(15 days)
P930036, K981592
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No
The device description details a standard immunoassay technology based on antibody binding and chemiluminescence, with no mention of AI or ML algorithms for data processing or interpretation. The performance studies focus on traditional analytical metrics like sensitivity, accuracy, and correlation.
No
This device is an immunoassay designed for the quantitative determination of alpha-fetoprotein (AFP) in human serum, used as an aid in managing testicular cancer, making it a diagnostic tool, not a therapeutic device.
Yes
The device is described as an immunoassay for the quantitative determination of alpha-fetoprotein (AFP) in human serum, used as an aid in managing non-seminomatous testicular cancer. This process of measuring biological markers to help manage a disease definitively classifies it as a diagnostic device.
No
The device description clearly outlines a two-site immunoassay using physical reagents (antibodies, paramagnetic particles) and a chemiluminometric system to measure AFP. This involves hardware components and chemical reactions, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "For the quantitative determination of alpha-fetoprotein (AFP) in the following: human serum". This indicates that the device is used to analyze a sample taken from the human body (serum) to provide information about a specific substance (AFP).
- Device Description: The description details an "immunoassay" which is a common type of in vitro diagnostic test. It also mentions analyzing a "patient sample".
- Performance Studies: The performance studies describe the analysis of "serum samples", further confirming the use of biological samples outside of the body.
These characteristics align directly with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes.
N/A
Intended Use / Indications for Use
For the quantitative determination of alpha-fetoprotein (AFP) in the following:human serum, as an aid in managing non-seminomatous testicular cancer when used in conjunction with physical examination, histology/pathology, and other clinical evaluation procedures, using the Bayer Diagnostics ACS:180 Automated Chemiluminescence System or the ADVIA Centaur System.
Product codes
LOJ
Device Description
The Bayer Diagnostics ACS:180 & ADVIA Centaur AFP immunoassay is a two-site immunoassay using direct chemiluminometric technology, which uses constant amounts of two antibodies. The first antibody, in the Lite Reagent, is a purified polyclonal rabbit anti-AFP antibody labeled with acridinium ester. The second antibody, in the Solid Phase, is a monoclonal mouse anti-AFP antibody covalently coupled to paramagnetic particles. A direct relationship exists between the amount of AFP present in the patient sample and the amount of relative light units (RLU's) detected by the system.
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
The ADVIA Centaur AFP Immunoassay measures AFP concentration up to 1000 ng/mL with a minimum detectable concentration of 1.3 ng/mL. The ACS:180 Immunoassay measures AFP concentration up to 1000 ng/mL with a minimum detectable concentration of 0.19 ng/mL.
Accuracy:
ADVIA Centaur: For 498 serum samples in the range of 1.3 to 943.6 ng/mL, the correlation between the ADVIA Centaur AFP and the ACS:180 AFP is described by the equation: ADVIA Centaur AFP = 1.05 (ACS:180 AFP) - 0.3 ng/mL. Correlation coefficient (r) = 0.99.
ACS:180: For serum samples in the range of 0 to >450 ng/mL. the relationship of the ACS:180 AFP assay to four alternate AFP methods are described by the following equations: (N = 504) ACS:180 = 0.94(Abbott IMX) + 4.6; (N =1575) ACS:180 = 0.92(Kallestd AFP/Ob) + 6.2; (N = 183) ACS:180 = 0.97(Abbott mEIA) - 1.0; (N = 477) ACS:180 = 1.10(Kallestd AFP/Ob) + 1.0.
Key Metrics
Sensitivity: The ADVIA Centaur AFP Immunoassay measures AFP concentration up to 1000 ng/mL with a minimum detectable concentration of 1.3 ng/mL. The ACS:180 Immunoassay measures AFP concentration up to 1000 ng/mL with a minimum detectable concentration of 0.19 ng/mL.
Accuracy:
ADVIA Centaur: Correlation coefficient (r) = 0.99.
Predicate Device(s)
P930036, K981592
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 866.6010 Tumor-associated antigen immunological test system.
(a)
Identification. A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.(b)
Classification. Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.
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MAR 2 7 2002
Summary of Safety and Effectiveness
As required by 21 CFR 807.92, the following 510(k) Summary is provided:
1. Submitter Information
Contact person: Thomas F. Flynn
Baver Diagnostics Address: 63 North Street Medfield, MA 02052
| Phone: | (508) 359-3877 |
|---|---|
| FAX: | (508) 359-3356 |
| e-mail: | thomas.flynn.b@bayer.com |
Date Summary March 8, 2002 Prepared:
2. Device Information
| Proprietary Name: | ACS:180 & ADVIA Centaur AFP |
|---|---|
| Common Name: | AFP Immunoassay |
| Classification Name: | Tumor Associated Antigen Immunological Test System |
3. Predicate Device Information
ACS:180 & ADVIA Centaur AFP Immunoassay Name: Manufacturer: Bayer Diagnostics 510(k) Number: ACS:180 - P930036 (reclassified to class II) ADVIA Centaur - K981592
র্ব Device Description
The Bayer Diagnostics ACS:180 & ADVIA Centaur AFP immunoassay is a two-site immunoassay using direct chemiluminometric technology, which uses constant amounts of two antibodies. The first antibody, in the Lite Reagent, is a purified polyclonal rabbit anti-AFP antibody labeled with acridinium ester. The second antibody, in the Solid Phase, is a monoclonal mouse anti-AFP antibody covalently coupled to paramagnetic particles. A direct relationship exists between the amount of AFP present in the patient sample and the amount of relative light units (RLU's) detected by the system.
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5. Statement of Intended Use
The intended use of ACS:180 & ADVIA Centaur AFP Immunoassay is for the quantitative determination of alpha-fetoprotein (AFP) in the following:
human serum, as an aid in managing non-seminomatous testicular cancer when used in conjunction with physical examination, histology/pathology, and other clinical evaluation procedures, using the Bayer Diagnostics ACS:180 Automated Chemiluminescence System or the ADVIA Centaur System.
Summary of Technological Characteristics 6.
The Bayer Diagnostics ACS:180 & ADVIA Centaur AFP Immunoassay is a two-site sandwich Chemiluminescence immunoassay.
Performance Data 7.
Sensitivity
The ADVIA Centaur AFP Immunoassay measures AFP concentration up to 1000 ng/mL with a minimum detectable concentration of 1.3 ng/mL.
The ACS:180 Immunoassay measures AFP concentration up to 1000 ng/mL with a minimum detectable concentration of 0.19 ng/mL.
Accuracy
ADVIA Centaur:
For 498 serum samples in the range of 1.3 to 943.6 ng/mL, the correlation between the ADVIA Centaur AFP and the ACS:180 AFP is described by the equation:
ADVIA Centaur AFP = 1.05 (ACS:180 AFP) - 0.3 ng/mL
Correlation coefficient (r) = 0.99
ACS:180:
For serum samples in the range of 0 to >450 ng/mL. the relationship of the ACS:180 AFP assay to four alternate AFP methods are described by the following equations:
(N = 504) ACS:180 = 0.94(Abbott IMX) + 4.6 (N =1575) ACS:180 = 0.92(Kallestd AFP/Ob) + 6.2 (N = 183) ACS:180 = 0.97(Abbott mEIA) - 1.0 (N = 477) ACS:180 = 1.10(Kallestd AFP/Ob) + 1.0
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 2 7 2002
Mr. Thomas F. Flynn, RAC Director, Regulatory Affairs Bayer Corporation 63 North Street Medfield, Massachusetts 02052-1688
K020806 Re:
Trade/Device Name: ACS:180 & ADVIA Centaur AFP Immunoassay Regulation Number: 21 CFR § 866.6010 Regulation Name: Carcinoembryonic Antigen CEA Immunological Test System Regulatory Class: II Product Code: LOJ Dated: March 8, 2002 Received: March 12, 2002
Dear Mr. Flynn:
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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact 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 Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Autman
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 of of a
KO20806 -16981592-510(k) Number (if known): _
Device Name: Bayer Diagnostics ACS:180 & ADVIA Centaur AFP Immunoassay
Indications for Use:
For the quantitative determination of alpha-fetoprotein (AFP) in the following:
human serum, as an aid in managing non-seminomatous testicular cancer when used in conjunction with physical examination, histology/pathology, and other dinical evaluation procedures, using the Bayer Diagnostics ACS:180 Automated Chemiluminescence System or the ADVIA Centaur System.
(PLEASE DO NOT WRITE BELOW THIS LINE--CONTINUE ON ANOTHER PAGE, IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
i. Inull H.P.