The Bayer Liquid Cardiac Markers 1, 2, 3 are assayed control materials for in vitro diagnostic use to monitor the precision and accuracy of immunochemical mass measurement test procedures for the ADVIA Centaur® andACS:180® Systems.

Device Description

The Bayer Liquid Cardiac Markers 1, 2, 3 are three separate levels of quality control material prepared from human serum with recombinant human CK-MB, human proteins, Digitoxin, Myoglobin, Troponin-I and Homocysteine.

AI/ML Overview

This document is a 510(k) summary for the Bayer Liquid Cardiac Markers 1, 2, 3, which are quality control materials. The purpose of this submission is to demonstrate substantial equivalence to a predicate device, not to present a study proving the device meets specific performance criteria in terms of diagnostic accuracy or impact on human health.

Therefore, much of the requested information regarding acceptance criteria, study design, expert involvement, and comparative effectiveness is not applicable to this type of submission for a quality control material.

Here's an breakdown of the relevant available information and why other sections are not applicable:

A table of acceptance criteria and the reported device performance
- Not applicable in the context of this 510(k) summary. This document does not detail specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy) for a diagnostic device. It is for a quality control material, whose "performance" is based on its ability to monitor the precision and accuracy of other immunochemical mass measurement test procedures. While the device itself would likely have internal specifications for its constituents and stability, these are not typically presented as "acceptance criteria" in a 510(k) summary for a control material. The submission states the device's "performance" is identical in intended use and fundamental scientific technology to the predicate device.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable in the context of this 510(k) summary. This document does not describe a clinical study with a test set of patient samples. The "test" for a quality control material focuses on its manufacturing specifications, stability, and its ability to produce expected results on the targeted diagnostic systems.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable in the context of this 510(k) summary. There is no "ground truth" to establish in the sense of patient diagnosis for a quality control material.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable in the context of this 510(k) summary. No patient-based test set requiring adjudication is described.
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 in the context of this 510(k) summary. This is not an AI/CAD device, nor is it a diagnostic device that requires human interpretation. It is a quality control material.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable in the context of this 510(k) summary. This is not an algorithm-based device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the context of this 510(k) summary. There is no "ground truth" relating to patient diagnosis for a quality control material. The "ground truth" for a control material would be its known assayed values and its ability to consistently fall within specified ranges.
The sample size for the training set
- Not applicable in the context of this 510(k) summary. This is not a machine learning or AI device that requires a training set.
How the ground truth for the training set was established
- Not applicable in the context of this 510(k) summary. This is not a machine learning or AI device.

Information relevant to the submission as a quality control material:

Device Name: Bayer Liquid Cardiac Markers 1, 2, 3
Intended Use: Assayed control materials for in vitro diagnostic use to monitor the precision and accuracy of immunochemical mass measurement test procedures for the ADVIA Centaur® and ACS:180® Systems.
Predicate Device: Liquid Cardiac Markers 1,2,3 (Premarket Notification Number: K960246)
Key Statement for Equivalence: "The Bayer Liquid Cardiac Markers 1, 2, and 3 are identical in intended use and fundamental scientific technology as the previously cleared Liquid Cardiac Markers 1,2, 3. The only difference in these controls is the addition of one new analyte, Homocysteine."

Conclusion:

This 510(k) submission for the Bayer Liquid Cardiac Markers 1, 2, 3 focuses on demonstrating substantial equivalence to a previously cleared quality control material. It does not present a clinical study with acceptance criteria related to diagnostic performance, patient outcomes, or human reader effectiveness. The "study" referenced implicitly is the demonstration that the new device (with the addition of Homocysteine) maintains the same fundamental scientific technology and intended use as the predicate device. The performance of the device is assessed through the lens of its suitability as a control material, not as a diagnostic tool itself.

Summary

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JAN 2 4 2003

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Business Group Diagnostics

Baver Cornoration 511 Benedict Avenue Tarrytown, NY 10591-5 Phone: 914 631-8000 Fax: 914 524-2132 http://www.baverdiag.com

Summary of Safety and Effectiveness

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.

KO30102 The assigned 510(k) Number is:

1. Submitter's Name and Address

Bayer HealthCare LLC Diagnostics Division 511 Benedict Avenue Tarrytown, NY 10591

Contact Person: Kenneth T. Edds, Ph.D. Telephone: 914-524-2446 Fax: 914-524-2500 e-mail: ken.edds.b@bayer.com

Establishment Registration Number: 2432235

1. Device Name: Proprietary/Trade Name Common Name: Classification Name: Classification: Regulation Number: Panel: Product Code:
  Liquid Cardiac Markers 1,2,3 Bayer Liquid Cardiac Markers 1,2,3 Quality Control Material Enzyme Controls (assayed and unassayed) Class I 21 CFR 862.1660 Chemistry (75) JJT
1. Predicate Device:
  Liquid Cardiac Markers 1,2,3 Premarket Notification Number: K960246

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4. Device Description:

5. Intended Use:

The Bayer Liquid Cardiac Markers 1, 2, and 3 are assayed control materials for in vitro diagnostic use to monitor the precision and accuracy of immunochemical mass measurement test procedures for the ADVIA Centaur® andACS:180® Systems.

6. Substantial Equivalence:

The Bayer Liquid Cardiac Markers 1, 2, and 3 are identical in intended use and fundamental scientific technology as the previously cleared Liquid Cardiac Markers 1,2, 3. The only difference in these controls is the addition of one new analyte, Homocysteine.

As with the predicate device, the control material is liquid and requires no further treatment before use. These controls are only for use on the Bayer ADVIA Centaur® and ACS:180® Systems.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 2 4 2003

Kenneth T. Edds, Ph.D. Manager, Regulatory Affairs Bayer Corporation Bayer HealthCare LLC 511 Benedict Avenue Tarrytown, NY 10591

Re: K030102

Trade/Device Name: Bayer Liquid Cardiac Makers 1, 2, 3 Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (Assayed and Unassayed) Regulatory Class: Class I Product Code: JJT Dated: January 10, 2003 Received: January 10, 2003

Dear Dr. Edds:

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 (OS) regulation (21 CFR Part 820).

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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 (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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K030102 510(k) Number (if known):_

Device Name: Bayer Liquid Cardiac Markers 1, 2, 3

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use OR

(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

(Division Sign-Off)
Division of Clinical
for Cooper
510(k) Number K030102

Regulation Number and Section

§ 862.1660 Quality control material (assayed and unassayed).

(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.