This in vitro method is intended to quantitatively measure HDL Cholesterol in human serum and plasma on the Bayer ADVIA® IMS systems. Measurements of HDL Cholesterol are used in assessing cardiovascular risk.

The Bayer ADV/A IMS Direct HDL Cholesterol (D-HDL) method is for in vitro diagnostic use to measure HDL Cholesterol in human serum and plasma. Such measurements are used in the risk assessment of cardiovascular diseases.

Device Description

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AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Direct HDL Cholesterol Method for ADVIA® Modular System (IMS), based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance (ADVIA IMS)
Imprecision
Level ~37 mg/dL	Total CV (%) = 3.3
Level ~55 mg/dL	Total CV (%) = 1.9
Level ~83 mg/dL	Total CV (%) = 1.8
Correlation
Regression Slope	0.986
Intercept	1.16
R-value	0.988
Syx (mg/dL)	2.29
Analytical Range	7 to 90 mg/dL

Note: The document does not explicitly state numerical "acceptance criteria" values (e.g., "CV must be < X%"). Instead, it presents the performance of the new device (ADVIA IMS) and compares it to a legally marketed predicate device (ADVIA 1650). The implicit acceptance criterion is that the new device's performance is comparable to or better than the predicate device. For the correlation study, the strong R-value, a slope near 1, and an intercept near 0, along with a low Syx, suggest good agreement. The provided table includes the performance of the predicate device (ADVIA 1650) for comparison.

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: 100 specimens for the correlation study (serum).
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). However, it's typically assumed to be a controlled laboratory study conducted to support regulatory submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is a quantitative assay, not an interpretive imaging or diagnostic device requiring expert consensus for ground truth. The "ground truth" is established by the comparative system (ADVIA 1650) which is a legally marketed device for the same measurement, or by a reference method which is not explicitly stated as distinct from the predicate device.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as this is a quantitative analytical measurement, not a subjective interpretation requiring adjudication.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is an in vitro diagnostic (IVD) assay for measuring a biomarker (HDL Cholesterol), not an AI-powered diagnostic imaging tool or a system involving human interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, this is a standalone device performance study. The measurements are performed by the ADVIA IMS system without human interpretive input for the result generation. Human operators would load samples and review results, but the analytical measurement itself is automated.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the correlation study is the measurements obtained from the predicate device, ADVIA 1650. For an IVD, the standard method for establishing accuracy (or substantial equivalence in this context) is comparison to a legally marketed predicate device or a recognized reference method.
The sample size for the training set:
- Not applicable in the context of this 510(k) submission. This device is a chemical assay, not a machine learning or AI model that requires a distinct "training set" in the computational sense. The development of the assay itself would involve optimization and calibration, but not a "training set" like an AI algorithm.
How the ground truth for the training set was established:
- Not applicable, as there isn't a "training set" in the AI sense. The development and calibration of the assay would rely on established analytical chemistry principles and reference materials, but this distinction isn't made in the document.

Summary

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MAY 2 6 2005

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Direct HDL Cholesterol Method for ADVIA® Modular System (IMS) ™

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.

The assigned 510(k) number is: Koso6 3 2

1. Intended Use

Predicate Device 2.

Product Name	Reagent Part #	Calibrator Part #
Bayer ADVIA 1650	08058065	00309530
Direct HDL Cholesterol		(B03-4763-01)

Device / Method 3.

Product Name	Reagent Part #	Calibrator Part #
ADVIA IMS	07986694	00309530
Direct HDL Cholesterol		(B03-4763-01)

Performance 4.

A. Imprecision

ADVIA IMS	ADVIA 1650
Level mg/dL	Total CV (%)	Level mg/dL	Total CV(%)
37.04	3.3	36.15	2.6
54.84	1.9	55.00	1.9
82.55	1.8	76.92	1.9

C. Correlation (Y=ADVIA IMS, X = Comparison system)

Specimen type	ComparisonSystem (X)	N	RegressionEquation	Syxmg/dL	R	IMS SampleRangemg/dL
Serum	ADVIA 1650	100	$Y=0.986X+1.16$	2.29	0.988	15 to 88

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D. Interfering Substances

InterferingSubstance	Interfering Sub.Conc. (mg/dL)	HDL CholesterolConcentration(mg/dL)	Effect(% change)
Bilirubin(unconjugated)	30	44.3	-1.1%
Bilirubin(conjugated)	20	46.5	-7.3%
Hemoglobin	500	46.2	-9.5%
Lipids (Intralipid)	1000	45.0	-4.9%

E. Analytical Range

7 to 90 mg/dL.

Re h 3/4/2005

Date

Andres Holle Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York, 10591 - 5097

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The text is in all capital letters and is positioned around the upper half of the circular logo.

Public Health Service

Food and Drug Administrati 2098 Gaither Road Rockville MD 20850

MAY 2 6 2005

Mr. Andres Holle Manager, Regulatory Affairs Bayer HealthCare Diagnostics Division 511 Benedict Avenue Tarrytown, NY 10591

Re: K050632

Trade/Device Name: Direct HDL Cholesterol for the ADVIA IMS Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein test system Regulatory Class: Class I Product Code: LBS Dated: March 4, 2005 Received: March 9, 2005

Dear Mr. Holle:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, 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).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device. or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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. Benem

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

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Indications for Use

KOS 063 2 510(k) Number:

Device Name: Direct HDL Cholesterol for the ADVIA IMS

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Ruta Chester

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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KO50632 510(k)

Regulation Number and Section

§ 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.