For in vitro diagnostic use to monitor the precision and the accuracy of the assayed, quantitative complexed PSA assays on the ADVIA® IMS and Bayer Immuno1® systems.

Device Description

The Bayer ADVIA® IMS cPSA Controls are bovine serum based with non-serum constituents added. The analytes currently in the control material are: cPSA

AI/ML Overview

This document is a 510(k) summary for the ADVIA® IMS cPSA Control, a quality control material. It describes the device, its intended use, and its substantial equivalence to a predicate device. As a quality control material used to monitor the performance of other assays, the acceptance criteria and study design are different from those for diagnostic devices that detect a disease. This document does not describe a clinical study in the typical sense with patient data, expert readers, or AI performance metrics.

Here's an analysis of the provided text based on the requested information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in the context of performance specifications for the ADVIA® IMS cPSA Control itself. Instead, it describes its intended use as a quality control material "to monitor the precision and the accuracy of the assayed, quantitative complexed PSA assays on the ADVIA® IMS and Bayer Immuno1® systems."

The "reported device performance" of the ADVIA® IMS cPSA Control is implied by its function as a control. The key performance characteristics for such a control material would typically be its assigned values (which establish accuracy) and its stability (which ensures its continued utility for precision monitoring over time). However, these specific values or stability data are not provided in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable and not provided. The device is a quality control material, not a diagnostic device that processes patient samples or generates diagnostic data. There is no "test set" in the sense of patient data.

3. 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)

This information is not applicable and not provided. As explained above, there is no "test set" of patient data requiring expert-established ground truth. The "ground truth" for a quality control material would be its manufacturing specifications and assigned analyte values, determined through laboratory methods, not expert consensus on patient cases.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided for the same reasons as above.

5. 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

This information is not applicable and not provided. This device is a quality control material, not an AI-powered diagnostic tool, and therefore no MRMC study or AI-related effectiveness study was performed or is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable and not provided. This device is a quality control material, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For a quality control material, the "ground truth" refers to its assigned analyte values (in this case, cPSA concentration) and its manufacturing specifications. These are established through rigorous laboratory testing during the development and manufacturing process, comparing it against reference materials and methods. The document does not detail how these specific values were established but implies they are part of the product specifications.

8. The sample size for the training set

This information is not applicable and not provided. This device is a quality control material, not a machine learning algorithm, and therefore has no "training set."

9. How the ground truth for the training set was established

This information is not applicable and not provided for the same reasons as above.

Summary

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JUL - 6 2006

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.

k 061137 The assigned 510(k) Number is:

Submitter's Name and Address

Bayer Healthcare LLC 511 Benedict Avenue Tarrytown, NY 10591 Establishment Registration Number: 2432235

Contact Person: Andres Holle Telephone: 914-524-3494 Fax: 914-524-2500 e-mail: andres.holle.b(@bayer.com

Contract Manufacturer

Fisher Diagnostics 8365 Valley Pike Middletown, VA 22645-0307 Establishment Registration: 1181121

Device Name:
Proprietary/Trade Name:
Common Name:
Classification Name:
Classification:
Regulation Number:
Panel:
Product Code:

ADVIA® IMS cPSA Control ADVIA® IMS cPSA Control Assayed Quality Control Material Assayed Quality Control Material Class I 21 CFR 862.1660 Chemistry (75) JJY

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Predicate Device:

Bayer Special Chemistry Controls Premarket Notification Number: K033379

Device Description:

The Bayer ADVIA® IMS cPSA Controls are bovine serum based with non-serum constituents added.

The analytes currently in the control material are: cPSA

Intended Use:

For in vitro diagnostic use to monitor the precision and the accuracy of the assayed, quantitative complexed PSA assays on the ADVIA® IMS and Bayer Immuno1® systems.

Substantial Equivalence:

The ADVIA® IMS cPSA Controls are substantially equivalent in intended use, storage and handling, stability, source material, and instructions for use as the previously cleared Bayer Special Chemistry Controls.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" written around the edge. In the center of the seal is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL - 6 2006

Bayer Healthcare, LLC c/o Mr. Andres Holle Manager, Regulatory Affairs 511 Benedict Ave. Tarrytown, NY 10591-5097

Re: K061137

Trade/Device Name: ADVIA® IMS cPSA Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (Assayed and Unassayed) Regulatory Class: Class I, reserved Product Code: JJY Dated: April 17, 2006 Received: April 25, 2006

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 cnactment 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 affècting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDAs 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 Acts requirements. including, but not limited to: registration and listing (21 CER Part 807). labeling (21 CFR Part 801): good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

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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 wour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0484. Also, please note the regulation ventitled, "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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html (

Sincerely yours.

Robert R. Bochel

Robert L. Becker, Jr., M.D., PH.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: ADVIA® IMS cPSA Control

Indications for Use:

For in vitro diagnostic use to monitor the precision and the accuracy of the assayed, quantitative complexed PSA assays on the ADVIA® IMS and Bayer Immunol® systems.

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)

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Mana In Chan

Division Sign-Off

Office of In Vitto Diagnostic Device Evaluation and Safety

510(k) K061137

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.