For in vitro diagnostic use in the calibration of quantitative PSA assays on the ADVIA® IMS system.
For in vitro diagnostic use in the calibration of quantitative complexed PSA assays on the ADVIA® IMS system.

Device Description

The Bayer ADVIA® IMS PSA Calibrators and ADVIA® IMS cPSA Calibrators are for values of calibrator material prepared in bovine serum with non-serum constituents added.
The analytes currently in the calibrator material are: PSA in the ADVIA® IMS PSA Calibrator cPSA in ADVIA® IMS cPSA Calibrator

AI/ML Overview

This document is a 510(k) summary for the ADVIA® IMS PSA Calibrator and ADVIA® IMS cPSA Calibrator. It establishes substantial equivalence to a predicate device but does not describe a study that involves performance acceptance criteria against which devices are measured. This type of device (calibrator) would typically undergo studies related to its stability, traceability, and commutability, rather than efficacy studies with clinical endpoints.

Therefore, many of the requested elements for describing an acceptance criteria study are not applicable to the information provided in this document.

Here's a breakdown of the applicable information:

A table of acceptance criteria and the reported device performance:
- Not applicable. This document does not present specific performance acceptance criteria for the calibrator itself, nor does it report performance against such criteria. The 510(k) submission focuses on substantial equivalence to a predicate calibrator and its intended use for calibration. Performance of the calibrator would be assessed through its ability to enable accurate and precise measurements by the ADVIA® IMS system when assaying patient samples, which is not detailed here.
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not applicable. There is no "test set" in the context of device performance evaluation described in this document.
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. Ground truth establishment by experts is generally not relevant for calibrator devices.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable.
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 is not an AI-assisted diagnostic device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm-based device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable.
The sample size for the training set:
- Not applicable. This is not an AI/machine learning device requiring a training set.
How the ground truth for the training set was established:
- Not applicable.

Summary of Relevant Information from the Provided Text:

Device Type: In vitro diagnostic calibrator material.
Intended Use: For in vitro diagnostic use in the calibration of quantitative PSA and complexed PSA assays on the ADVIA® IMS system.
Substantial Equivalence: The device is deemed substantially equivalent in intended use, storage and handling, stability, source material, and instructions for use to the previously cleared Bayer Lipoprotein Calibrators (K051619). This is the primary "proof" for this type of device according to the 510(k) process – demonstrating it is as safe and effective as a legally marketed predicate device.
Device Description: Prepared in bovine serum with non-serum constituents added. The analytes are PSA and cPSA.

Summary

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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.

JUL - 6 2006

Rob 1139 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 PSA Calibrator and ADVIA® IMS cPSA Calibrator ADVIA® IMS PSA Calibrator and ADVIA® IMS cPSA Calibrator Calibrator Material Calibrator Class II 21 CFR 862,1150 Chemistry (75) JIT

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Predicate Device:

Lipoprotein Calibrator Premarket Notification Number: K051619

Device Description:

The Bayer ADVIA® IMS PSA Calibrators and ADVIA® IMS cPSA Calibrators are for values of calibrator material prepared in bovine serum with non-serum constituents added.

The analytes currently in the calibrator material are: PSA in the ADVIA® IMS PSA Calibrator cPSA in ADVIA® IMS cPSA Calibrator

Intended Use:

For in vitro diagnostic use in the calibration of quantitative PSA assays on the ADVIA® IMS system.

For in vitro diagnostic use in the calibration of quantitative complexed PSA assays on the ADVIA® IMS system.

Substantial Equivalence:

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

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines. The logo is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 1 7 2006

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

Re: K061139

Trade/Device Name: ADVIA® IMS PSA Calibrator and ADVIA® IMS cPSA Calibrator Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: April 17, 2006 Received: April 25, 2006

Dear Mr. Holle:

This letter corrects our substantially equivalent letter of July 6, 2006.

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 (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 additional controls. Existing major regulations affecting 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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your devices comply 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 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.

This letter will allow you to continue marketing your devices as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0131. 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 (240) 276-3105 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html

Sincerely vours.

Robert F. Rockey

Robert L. Becker, Jr., M,D,. PhD 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 PSA Calibrator

Indications For Use:

For in vitro diagnostic use in the calibration of quantitative PSA assays on the ADVIA® IMS System.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

chon

onsion Sign-C

office of in Vitro Diagno Device Evaluation and Sa

510(k) K061139

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Indications for Use

510(k) Number (if known):

Device Name: ADVIA® IMS cPSA Calibrator

Indications for Use:

For in vitro diagnostic use in the calibration of quantitative complexed PSA assays on the ADVIA® IMS system.

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)

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Min Chin

Division Sign-Off

Office of In Vitto Diagnostic Device Evaluation and Safety

51000 K-6/1159

Regulation Number and Section

§ 862.1150 Calibrator.

(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.