ADVIA IMS CPSA CONTROL

K061137 · Bayer Healthcare, LLC · JJY · Jul 6, 2006 · Clinical Chemistry

Device Facts

• Record ID: K061137
• Device Name: ADVIA IMS CPSA CONTROL
• Applicant: Bayer Healthcare, LLC
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jul 6, 2006
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

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. For prescription use only.

Device Story

Bayer ADVIA® IMS cPSA Controls are bovine serum-based quality control materials containing cPSA analyte; used to monitor precision and accuracy of quantitative cPSA assays on ADVIA® IMS and Bayer Immuno1® systems. Kit includes three levels: Level 1 at clinically significant decision point; Level 3 at upper analytical range; Level 2 at intermediate level. Used by laboratory personnel in clinical settings to verify assay performance. Traceable to Stanford University PSA reference material (90:10 PSA-α₁-antichymotrypsin to free PSA ratio).

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Bovine serum-based matrix with added cPSA analyte. Liquid, ready-to-use format. Three-level concentration design. Traceable to Stanford University PSA reference material (90:10 molar ratio of PSA-ACT to free PSA). Storage: <= -10°C (unopened), 2-8°C (opened).

Indications for Use

Indicated for in vitro diagnostic use to monitor the precision and accuracy of quantitative complexed PSA assays on ADVIA IMS and Bayer Immuno1 systems.

Regulatory Classification

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.

Predicate Devices

• Bayer Special Chemistry Controls (k033379)

Submission Summary (Full Text)

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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: [phone] Fax: [phone] e-mail: andres.holle.b(@bayer.com

#### Contract Manufacturer

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

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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

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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 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 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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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 [phone]. 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 [phone] or [phone] 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