ACS 180 HOMOCYSTEINE ASSAY

K013606 · Bayer Diagnostics Corp. · LPS · Dec 21, 2001 · Clinical Chemistry

Device Facts

• Record ID: K013606
• Device Name: ACS 180 HOMOCYSTEINE ASSAY
• Applicant: Bayer Diagnostics Corp.
• Product Code: LPS · Clinical Chemistry
• Decision Date: Dec 21, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1377
• Device Class: Class 2

Intended Use

Intended for in vitro diagnostic use in the quantitative determination of total homocysteine (HCY) in serum or EDTA plasma using the ACS:180 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

ACS:180 HCY Assay is a competitive immunoassay for measuring total homocysteine in serum or EDTA plasma. Process: 1) Reducing reagent (dithiothreitol) releases protein-bound/dimerized HCY; 2) Enzyme reagent (S-adenosylhomocysteine hydrolase) converts free HCY to S-adenosylhomocysteine (SAH); 3) SAH competes with solid-phase-bound SAH for binding to monoclonal anti-SAH antibody-acridinium ester conjugate; 4) Unbound components washed away; 5) Chemiluminescence of bound acridinium ester measured. Chemiluminescence is inversely proportional to HCY concentration. Used in clinical laboratory settings on the ACS:180 System. Output provides quantitative HCY levels to assist clinicians in diagnosing and managing homocysteinuria or hyperhomocysteinemia.

Clinical Evidence

Bench testing only. Method comparison study performed on 106 samples comparing ACS:180 HCY assay to the predicate IMx Homocysteine assay. Results yielded linear regression statistics of IMx = 0.98 (ACS:180) + 0.43 µmol/L, with a correlation coefficient (R) of 0.981.

Technological Characteristics

Competitive immunoassay; chemiluminescent detection. Reagents: dithiothreitol (reducing agent), S-adenosylhomocysteine hydrolase (enzyme), mouse monoclonal anti-SAH antibody-acridinium ester conjugate. System: ACS:180. Analyte: Homocysteine in serum or EDTA plasma.

Indications for Use

Indicated for quantitative determination of total homocysteine (HCY) in serum or EDTA plasma to aid in 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 21 2001

# Bayer Diagnostics ACS:180 HCY Assay

K013606

# Section 2 - Summary of Safety and Effectiveness

- 1. Submitter Information

| | Contact Person: | Kenneth T. Edds, Ph.D. |
|----|---------------------------------------------------------|------------------------------------------------------------------------------|
| | Address: | Bayer Diagnostic Corporation<br>511 Benedict Ave.<br>Tarrytown, N.Y. 10591 |
| | | Phone: [phone]<br>FAX: [phone]<br>e-mail: [e-mail] |
| | Date Summary Prepared: | 10/24/01 |
| 2. | Device Information | |
| | Propriety Name: | ACS:180 HCY Assay |
| | Common Name: | HCY assay |
| | Classification Name:<br>Class:<br>CFR:<br>Product Code: | Homocysteine Assay<br>II<br>862.1377<br>75 LPS |

- 3. Predicate Device Information

| Name: | IMx Homocysteine | |
|-------------------|------------------------|--|
| 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 ACS:180 HCY assay is a competitive immunoassay using direct, chemiluminescent 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 protein bound and dimerized HCY in a sample or control to free HCY. A Enzyme Reagent uses the enzyme S-adenosylhomocysteine hydrolase to convert the free HCY to S-adenosylhomocysteine (SAH). SAH from a calibrator, control, or sample competes with SAH bound to the 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 measured. The amount of chemiluminescence is inversely proportional to the amount of HCY that was present in the sample.

- 5. Statement of Intended Use
Intended for in vitro diagnostic use in the quantitative determination of total homocysteine (HCY) in serum or EDTA plasma using the ACS:180 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 ACS:180 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 ACS:180 uses chemiluminescence.

#### 7. Method Comparison

We have compared the ACS:180 HCY assay to the Abbott IMx Homocysteine assay in performance. 106 samples were assayed on both systems and vielded the following linear regression statistics:

IMx = 0.98 (ACS:180) + 0.43 µmol/L, R = 0.981

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 2 1 2001

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

k013606 Re:

Trade/Device Name: Homocysteine Assay for the ACS:180 Regulation Number: 21 CFR 862.1377; 21 CFR 862.1150 Regulation Name: Urinary homocystine (non-quantitative) test system; Calibrator Regulatory Class: Class II; Class II Product Code: LPS; JIS Dated: October 29, 2001 Received: October 31, 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 for are and in to May 28, 1976, the enactment date of the Medical Device Amendments, or to conimer to Prize to 112) 2011 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 Orth 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 1 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/cdrb/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

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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Page 1 of 1

大013606 510(k) Number:

Device Name: HCY Assay for the ACS:180

Indications for Use:

Intended for in vitro diagnostic use in the quantitative determination of total homocysteine (HCY) in serum or EDTA plasma using the ACS:180® System. This nomocyooms (1101) igned to quantitatively measure HCY in serum or EDTA diagnosis tool is acception of can aid in the diagnosis and treatment of patients suspected of having homocysteinuria or hyperhomocysteinemia.

Thomas C. Mort for Ann Cooper
(Division Sign-Off)

Division of Clinical Laboratory 510(k) Number

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-CounterUse

(Optional Format 1-2-96)