(49 days)
Not Found
No
The device description details a standard enzymatic chemical reaction for measuring cholesterol. There is no mention of AI, ML, image processing, or any data-driven algorithms beyond basic statistical analysis of performance.
No.
This device is an in vitro diagnostic assay used for the quantitative determination of cholesterol in human serum or plasma, which is for diagnostic purposes, not for treating or preventing disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders." This directly indicates its role in diagnosis.
No
The device description clearly outlines a chemical assay process involving enzymatic reactions and the formation of a chromophore, indicating a physical in vitro diagnostic kit, 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 cholesterol in human serum or plasma and that these measurements are used in the diagnosis and treatment of disorders. This aligns directly with the definition of an in vitro diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The "Device Description" further clarifies that it is an "in vitro diagnostic assay" for the quantitative determination of cholesterol in human serum or plasma.
- Input Imaging Modality and Anatomical Site: The "Not Applicable" entries for these sections, along with the description of using serum or plasma, reinforce that the device operates on biological samples outside of the body.
The information provided clearly indicates that this device is designed to perform tests on biological samples in vitro (outside the living body) for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Cholesterol assay is used for the quantitation of cholesterol in human serum or plasma. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
Product codes (comma separated list FDA assigned to the subject device)
75CHH
Device Description
Cholesterol is an in vitro diagnostic assay for the quantitative determination of cholesterol in human serum or plasma. The Cholesterol assay is a clinical chemistry assav in which cholesterol esters are enzymatically hydrolyzed by cholesterol esterase to cholesterol and free fatty acids. Free cholesterol, including that originally present, is then oxidized by cholesterol oxidase to cholest-4-en-3-one and hydrogen peroxide. The hydrogen peroxide combines with Hydroxybenzoic Acid and 4-aminoantipyrine to form a chromophore (quinoneimine dye) which can be measured.
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. The Cholesterol assay method comparison vielded acceptable correlation with the Boehringer Mannheim Cholesterol assay on the Hitachi 717 Analyzer. The correlation coefficient = 0.9929, slope = 1.016, and Y-intercept = 0.933 mg/dL. The Cholesterol assay on the AEROSET was validated against the Abell-Kendall reference method in a CDC-Certified Cholesterol Reference Method Laboratory Network (CRMLN). Precision studies were conducted using the Cholesterol assay. Within-run, between-run, and between-day studies were performed using two levels of control material. The total %CV for Level 1/Panel 101 control is is 0.8% and Level 2/Panel 102 is 1.6%. The Cholesterol assay is linear up to 705.3 mg/dL. The limit of quantitation (sensitivity) of the Cholesterol assay is 4.4 mg/dL. These data demonstrate that the performance of the Cholesterol assay is substantially equivalent to the performance of the Boehringer Mannheim Cholesterol assay on the Hitachi 717 Analyzer.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
correlation coefficient = 0.9929, slope = 1.016, and Y-intercept = 0.933 mg/dL.
The total %CV for Level 1/Panel 101 control is is 0.8% and Level 2/Panel 102 is 1.6%.
The Cholesterol assay is linear up to 705.3 mg/dL.
The limit of quantitation (sensitivity) of the Cholesterol assay is 4.4 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
§ 862.1175 Cholesterol (total) test system.
(a)
Identification. A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.(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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JUN 2 9 1998
... ..........................................................................................................................................................................
' هتي الحقيق
Section II
510(k) Summary
Cholesterol 510(k)
May 8, 1998
Chol510k.lwp
Section II
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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 Regulatory Affairs (972) 518-6062 Fax (972) 753-3367
| Date of Preparation of this Summary: | May 8, 1998 |
|---|---|
| Device Trade or Proprietary Name: | Chol |
| Device Common/Usual Name or Classification Name: | Cholesterol |
| Classification Number/Class: | 75CHH/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:
Cholesterol is an in vitro diagnostic assay for the quantitative determination of cholesterol in human serum or plasma. The Cholesterol assay is a clinical chemistry assav in which cholesterol esters are enzymatically hydrolyzed by cholesterol esterase to cholesterol and free fatty acids. Free cholesterol, including that originally present, is then oxidized by cholesterol oxidase to cholest-4-en-3-one and hydrogen peroxide. The hydrogen peroxide combines with Hydroxybenzoic Acid and 4-aminoantipyrine to form a chromophore (quinoneimine dye) which can be measured.
Cholesterol 510(k) May 8, 1998 Chol510k.lwp
Section II Page 1
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Substantial Equivalence:
The Cholesterol assay is substantially equivalent to the Boehringer Mannheim® Cholesterol assay on the Hitachi® 717 Analyzer (K854298).
These assays vield similar Performance Characteristics.
Similarities:
- u Both assays are in vitro clinical chemistry methods.
- Both assays can be used for the quantitative determination of cholesterol. .
- Both assays vield similar clinical results. .
- Both assays have a similar assay range. .
Intended Use:
The Cholesterol assay is used for the quantitation of cholesterol in human serum or plasma.
Performance Characteristics:
Comparative performance studies were conducted using the AEROSET™ System. The Cholesterol assay method comparison vielded acceptable correlation with the Boehringer Mannheim Cholesterol assay on the Hitachi 717 Analyzer. The correlation coefficient = 0.9929, slope = 1.016, and Y-intercept = 0.933 mg/dL. The Cholesterol assay on the AEROSET was validated against the Abell-Kendall reference method in a CDC-Certified Cholesterol Reference Method Laboratory Network (CRMLN). A copy of the CRMLN Certificate of Traceability is included in Section III.G. Precision studies were conducted using the Cholesterol assay. Within-run, between-run, and between-day studies were performed using two levels of control material. The total %CV for Level 1/Panel 101 control is is 0.8% and Level 2/Panel 102 is 1.6%. The Cholesterol assay is linear up to 705.3 mg/dL. The limit of quantitation (sensitivity) of the Cholesterol assay is 4.4 mg/dL. These data demonstrate that the performance of the Cholesterol assay is substantially equivalent to the performance of the Boehringer Mannheim Cholesterol assay on the Hitachi 717 Analyzer.
Cholesterol 510(k) May 8, 1998 CholS10k.lwp
Section II Page 2
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Conclusion:
The Cholesterol assay is substantially equivalent to the Boehringer Mannheim Cholesterol assay on the Hitachi 717 Analyzer as demonstrated by results obtained in the studies.
Cholesterol 510(k) May 8, 1998
Chol510k.lwp
Section II
Page 3
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three wavy lines representing the department's mission to promote health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 2 9 1998
Mark Littlefield Section Manager, Regulatory Affairs Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038
K981652 Re: Cholesterol Requlatory Class: I Product Code: CHH Dated: May 8, 1998 Received: May 11, 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 marice is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate able beated in tho 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 se basicons 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 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 regulations.
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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 "dsmo@fdadr.cdrh.fda.gov".
Sincerely yours,
Steven Autman
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
6
510(k) Number (if known):
Cholesterol Device Name:
Indications For Use:
The Cholesterol assay is used for the quantitation of cholesterol in human serum or plasma. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use Prescription Use V OR (Per 21 CFR 801.109) (Optional Format 1-2-96)
Carol C Benson for Alford Montgomery
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K981652
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