ADVIA CENTAUR HOMOCYSTEINE ASSAY

K013406 · Bayer Diagnostics Corp. · LPS · Dec 18, 2001 · Clinical Chemistry

Device Facts

• Record ID: K013406
• Device Name: ADVIA CENTAUR HOMOCYSTEINE ASSAY
• Applicant: Bayer Diagnostics Corp.
• Product Code: LPS · Clinical Chemistry
• Decision Date: Dec 18, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1377
• Device Class: Class 2

Intended Use

For in vitro diagnostic use in the quantitative determination of total homocysteine (HCY) in serum or EDTA plasma using the ADVIA Centaur® System. This diagnostic test is designed to quantitatively measure HCY in serum or EDTA plasma. Such measurement can aid in the diagnosis and treatment of patients suspected of having homocysteinuria or hyperhomocysteinemia.

Device Story

The ADVIA Centaur HCY assay is a competitive immunoassay for the quantitative measurement of total homocysteine (HCY) in serum or EDTA plasma. The assay uses a four-reagent sequence: a reducing reagent (dithiothreitol) releases protein-bound HCY; the enzyme S-adenosylhomocysteine hydrolase converts free HCY to S-adenosylhomocysteine (SAH). SAH competes with a monoclonal anti-SAH antibody conjugated to an acridinium ester. Following incubation and washing, the chemiluminescence of the bound acridinium ester is measured. The signal is inversely proportional to the HCY concentration in the sample. The assay is performed on the ADVIA Centaur System in a clinical laboratory setting. Results are used by clinicians to assist in the diagnosis and treatment of patients with suspected homocysteinuria or hyperhomocysteinemia.

Clinical Evidence

Bench testing only. A method comparison study was conducted comparing the ADVIA Centaur HCY assay to the predicate IMx Homocysteine assay using 106 clinical samples. Linear regression analysis yielded a correlation coefficient (R) of 0.981, with the relationship defined as IMx = 0.98 (ADVIA Centaur) + 0.42 umol/L.

Technological Characteristics

Competitive immunoassay using chemiluminescence detection. Reagents include dithiothreitol for reduction and S-adenosylhomocysteine hydrolase for enzymatic conversion. Uses mouse monoclonal anti-SAH antibody-acridinium ester conjugate. Designed for use on the ADVIA Centaur System.

Indications for Use

Indicated for the quantitative measurement of total homocysteine in serum or EDTA plasma to aid in the diagnosis and treatment of patients suspected of having homocysteinuria or hyperhomocysteinemia.

Regulatory Classification

Identification

A urinary homocystine (nonquantitative) test system is a device intended to identify homocystine (an analogue of the amino acid cystine) in urine. The identification of urinary homocystine is used in the diagnosis and treatment of homocystinuria (homosystine in urine), a heritable metabolic disorder which may cause mental retardation.

Predicate Devices

• IMx Homocysteine (K992858)

Submission Summary (Full Text)

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DEC 1 82001

K013406

## Bayer Diagnostics ADVIA Centaur HCY Assay

# Section 2 - Summary of Safety and Effectiveness

- 1. Submitter Information Kenneth T. Edds, Ph.D. Contact Person: Bayer Diagnostic Corporation Address: 511 Benedict Ave. Tarrytown, N.Y. 10591 Phone: [phone] FAX: [phone] e-mail: [e-mail] Date Summary Prepared: 10/10/01 2. Device Information ADVIA Centaur Homocysteine (HCY) Assay Propriety Name: HCY assay Common Name: Classification Name: Urinary Homocysteine Assay Class: II 862.1377 CFR: Product Code: 75 LPS 3. Predicate Device Information IMx Homocysteine Name: Manufacturer: Manufactured by: Axis-Shield ASA Ulvenveien 87 N-0581 Oslo, Norway Manufactured for: Abbott Laboratories Abbott Park Road Abbott Park, Il. 60064 510(k) Number: K 992858

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#### 4. Device Description

The ADVIA Centaur HCY assay is a competitive immunoassay using direct, The rib vir connecessent technology. It is intended to measure the amino acid Homocysteine (HCY) in serum or EDTA plasma. The homocysteine assay requires four separate reagents, which are added sequentially. A Reducing Reagent releases four separato reagence, willer in a sample or control to free HCY. A Enzyme provem uses the enzyme S-adenosylhomocysteine hydrolase to convert the free HCY to S-adenosylhomocysteine (SAH). SAH from a calibrator, control, or sample to S-adenosyinomes Josent (ethe Solid Phase for binding to a monoclonal anti SAH antibody-acridinium ester conjugate in the Lite Reagent. Following incubation, unbound SAH and anti SAH-acridinium ester conjugate are washed from the Solid Phase. The chemiluminescence of the acridinium ester bound to the Solid Phase is I has . The enemaint of chemiluminescence is inversely proportional to the amount of HCY that was present in the sample.

- 5. Statement of Intended Use
For in vitro diagnostic use in the quantitative determination of total homocysteine (HCY) in serum or EDTA plasma using the ADVIA Centaur® System. This diagnostic test is designed to quantitatively measure HCY in serum or EDTA plasma. Such measurement can aid in the diagnosis and treatment of patients suspected of having homocysteinuria or hyperhomocysteinemia.

6. Summary of Technological Characteristics

The ADVIA Centaur HCY assay is similar to the Abbott IMx Homocysteine assay in several ways. Both require a chemical and enzymatic step to occur before the actual immunoassay starts. The similarities between the Bayer and Abbott reagents are summarized below:

| Step | Bayer Active<br>Compound(s) | Abbott Active<br>Compound(s) |
|--------------------------------------------------------|--------------------------------------|--------------------------------------|
| Chemical reduction of protein bound HCY to<br>free HCY | Dithiothreitol | Dithiothreitol |
| Enzymatic conversion of HCY to SAH | S-adenosyl<br>homocysteine hydrolase | S-adenosyl<br>homocysteine hydrolase |
| Analyte in Calibrator | SAH | SAH |
| Antibody | Mouse monoclonal anti-<br>SAH | Mouse monoclonal anti-<br>SAH |

The systems differ in their detection systems, Abbott assay uses fluorescence polarization while the ADVIA Centaur uses chemiluminescence.

### 7. Method Comparison

We have compared the ADVIA Centaur HCY assay to the Abbott IMx Homocysteine assay in performance. 106 samples were assayed on both systems and yielded the following linear regression statistics:

IMx = 0.98 (ADVIA Centaur) + 0.42 umol/L, R = 0.981

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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 features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. The logo is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 1 82001

Kenneth T. Edds, Ph.D. Manager, Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, NY 10591-5097

Re: k013406

Trade/Device Name: Homocysteine Assay for the ADVIA® Centaur™ Regulation Number: 21 CFR 862.1377 Regulation Name: Urinary homocystine (non-quantitative) test system Regulatory Class: Class II; Class II Product Code: LPS; JIS Dated: October 12, 2001 Received: October 15, 2001

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 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 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.

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This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and ' additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### K013406 510(k) Number:

Device Name: HCY Assay for the ADVIA® Centaur™

Indications for Use:

For in vitro diagnostic use in the quantitative determination of total homocysteine (HCY) in serum or EDTA plasma using the ADVIA Centaur® System. This diagnostic test is designed to quantitatively measure HCY in serum or EDTA plasma. Such measurement can aid in the diagnosis and treatment of patients suspected of having homocysteinuria or hyperhomocysteinemia.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Thomas C. Ponton, Jr. Jean Cooper
Division Director

(Division Sign-Om
Division of Clinical Laboratory Devices
510(k) Number (K013, 40

Prescription Use (Per 21 CFR 801.109)

Over-The-CounterUse OR

(Optional Format 1-2-96)