(115 days)
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No
The device description outlines a standard in vitro diagnostic assay based on enzymatic reactions and color formation, with no mention of AI or ML. The performance studies focus on traditional analytical metrics like correlation, precision, and linearity.
No
Explanation: This device is an in vitro diagnostic assay used for the quantitative determination of LDL cholesterol levels. It is designed to aid in the diagnosis and treatment of conditions, but it does not directly treat or prevent a disease, injury, or condition in a patient. Therefore, it is not a therapeutic device.
Yes
The "Intended Use / Indications for Use" section explicitly states that "LDL measurements are used in the diagnosis and treatment of the pathogensis of arteriosclerosis and coronary artery disease."
No
The device description clearly describes a chemical assay that uses reagents and enzymatic reactions to measure LDL levels, which is a hardware-based in vitro diagnostic device, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "quantitation of low-density lipoprotein cholesterol levels in human serum or plasma." This involves testing a sample taken from the human body.
- Device Description: The description clearly states "LDL is an in vitro diagnostic assay".
- Mechanism: The description details a chemical reaction that occurs in vitro (outside the body) to measure the LDL levels in the sample.
These points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition.
N/A
Intended Use / Indications for Use
The LDL assay is used in the quantiation of low-density lipoprotein cholesterol levels in serum or plasma.
The LDL assay is used for the quantitation of low-density lipoprotein cholesterol levels in human serum or plasma. LDL measurements are used in the diagnosis and treatment of the pathogensis of arteriosclerosis and coronary artery disease.
Product codes
75JGJ, MRR
Device Description
LDL is an in vitro diagnostic assay for the quantitative determination of low-density lipoprotein cholesterol (LDL) in human serum or plasma. The detergent solubilizes only the non-LDL lipoprotein particles. The cholesterol released is consumed by cholesterol esterase and cholesterol oxidase in a non-color forming reaction. Another detergent solubilizes the remaining LDL particles and a chromogenic coupler allows for color formation. The enzyme reaction with LDL cholesterol in the presence of the coupler produces color which is proportional to the amount of LDL cholesterol present in the sample.
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
Comparative performance studies were conducted using the ALCYON™ Analyzer. The LDL assay method comparison yielded acceptable correlation with the Roche Cobas Mira Plus Automated Chemistry System LDL assay for serum. Precision studies were conducted using the LDL assay. Within-run, between-run, and between-day studies were performed using two levels of control material. The LDL assay is linear up to 600 mg/dL.
Key Metrics
correlation coefficient = 0.9546, slope = 0.984, and Y-intercept = 7.466 mg/dL. The total %CV for Level 1/Panel 141 control is 3.3% and Level 2/Panel 142 is 4.0%. The limit of quantititation (sensitivity) of the LDL assay is 1 mg/dL.
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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: | April 9, 1998 |
|---|---|
| Device Trade or Proprietary Name: | Direct LDL |
| Device Common/Usual Name or Classification Name: | LDL |
| Classification Number/Class: | 75JGJ/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.
X961303 The assigned 510(k) number is: __
Test Description:
LDL is an in vitro diagnostic assay for the quantitative determination of low-density lipoprotein cholesterol (LDL) in human serum or plasma. The detergent solubilizes only the non-LDL lipoprotein particles. The cholesterol released is consumed by cholesterol esterase and cholesterol oxidase in a non-color forming reaction. Another detergent solubilizes the remaining LDL particles and a chromogenic coupler allows for color formation. The enzyme reaction with LDL cholesterol in the presence of the coupler produces color which is proportional to the amount of LDL cholesterol present in the sample.
DI . 510/k) Anni 9, 1998 Section II Page 1
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Substantial Equivalence:
The LDL assay is substantially equivalent to the Roche Cobas Mira Automated
Chemistry assay.
Similarities:
- Both assays are in vitro clinical chemistry methods. .
- Both assays can be used for the quantitative determination of LDL. .
- Both assays yield similar clinical results. .
Differences:
- There is a difference between the assay range. .
- There is a difference between the assay principles. .
- There is a difference between reagent handling in that LDL is a two-reagent . kit and the Roche® Cobas Mira® Plus Automated Chemistry System LDL Cholesterol (Direct) assay is single-reagent kit.
Intended Use:
The LDL assay is used in the quantiation of low-density lipoprotein cholesterol levels in serum or plasma.
Performance Characteristics:
Comparative performance studies were conducted using the ALCYON™ Analyzer. The LDL assay method comparison yielded acceptable correlation with the Roche Cobas Mira Plus Automated Chemistry System LDL assay for serum. The correlation coefficient = 0.9546, slope = 0.984, and Y-intercept = 7.466 mg/dL. Precision studies were conducted using the LDL 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 3.3% and Level 2/Panel 142 is 4.0%. The LDL assay is linear up to 600 mg/dL. The limit of quantititation (sensitivity) of the LDL assay is 1 mg/dL. These data demonstrate that the performance of the LDL assay is
LDL 510(k) April 9, 1998 LDLE2.lwp
Section II Page 2
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981303
substantially equivalent to the performance of the Roche Cobas Mira Plus Automated Chemistry System LDL assay for serum.
Conclusion:
The LDL assay is substantially equivalent to the Roche Cobas Mira Plus Automated Chemistry System LDL assay as demonstrated by results obtained in the studies.
LDL 510(k) April 9, 1998
LDLE2.lwp Section II Page 3
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) of the United States. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
3 1698 AUG
Mark Littlefield Section Manager, Regulatory Affairs Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038
Re : K981303 LDL Requlatory Class: I Product Code: MRR Dated: July 2, 1998 Received: July 6, 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜੋ 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 requlation may result in requlatory 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 regulations.
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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 yitro 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 Gutman
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
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510(k) Number (if known): _ V 9 0 30 3
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The LDL assay is used for the quantitation of low-density lipoprotein cholesterol levels in human serum or plasma. LDL measurements are used in the diagnosis and treatment of the pathogensis of arteriosclerosis and 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) | |
| OR | Over-The-Counter Use _____ |
| (Optional Format 1-2-96) | |
| Division Sign-Off | |
| Division of Clinical Laboratory Devices | |
| 10(k) Number | r981303 |