ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3

K030102 · Bayer Healthcare, LLC · JJT · Jan 24, 2003 · Clinical Chemistry

Device Facts

• Record ID: K030102
• Device Name: ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3
• Applicant: Bayer Healthcare, LLC
• Product Code: JJT · Clinical Chemistry
• Decision Date: Jan 24, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for 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.

Device Story

Bayer Liquid Cardiac Markers 1, 2, 3 are liquid quality control materials derived from human serum; supplemented with recombinant human CK-MB, human proteins, Digitoxin, Myoglobin, Troponin-I, and Homocysteine. Used in clinical laboratory settings to monitor precision and accuracy of immunochemical mass measurement assays on Bayer ADVIA Centaur and ACS:180 systems. Product is liquid, ready-to-use, requiring no preparation. Healthcare providers use control results to verify system performance before reporting patient test results. Benefits include ensuring reliability of cardiac marker testing, aiding in accurate clinical diagnosis and management of cardiac conditions.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Liquid control material derived from human serum. Contains recombinant human CK-MB, human proteins, Digitoxin, Myoglobin, Troponin-I, and Homocysteine. Designed for use on ADVIA Centaur and ACS:180 systems. No specific materials standards or software algorithms described.

Indications for Use

Indicated for use as assayed quality control materials to monitor precision and accuracy of immunochemical mass measurement test procedures on Bayer ADVIA Centaur and ACS:180 systems. No specific patient population indicated as this is an in vitro diagnostic control product.

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

• Liquid Cardiac Markers 1,2,3 (K960246)

Submission Summary (Full Text)

{0}------------------------------------------------

# JAN 2 4 2003

Image /page/0/Picture/1 description: The image shows the Bayer logo. The word "Bayer" is written in a bold, sans-serif font. To the right of the word is a circle with the word "Bayer" written vertically inside of it. The letters are arranged in a cross shape.

#### Business Group Diagnostics

Baver Cornoration 511 Benedict Avenue Tarrytown, NY 10591-5 Phone: [phone] Fax: [phone] 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: [phone] Fax: [phone] e-mail: [e-mail]

Establishment Registration Number: 2432235

- 2. 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

- 3. Predicate Device:
Liquid Cardiac Markers 1,2,3 Premarket Notification Number: K960246

{1}------------------------------------------------

#### 4. 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.

#### 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.

{2}------------------------------------------------

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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract eagle or bird with three curved lines forming its body and wings.

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).

{3}------------------------------------------------

#### 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 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 [phone]. 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 [phone] or [phone] 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

{4}------------------------------------------------

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

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

### Indications for Use:

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.

## (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