BAYER ADVIA IMS PSA CALIBRATOR AND ADVIA IMS CPSA CALIBRATORS

K061139 · Bayer Healthcare, LLC · JIT · Jul 6, 2006 · Clinical Chemistry

Device Facts

• Record ID: K061139
• Device Name: BAYER ADVIA IMS PSA CALIBRATOR AND ADVIA IMS CPSA CALIBRATORS
• Applicant: Bayer Healthcare, LLC
• Product Code: JIT · Clinical Chemistry
• Decision Date: Jul 6, 2006
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

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.

Device Story

The ADVIA® IMS PSA and cPSA Calibrators are liquid, bovine serum-based products used to calibrate quantitative PSA and cPSA assays on the ADVIA® IMS system. The PSA calibrator consists of six levels (0, 2, 10, 25, 50, and 100 ng/mL). The cPSA calibrator values are lot-specific. These calibrators are used in clinical laboratory settings by trained personnel to ensure the accuracy of PSA measurements, which are used in the clinical management of prostate conditions.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Bovine serum-based liquid calibrators. PSA levels: 0, 2, 10, 25, 50, 100 ng/mL. cPSA levels: lot-specific. Storage: 2-8°C (PSA); <= -10°C (cPSA). Traceable to Stanford University PSA reference material.

Indications for Use

Indicated for use as calibrators for quantitative PSA and complexed PSA (cPSA) assays on the ADVIA® IMS system. Prescription use only.

Regulatory Classification

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.)

Special Controls

*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.

Predicate Devices

• Lipoprotein Calibrator (K051619)

Submission Summary (Full Text)

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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: [phone] Fax: [phone] 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 [phone]. 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 [phone] or [phone] 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