(57 days)
Not Found
No
The device description details a standard immunoassay technology and does not mention any AI or ML components. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
No
The device is an in vitro diagnostic (IVD) test used for quantitative determination of a protein in serum to monitor cancer patients, not for direct treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use in the quantitative determination of the HER-2/neu protein in human serum or using the ADVIA Centaur System." and mentions its use in "follow-up and monitoring of patients with metastatic breast cancer". These phrases clearly indicate a diagnostic purpose.
No
The device description clearly outlines a physical immunoassay kit with reagents and paramagnetic particles, indicating it is a hardware-based in vitro diagnostic device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The very first sentence explicitly states "For in vitro diagnostic use". It also describes the device's purpose as the "quantitative determination of the HER-2/neu protein in human serum". This clearly indicates it's used to test samples taken from the human body outside of the body to diagnose or monitor a condition.
- Device Description: The description details a "two-site sandwich immunoassay using direct, chemiluminescent technology" and the components used (antibodies, paramagnetic particles). This is a typical description of a laboratory test performed on biological samples.
- Intended User/Care Setting: It states the test should be used "by or under the order of a physician," which aligns with the use of diagnostic tests in a clinical setting.
- Summary of Performance Studies: The performance study compares the device to a "FDA-cleared Bayer Immuno-1 HER-2/neu assay," which is also an IVD. The study focuses on the relationship and equivalence of the assays, a common practice for demonstrating the performance of a new IVD.
- Predicate Device(s): The listing of a predicate device (K992228 Bayer Immuno-1 HER-2/neu) further confirms its classification as an IVD, as predicate devices are used for comparison in the regulatory clearance process for new IVDs.
All of these points strongly support the conclusion that this device is an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
For in vitro diagnostic use in the quantitative determination of the HER-2/neu protein in human serum or using the ADVIA Centaur System. HER-2/neu values obtained may be used in the follow-up and monitoring of patients with metastatic breast cancer whose initial serum HER-2/neu level is greater than 15 ng/mL. HER-2/neu values should be used in conjunction with information available from clinical and other diagnostic procedures in the management of breast cancer. The clinical utility of the measurement of HER-2/neu in serum as a prognostic indicator for early recurrence and in the management of patients on immunotherapy has not been fully established. This test should be used by or under the order of a physician. This assay is not intended for use on any other system.
Product codes
NCW
Device Description
The ADVIA Centaur HER-2/neu assay is a fully automated, two-site sandwich immunoassay using direct, chemiluminescent technology. The Lite Reagent is composed of the monoclonal mouse antibody, TA-1 labeled with acridinium ester. The Fluorescein Conjugate Reagent is composed of the monoclonal mouse antibody, NB-3, labeled with fluorescein. The two monoclonal antibodies are specific for unique epitopes on the extracellular domain of HER-2/neu. The Solid Phase is composed of purified monoclonal mouse capture antibody, which is covalently coupled to paramagnetic particles. The sample is incubated with Fluorescein Conjugate Reagent and Lite Reagent simultaneously for 5.5 minutes. After this incubation, the Solid Phase is added and the mixture is incubated for an additional 2.75 minutes. After this final incubation, the immuno-complex formed is washed. The measured chemiluminescence is directly proportional to the quantity of HER-2/neu antigen in the sample.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
used by or under the order of a physician.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
For 196 samples in the assay range of 0.2-250 ng/mL, the relationship of the ADVIA Centaur HER-2/neu assay to the Bayer Immuno 1™ HER-2/neu assay is described by the following equation (calculated Linear Least Sum Squares Regression):
ADVIA Centaur HER-2/neu = 0.97 (Immuno 1) + 0.56 ng/mL
The correlation coefficient r is 0.99
The data demonstrate substantial equivalence of the ADVIA Centaur HER-2/neu assay to the FDA-cleared Bayer Immuno-1 HER-2/neu assay as an adjunctive test for use in the management (monitoring) of metastatic breast cancer patients during the course of disease and therapy.
Key Metrics
Correlation coefficient r is 0.99
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
KO24017
Page 1 of 2
Premarket Notification - 510(k)
JAN 3 0 2003
ADVIA Centaur HER-2/neu Immunoassay
510(k) Summary of Safety and Effectiveness
This summary of safety and effectiveness is being submitted in accordance with the requirements of The Safe Medical Devices Act of 1990 (SMDA 1990) and 21 CFR 807.92.
The assigned 510(k) number is:
7.1 General Information
| Date of Summary Update: | November 22, 2002 |
|---|---|
| Applicant: | Kenneth T. Edds, Ph.D. |
| Manager, Regulatory Affairs | |
| Business Group Diagnostics | |
| 511 Benedict Ave. | |
| Tarrytown, NY 10591 | |
| Phone: 914-524-2446 | |
| Fax: 914-524-2500 | |
| Ken.edds.b@bayer.com | |
| Owner: | Bayer Corporation |
| Business Group Diagnostics | |
| 511 Benedict Ave. | |
| Tarrytown, NY 10591 | |
| Establishment Registration No: 2432235 | |
| Manufacturer: | Bayer Corporation |
| 333 Coney Street | |
| Walpole, MA 02032 | |
| Establishment Registration No: 1219913 | |
| Device Name: | ADVIA Centaur® HER-2/neu assay |
| Common or Usual Name: | Chemiluminescence immunoassay kit for the |
| determination of HER-2/neu antigen | |
| using Bayer Corporation's | |
| ADVIA Centaur automated analyzer. | |
| Classification: | |
| Name: | |
| Class: | |
| CFR: | |
| Product Code: | Tumor associated antigen immunological system |
| II | |
| 866.6010 | |
| 82 NCW |
This submission was prepared in accordance with "Guidance Document for Submission of Tumor Associated Antigen Premarket Notifications".
Substantial Equivalence To: Bayer Immuno-1 HER-2/neu
K992228 510(k) Number:
1
7.2 Intended Use
For in vitro diagnostic use in the quantitative determination of the HER-2/neu protein in human serum or using the ADVIA Centaur System. HER-2/neu values obtained may be used in the follow-up and monitoring of patients with metastatic breast cancer whose initial serum HER-2/neu level is greater than 15 ng/mL. HER-2/neu values should be used in conjunction with information available from clinical and other diagnostic procedures in the management of breast cancer. The clinical utility of the measurement of HER-2/neu in serum as a prognostic indicator for early recurrence and in the management of patients on immunotherapy has not been fully established. This test should be used by or under the order of a physician. This assay is not intended for use on any other system.
7.3 Device Description
The ADVIA Centaur HER-2/neu assay is a fully automated, two-site sandwich immunoassay using direct, chemiluminescent technology. The Lite Reagent is composed of the monoclonal mouse antibody, TA-1 labeled with acridinium ester. The Fluorescein Conjugate Reagent is composed of the monoclonal mouse antibody, NB-3, labeled with fluorescein. The two monoclonal antibodies are specific for unique epitopes on the extracellular domain of HER-2/neu. The Solid Phase is composed of purified monoclonal mouse capture antibody, which is covalently coupled to paramagnetic particles. The sample is incubated with Fluorescein Conjugate Reagent and Lite Reagent simultaneously for 5.5 minutes. After this incubation, the Solid Phase is added and the mixture is incubated for an additional 2.75 minutes. After this final incubation, the immuno-complex formed is washed. The measured chemiluminescence is directly proportional to the quantity of HER-2/neu antigen in the sample.
7.4 Comparison to the Predicate Device
The ADVIA Centaur HER-2/neu immunoassay kit is similar to the Baver Immuno-1 HER-2/neu kit in the indications for use, format, performance characteristics, and results. The ADVIA Centaur tests differ mainly in their signal system as compared to the Immuno-1 principle. In the ADVIA Centaur method, a chemiluminogenic molecule (acridinium ester) is used to replace the Alkaline Phosphatase signal used in the Immuno-1 assay.
7.5 Equivalence to Predicate Device
For 196 samples in the assay range of 0.2-250 ng/mL, the relationship of the ADVIA Centaur HER-2/neu assay to the Bayer Immuno 1™ HER-2/neu assay is described by the following equation (calculated Linear Least Sum Squares Regression):
ADVIA Centaur HER-2/neu = 0.97 (Immuno 1) + 0.56 ng/mL
The correlation coefficient r is 0.99
The data demonstrate substantial equivalence of the ADVIA Centaur HER-2/neu assay to the FDA-cleared Bayer Immuno-1 HER-2/neu assay as an adjunctive test for use in the management (monitoring) of metastatic breast cancer patients during the course of disease and therapy.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle or bird-like figure, represented by a series of curved lines. The design is simple and monochromatic, with the text and image in black against a white background.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 3 0 2003
Kenneth T. Edds, Ph.D. Manager Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, NY 10591-5097
Re: K024017
Trade/Device Name: Bayer ADVIA Centaur HER-2/ neu assay Regulation Number: 21 CFR 866.6010 Regulation Name: Tumor-associated antigen immunological test system Regulatory Class: Class II Product Code: NCW Dated: November 26, 2002 Received: December 4, 2002
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
3
Page 2 - -
This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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 Putman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1
510(k) Number:
Bayer ADVIA Centaur HER-2/ neu assay Device Name:
Indications for Use:
For in vitro diagnostic use in the quantitative determination of the HER-2/neu protein in human serum using the ADVIA Centaur System. HER-2/neu values obtained may be used in the follow-up and monitoring of patients with metastatic breast cancer whose initial serum HER-2/neu level is greater than 15 ng/mL. HER-2/neu values should be used in conjunction with information available from clinical and other diagnostic procedures in the management of breast cancer. The clinical utility of the measurement of HER-2/neu in serum as a prognostic indicator for early recurrence and in the management of patients on immunotherapy has not been fully established. This test should be used by or under the order of a physician. This assay is not intended for use on any other system.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
J. Reeves for J. Bautista
sion of Clinical I
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-CounterUse
(Optional Format 1-2-96)