(24 days)
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No
The document describes a standard chemiluminescence immunoassay for measuring theophylline levels. There is no mention of AI, ML, or any computational methods beyond basic data processing for quantitative determination.
No
The device is an immunoassay used to monitor theophylline levels, which aids in preventing over or under-medication, but it does not directly treat a condition.
Yes
The device is used to monitor a patient's theophylline level, which is a key element in managing treatment and preventing adverse effects, indicating its role in diagnosis or disease management.
No
The device description clearly outlines a chemiluminescence immunoassay involving reagents, paramagnetic particles, and a luminometer, indicating a hardware-based laboratory assay, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is for the "quantitative determination of theophylline in human serum and plasma." This is a classic definition of an in vitro diagnostic test, as it analyzes biological samples (serum and plasma) outside of the body to provide information about a patient's health status (theophylline levels).
- Device Description: The description details a "competitive, chemiluminescence immunoassay" that measures theophylline in patient samples. This describes a laboratory test performed on biological specimens.
- Performance Studies: The performance studies involve "Method Comparison" using patient samples to demonstrate equivalence to a predicate device. This is typical for validating an IVD.
- Predicate Device: The mention of a "Predicate Device" (K951169; ACS Theophylline Assay) is a strong indicator that this device is being submitted for regulatory clearance as an IVD, as predicate devices are used for comparison in the regulatory process for IVDs.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ACS:180 and ADVIA Centaur Theophylline 2 Immunoassays are competitive, chemiluminescence immunoassay for the quantitative determination of theophylline in human serum and plasma for use on the automated analyzer. Theophylline (1,3-dimethylxanthine) is a potent bronchodilator and stimulant that is used for the treatment of asthma. Monitoring a patient's theophylline level is very important in reducing the risks of over-medication or under-medication resulting from individual patient variation in theophylline absorption, metabolism and excretion. The ACS and ADVIA Centaur Theophylline 2 immunoassays are used as an aid to monitor a patient's theophylline level.
The ACS and ADVIA Centaur Theophylline 2 assays are an enhanced version of the current ACS Theophylline assay aimed at providing a more versatile assay in the clinical laboratory.
Product codes (comma separated list FDA assigned to the subject device)
KLS
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Assay | Test
Assay | Slope | Intercept | Correlation
Coefficient (r) | N |
|---|---|---|---|---|---|
| ACS
Theophylline | ADVIA Centaur
Theophylline 2 | 0.94 | 1.36 | 0.99 | 138 |
| ACS
Theophylline | ACS
Theophylline 2 | 1.00 | -0.24 | 0.99 | 138 |
| ACS
Theophylline 2 | ADVIA Centaur
Theophylline 2 | 1.05 | -0.9 | 0.99 | 138 |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 862.3880 Theophylline test system.
(a)
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.(b)
Classification. Class II.
0
Bayer Diagnostics
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: 914-524-2446 FAX: 914-524-2500 e-mail: ken.edds.b@bayer.com
4.2 Modified device information
| Proprietary name: | ADVIA Centaur and ACS
Theophylline 2 Immunoassays |
|-------------------|------------------------------------------------------|
| Common name: | Theophylline immunoassay |
4.3 Predicate device:
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| Name: | ACS Theophylline Assay |
|---|---|
| 510(k) Number: | K951169 |
| Original submitter: | Ciba Corning Diagnostics Corp |
| 63 North Street | |
| Medfield MA 02052 |
Bayer ACS:180/ADVIA Centaur Theophylline 2 - Special 510(k) - Device Modification
1
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
Assay | Test
Assay | Slope | Intercept | Correlation
Coefficient (r) | N |
|-----------------------|---------------------------------|-------|-----------|--------------------------------|-----|
| ACS
Theophylline | ADVIA Centaur
Theophylline 2 | 0.94 | 1.36 | 0.99 | 138 |
| ACS
Theophylline | ACS
Theophylline 2 | 1.00 | -0.24 | 0.99 | 138 |
| ACS
Theophylline 2 | ADVIA Centaur
Theophylline 2 | 1.05 | -0.9 | 0.99 | 138 |
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Image /page/3/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services.
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.
4
Page 2 -
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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, (201) 59 retect the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 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
5
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
(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-Counter Use (Optional Format 1-2-96)