ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY

K013272 · Bayer Corp. · KLS · Oct 25, 2001 · Clinical Toxicology

Device Facts

• Record ID: K013272
• Device Name: ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY
• Applicant: Bayer Corp.
• Product Code: KLS · Clinical Toxicology
• Decision Date: Oct 25, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3880
• Device Class: Class 2

Intended Use

For the quantitative determination of theophylline in serum or plasma using the ACS:180 Automated Chemiluminescent Systems. For In Vitro diagnostic use. For in vitro diagnostic use in the quantitative determination of theophylline in serum or plasma using the ADVIA Centaur System.

Device Story

Competitive chemiluminescence immunoassay for quantitative theophylline measurement in human serum/plasma. Patient sample, calibrators, and controls compete with acridinium ester-labeled theophylline for monoclonal mouse anti-theophylline antibody; antibody is coupled to paramagnetic particles via FITC/anti-FITC bridge. After incubation and washing, chemiluminescence is measured in a luminometer. Signal is inversely proportional to theophylline concentration. Used in clinical laboratories on ACS:180 or ADVIA Centaur systems. Results assist clinicians in monitoring therapeutic theophylline levels to optimize asthma treatment and avoid toxicity.

Clinical Evidence

Bench testing only. Correlation studies compared the subject assays (ACS Theophylline 2 and ADVIA Centaur Theophylline 2) against the predicate (ACS Theophylline) using 138 samples. Results showed high correlation (r=0.99) for all comparisons, with slopes ranging from 0.94 to 1.05 and intercepts from -0.9 to 1.36.

Technological Characteristics

Competitive chemiluminescence immunoassay. Solid phase: paramagnetic particles. Antibody coupling: anti-theophylline monoclonal antibody labeled with FITC, bound to anti-FITC antibody on particles. Detection: acridinium ester-labeled theophylline. Energy source: luminometer. Connectivity: automated analyzer systems. Software: embedded system control.

Indications for Use

Indicated for the quantitative determination of theophylline in human serum and plasma as an aid to monitor theophylline levels in patients, such as those with asthma, to manage the risks of over- or under-medication due to variability in absorption and metabolism.

Regulatory Classification

Identification

A theophylline test system is a device intended to measure theophylline (a drug used for stimulation of the muscles in the cardiovascular, respiratory, and central nervous systems) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of theophylline overdose or in monitoring levels of theophylline to ensure appropriate therapy.

Predicate Devices

• ACS Theophylline Assay (K951169)

Submission Summary (Full Text)

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Bayer Diagnostics

K013272

ASC and ADVIA Centaur Theophylline 2 Immunoassays

As required by 21 CFR 807.92, the following 510(k) Summary is provided:

#### 4.1 Submitter Information

Kenneth T. Edds Ph.D. Contact person: Bayer Diagnostics Corporation Address: 511 Benedict Ave. Tarrytown NY 10591

> Phone: [phone] FAX: [phone] e-mail: [e-mail]

#### 4.2 Modified device information

| Proprietary name: | ADVIA Centaur and ACS<br>Theophylline 2 Immunoassays |
|-------------------|------------------------------------------------------|
| Common name: | Theophylline immunoassay |

#### 4.3 Predicate device:

1

| Name: | ACS Theophylline Assay |
|---------------------|-----------------------------------------------------------------------|
| 510(k) Number: | K951169 |
| Original submitter: | Ciba Corning Diagnostics Corp<br>63 North Street<br>Medfield MA 02052 |

Bayer ACS:180/ADVIA Centaur Theophylline 2 - Special 510(k) - Device Modification

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#### 4.4 Device Description

The ACS and ADVIA Centaur Theophylline 2 are competitive chemiluminescence immunoassays are intended for the quantitative determination of theophylline in human serum and plasma. Theophylline in the patient sample, calibrators, standards and controls competes with acridinium ester-labeled theophylline in the Lite Reagent for a limited amount of monoclonal mouse anti-theophylline antibody, which is covalently coupled to paramagnetic particles in the Solid Phase. Following incubation, unreacted acridinium esterlabeled theophylline and unreacted theophylline from the sample are washed from the reaction mixture. The chemiluminescence of the reacted, labeled theophylline is measured in a luminometer. The measured chemiluminescence is inversely proportional to the quantity of theophylline in the sample.

#### 4,5 Statements of Intended Use

#### . ACS Theophylline 2

"For the quantitative determination of theophylline in serum or plasma using the ACS:180 Automated Chemiluminescent Systems. For In Vitro diagnostic use."

#### ADVIA Centaur Theophylline 2 .

"For in vitro diagnostic use in the quantitative determination of theophylline in serum or plasma using the ADVIA Centaur System."

#### Summary of Technological Characteristics 4.6

The ACS and ADVIA Centaur Theophylline 2 Immunoassays are similar to ACS Theophylline assay (the predicate device) in the indications for use, format, performance characteristics, and results. The ACS and ADVIA Centaur Theophylline 2 immunoassays and the ACS Theophylline differ in method used to couple the anti-theophylline monoclonal antibody to the solid phase. In the Theophylline 2 assays, the antibody is labeled with fluorescein isothiocvanate (FITC) and bound to an anti-FITC antibody covalently coupled to the particles. In ACS Theophylline, goat anti-mouse IgG, covalently bound to the particles, binds the anti-theophylline antibody.

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### 4.7 Method Comparison

Substantial equivalence of the ACS and ADVIA Centaur Theophylline 2 assay to the ACS Theophylline is seen.

These correlation studies demonstrates that the ACS:180 & ADVIA Centaur Theophylline 2 assay is equivalent to each other the unmodified predicate devices, the Bayer Corporation ACS Theophylline assay.

| Reference<br>Assay | Test<br>Assay | Slope | Intercept | Correlation<br>Coefficient (r) | N |
|-----------------------|---------------------------------|-------|-----------|--------------------------------|-----|
| ACS<br>Theophylline | ADVIA Centaur<br>Theophylline 2 | 0.94 | 1.36 | 0.99 | 138 |
| ACS<br>Theophylline | ACS<br>Theophylline 2 | 1.00 | -0.24 | 0.99 | 138 |
| ACS<br>Theophylline 2 | ADVIA Centaur<br>Theophylline 2 | 1.05 | -0.9 | 0.99 | 138 |

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

# OCT 2 5 2001

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

k013272 Re:

Trade/Device Name: Bayer Diagnostics ACS: 180 and ADVIA Centaur Theophylline Assay Regulation Number: 21 CFR 862.3880 Regulation Name: Theophylline test system Regulatory Class: Class II Product Code: KLS Dated: September 27, 2001 Received: October 1, 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 nouthoution. The I 211 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, (201) 59 retect 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 mouthanon on your respond and Consumer Assistance at its toll-free number [phone] or 1101) 443-6597 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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510(k) Number (if known): Page

Device Name: Bayer Diagnostics ACS:180 and ADVIA Centaur Theophylline Assay

## Indications for Use:

The ACS:180 and ADVIA Centaur Theophylline 2 Immunoassays are competitive, The AGS.Too and ADVA Oentitative determination of theophyline in human serum
chemiluminescence immunoassay for the quantitative determination of the strum chemilianses cence in minutioussuly for the quartinative addition. Theophyline (1,3and plasma for use on the adtonnated andiyzer manesed by stimulant that is used for the treatment of difflethyliae is a potent brononodiate avel is very important in reducing the risks of over of asthiria. Monitoring a patient a little in viries with of theophylline absorption, metabolism and under-medication resulting wom are innex. The ACS and ADVIA Centaur Theophylline 2 immunoassays are used as an aid to monitor a patient's theophylline level.

The ACS and ADVIA CentaurTheophylline 2 assays are an enhanced version of the current ACS The ACS and ADVIA Octical moophyline = aimed at providing a more versatile assay in the clinical laboratory.

Gean Cooper

(Division S -Off)
Division of linical Laboratory
510(k) Number K013272

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use (Optional Format 1-2-96)