity of the detergent and enzymes for HDL cholesterol.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparative performance studies were conducted using the ALCYON™ Analyzer. The Direct HDL assay method comparison yielded acceptable correlation with the Boehringer Mannheim Direct HDL assay on the Hitachi 717 Analyzer. Precision studies were conducted using the Direct HDL assay. Within-run, between-run, and between-day studies were performed using two levels of control material.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The correlation coefficient = 0.9882 slope = 1.067, and Y-intercept = 0.372 mg/dL. The total %CV for Level 1/Panel 141 control is 4.6% and Level 2/Panel 142 is 3.6%. The Direct HDL assay is linear up to 180.0 mg/dL. The limit of quantititation (sensitivity) of the Direct HDL assay is 8.0 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.
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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.
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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).
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§ 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.
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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: | Current date prepared |
|---|---|
| Device Trade or Proprietary Name: | HDL |
| Device Common/Usual Name or Classification Name: | Direct HDL |
| Classification Number/Class: | 75LBS /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:
Direct HDL is an in vitro diagnostic assay for the quantitative determination of high-density lipoprotein cholesterol in serum or plasma. The Direct HDL assay is a two reagent format and depends on the properties of a unique detergent. This detergent solubilizes only the HDL lipoprotein particles, thus releasing the HDL cholesterol to react with cholesterol esterase and cholesterol oxidase, in the presence of chromogens to produce color. In addition to selectively disrupting the HDL lipoprotein particles, this unique detergent also inhibits the reaction of the cholesterol enzymes with LDL, VLDL, and chylomicron lipoproteins by adsorbing to their surfaces. A polyanion is contained in the first reagent to assist with complexing LDL, VLDL, and chylomicron lipoproteins, further enhancing the selectivity of the detergent and enzymes for HDL cholesterol.
Direct HDL 510(k) April 2, 1998 HDL2.lwp
Section II Page 1
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224
Intended Use:
The Direct HDL assay is used for the quantitation of high-density lipoprotein cholesterol in serum or plasma.
Performance Characteristics:
Comparative performance studies were conducted using the ALCYON™ Analyzer. The Direct HDL assay method comparison yielded acceptable correlation with the Boehringer Mannheim Direct HDL assay on the Hitachi 717 Analyzer. The correlation coefficient = 0.9882 slope = 1.067, and Y-intercept = 0.372 mg/dL. Precision studies were conducted using the Direct HDL 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 4.6% and Level 2/Panel 142 is 3.6%. The Direct HDL assay is linear up to 180.0 mg/dL. The limit of quantititation (sensitivity) of the Direct HDL assay is 8.0 mg/dL. These data demonstrate that the performance of the Direct HDL assay is substantially equivalent to the performance of the Boehringer Mannheim Direct HDL assay on the Hitachi 717 Analyzer.
Conclusion:
The Direct HDL assay is substantially equivalent to the Boehringer Mannheim Direct HDL assay on the Hitachi 717 Analyzer as demonstrated by results obtained in the studies.
Direct HDL 510(k) April 2, 1998 HDL2.lwp
Section II Page 2 00014
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with outstretched wings, positioned within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 3 1998
Mark Littlefield . Section Manager, Regulatory Affairs Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038
Re : K981224 Direct HDL Requlatory Class: I Product Code: IBS Dated: June 29, 1998 Received: June 30, 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 aqainst 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. ਕ 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 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.
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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 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 Litman
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
4
1991224 510(k) Number (if known):
Direct HDL ___________________________________________________________________________________________________________________________________________________________________ Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Direct HDL assay is used for the quantitation of high-density lipoprotein cholesterol levels in human serum or plasma. Low Direct HDL measurements are used in the diagnosis and treatment of coronary artery disease.
(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) (Optional Format 1-2-96)
OR
Over-The-Counter Use
(Division Sign-Off)
Division of Clinical Laboratory Devices
K941224
510(k) Number
0000007