(49 days)
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.
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 assay 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.
Here's an analysis of the provided text, outlining the acceptance criteria and the study proving the device meets them:
Device: Cholesterol Assay (Abbott Laboratories)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Correlation Coefficient | 0.9929 (against Boehringer Mannheim® Cholesterol assay on Hitachi® 717 Analyzer) |
| Slope | 1.016 (against Boehringer Mannheim® Cholesterol assay on Hitachi® 717 Analyzer) |
| Y-intercept | 0.933 mg/dL (against Boehringer Mannheim® Cholesterol assay on Hitachi® 717 Analyzer) |
| Total %CV (Level 1/Panel 101 control) | 0.8% |
| Total %CV (Level 2/Panel 102 control) | 1.6% |
| Linearity Range | Up to 705.3 mg/dL |
| Limit of Quantitation (Sensitivity) | 4.4 mg/dL |
| "Similar" Performance Characteristics (to predicate device) | Achieved, as evidenced by correlation, slope, and Y-intercept. |
| "Similar" Clinical Results (to predicate device) | Stated as achieved. |
| "Similar" Assay Range (to predicate device) | Stated as achieved. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size used for the test set in terms of the number of patient samples. It mentions "Comparative performance studies" were conducted and "Precision studies were conducted using two levels of control material."
- Sample Size for Comparative Performance (Method Comparison): Not explicitly stated in terms of number of patient samples.
- Sample Size for Precision Studies: Two levels of control material were used.
- Data Provenance: The document does not specify the country of origin. It indicates the studies were conducted using the AEROSET™ System and validated against the Abell-Kendall reference method in a CDC-Certified Cholesterol Reference Method Laboratory Network (CRMLN). This implies these were likely prospective studies specifically designed for device validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not applicable in the context of this in vitro diagnostic device for cholesterol. The "ground truth" for cholesterol measurement is established by reference methods and validated analytical techniques, not by expert consensus on interpretation.
- The Cholesterol assay was "validated against the Abell-Kendall reference method in a CDC-Certified Cholesterol Reference Method Laboratory Network (CRMLN)." The Abell-Kendall method is a definitive chemical measurement, and the CRMLN provides certified reference materials and methods.
4. Adjudication Method for the Test Set
Not applicable. The determination of cholesterol levels is a quantitative analytical measurement, not subject to subjective interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for imaging or diagnostic devices that require human interpretation and aims to assess the impact of AI assistance on human reader performance. This device is an in vitro diagnostic assay for direct quantitative measurement.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the primary performance evaluation presented is a standalone performance of the Cholesterol assay device. The comparison is against a predicate device and a reference method, indicating the device itself, running independently, produced the reported results. There is no mention of human-in-the-loop performance given the nature of the assay.
7. The Type of Ground Truth Used
The ground truth was established using:
- Reference Method: The Abell-Kendall reference method, performed in a CDC-Certified Cholesterol Reference Method Laboratory Network (CRMLN). This is a highly robust and authoritative ground truth for cholesterol quantitation.
- Predicate Device: The Boehringer Mannheim® Cholesterol assay on the Hitachi® 717 Analyzer, which serves as a comparison benchmark for substantial equivalence.
8. The Sample Size for the Training Set
The document does not provide information about a "training set" as this device is an in vitro diagnostic assay, not an AI/machine learning algorithm that typically requires a distinct training and test set. The described studies are validation or verification studies for the analytical performance of the assay.
9. How the Ground Truth for the Training Set Was Established
As noted above, the concept of a "training set" and its associated ground truth is not applicable to this type of in vitro diagnostic assay. Performance is assessed through direct comparison to established reference methods and predicate devices.
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' 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
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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
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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
00000000
§ 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.