(455 days)
Not Found
Not Found
No
The device description details a standard immunoassay technology and a cubic-through-zero curve-fitting algorithm, neither of which are indicative of AI/ML. The "Mentions AI, DNN, or ML" section is also marked as "Not Found".
No.
This device is an in vitro diagnostic device used to quantify HER-2/neu in human serum for monitoring metastatic breast cancer, not to provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The Bayer Immuno 1™ Her-2/neu Assay is an in vitro, diagnostic device".
No
The device description clearly outlines a laboratory-based immunoassay utilizing physical reagents (monoclonal antibodies, magnetic particles, colorimetric substrate) and a system for incubation, washing, and absorbance measurement. While software is likely used for data analysis and curve fitting, the core of the device is a hardware-dependent in vitro diagnostic assay.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The document explicitly states the device is "an in vitro, diagnostic device intended for use in the quantitative determination of HER-2/neu in human serum." This directly aligns with the definition of an in vitro diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or treatment.
- Sample Type: The assay is performed on "human serum," which is a specimen taken from the human body.
- Purpose: The results are intended to be used "in the follow-up and monitoring of patients with metastatic breast cancer" and "in conjunction with information available from clinical and other diagnostic procedures in the management of breast cancer." This indicates a diagnostic and monitoring purpose.
- Device Description: The description details an immunoassay technology that analyzes a biological sample (serum) to measure a specific analyte (HER-2/neu). This is characteristic of IVD devices.
N/A
Intended Use / Indications for Use
The Bayer Immuno 1™ HER-2/neu Assay is an in vitro diagnostic assay intended to quantitatively measure HER-2/neu protein in human serum on the Bayer Immuno 1 M System. HER-2/neu values obtained may be used in the follow-up and monitoring of patients with metastatic breast cancer. 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 serum measurement of HER-2/neu as a prognostic indicator for early detection of recurrence and in the management of patients on immunotherapy regimens has not been fully established.
Product codes
NCW
Device Description
The Bayer Immuno I™ HER-2/neu Assay utilizes a well-established immunoassay technology in which one monoclonal HER-2/neu antibody (NB-3) is conjugated to fluorescein (designated Reagent 1, or R1) and the Fab' fragment of another monoclonal HER-2/neu antibody (TA-1) is conjugated to alkaline phosphatase (Reagent 2, or R2). The R1 and R2 conjugates are reacted with patient sample, calibrator, or control and are incubated at 37℃ on the system. Immuno 1 Magnetic Particles coated with an antifluorescein antibody (mIMP™ Reagent) are then added and a second incubation occurs during which the antibody complex is bound. The magnetic particles complexed with the immunological sandwich are then washed to separate unbound molecules, and a colorimetric substrate is added. The rate of conversion of substrate to a compound with absorbance at 405 and 450 nm is measured is proportional to the concentration of HER-2/neu in the sample. A cubic-through-zero curve-fitting algorithm is used to generate standard curves.
The assay has a range of zero to 250 ng/mL. The Bayer SETpoint™ HER-2/neu Calibrators consist of a set of six calibrator levels at 0, 10, 25, 60, 125, and 250 ng/mL. The Bayer TESTpoint™ HER-2/neu Controls consist of a set of three control levels at approximately 15, 50 and 100 ng/mL.
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
Not Found
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
The clinical utility of the Bayer Immuno I HER-2/neu assay in monitoring patients with metastatic breast cancer was evaluated using retrospective serum samples from three clinical sites in the United States. Serum HER-2/neu values were measured in 60 patients with metastatic breast cancer over a 6-12 month period. These results were then separated into groups that either showed HER-2/neu values that paralleled the clinical course of disease, or HER-2/neu values that did not parallel the clinical course as follows: For all patients whose pretreatment serum HER-2/neu values exceeded 15 ng/mL, all serial measurements were analyzed visit-to-visit and serial changes in serum HER-2/neu were correlated with changes in clinical status. For each pair of serial measurements, an increase of equal or greater than 15% was considered to indicate progression, and a change of less than 15% increase was considered to indicate a lack of progression. Results presented in Table 1 show the overall correspondence of the serial HER-2/neu changes and changes in clinical status.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical studies were performed to validate the performance of the method according to the protocol entitled "Non-clinical Testing Protocol for the Evaluation of the of the Bayer Immuno 1™ HER-2/neu Assay." Protocols were performed at the Bayer Corporation laboratories in Tarrytown, NY and Elkhart, IN. These studies included evaluation of interfering substances, cross-reactivity, heterophilic antibodies, calibration linearity, sample linearity, parallelism (sample dilution), hook effect, reproducibility, and reagent lot-to-lot variation.
The clinical evaluation of Immuno 1 HER-2/neu Assay as an aid in the management of breast cancer patients with Stage IV metastatic disease, during the course of disease and therapy, was conducted at three US clinical trial sites.
The clinical utility of the Bayer Immuno I HER-2/neu assay in monitoring patients with metastatic breast cancer was evaluated using retrospective serum samples from three clinical sites in the United States. Serum HER-2/neu values were measured in 60 patients with metastatic breast cancer over a 6-12 month period. These results were then separated into groups that either showed HER-2/neu values that paralleled the clinical course of disease, or HER-2/neu values that did not parallel the clinical course as follows: For all patients whose pretreatment serum HER-2/neu values exceeded 15 ng/mL, all serial measurements were analyzed visit-to-visit and serial changes in serum HER-2/neu were correlated with changes in clinical status. For each pair of serial measurements, an increase of equal or greater than 15% was considered to indicate progression, and a change of less than 15% increase was considered to indicate a lack of progression. Results presented in Table 1 show the overall correspondence of the serial HER-2/neu changes and changes in clinical status.
Key results: Results clearly demonstrated the lack of a hook effect in the Immuno 1 HER-2/neu Assay at Her-2/neu values = 15% increased HER-2/neu: 66 Progression, 33 Lack of Progression
§ 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
SEP 2 9 2000
510(K) SUMMARY
FOR THE
BAYER IMMUNO 1™ HER-2/neu ASSAY
This summary of 510(k) safety and effectiveness information is being submitted in Fills summary of a requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K992228
GENERAL INFORMATION 1.
Trade Name:
Bayer Immuno 1™ HER-2/neu Assay
Classification Name:
Tumor-Associated Antigen Immunological Test Systems
Fredric Cline
Fredrick Clerie Director Regulatory Affairs Bayer Corporation Business Group Diagnostics 511 Benedict Avenue Tarrytown, NY 10591 Phone 914-524-2954 FAX 914-524-2500
9-22-2000
Date
1
This premarket notification is to add the Bayer Immuno 1™HER-2/neu Assay to the intended use of the Bayer Immuno 1™System. In this 510(k) application, the performance and clinical safety and effectiveness of the Bayer Immuno 1 HER-2/neu Assay for the management (monitoring) of metastatic breast cancer patients has been established by external clinical studies in the target population of longitudinal metastatic breast cancer patients and by comparison to accepted diagnostic procedures in accordance with the "Guidance Document For Submission of Tumor Associated Antigen Premarket Notifications, 510(k), to the FDA." Clinical evaluations of the Bayer Immuno 1 HER-2/neu Assay at three US clinical trial sites demonstrated clinical safety and effectiveness. These studies validated clinical performance characteristics and the comparison to accepted diagnostic procedures.
INDICATIONS FOR USE 2.
The Bayer Immuno 1™ HER-2/neu Assay is an in vitro diagnostic assay intended to quantitatively measure HER-2/neu protein in human serum on the Bayer Immuno 1 M System. HER-2/neu values obtained may be used in the follow-up and monitoring of patients with metastatic breast cancer. 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 serum measurement of HER-2/neu as a prognostic indicator for early detection of recurrence and in the management of patients on immunotherapy regimens has not been fully established.
DEVICE DESCRIPTION 3.
The Bayer Immuno I™ HER-2/neu Assay utilizes a well-established immunoassay technology in which one monoclonal HER-2/neu antibody (NB-3) is conjugated to fluorescein (designated Reagent 1, or R1) and the Fab' fragment of another monoclonal HER-2/neu antibody (TA-1) is conjugated to alkaline phosphatase (Reagent 2, or R2). The R1 and R2 conjugates are reacted with patient sample, calibrator, or control and are incubated at 37℃ on the system. Immuno 1 Magnetic Particles coated with an antifluorescein antibody (mIMP™ Reagent) are then added and a second incubation occurs during which the antibody complex is bound. The magnetic particles complexed with the
2
immunological sandwich are then washed to separate unbound molecules, and a colorimetric substrate is added. The rate of conversion of substrate to a compound with absorbance at 405 and 450 nm is measured is proportional to the concentration of HER-2/neu in the sample. A cubic-through-zero curve-fitting algorithm is used to generate standard curves.
The assay has a range of zero to 250 ng/mL. The Bayer SETpoint™ HER-2/neu Calibrators consist of a set of six calibrator levels at 0, 10, 25, 60, 125, and 250 ng/mL. The Bayer TESTpoint™ HER-2/neu Controls consist of a set of three control levels at approximately 15, 50 and 100 ng/mL.
SUMMARY OF STUDIES 4.
Non-clinical studies were performed to validate the performance of the method according to the protocol entitled "Non-clinical Testing Protocol for the Evaluation of the of the Bayer Immuno 1™ HER-2/neu Assay." Protocols were performed at the Bayer Corporation laboratories in Tarrytown, NY and Elkhart, IN. These studies included evaluation of interfering substances, cross-reactivity, heterophilic antibodies, calibration linearity, sample linearity, parallelism (sample dilution), hook effect, reproducibility, and reagent lot-to-lot variation.
The clinical evaluation of Immuno 1 HER-2/neu Assay as an aid in the management of breast cancer patients with Stage IV metastatic disease, during the course of disease and therapy, was conducted at three US clinical trial sites.
Characterization of the Antigen. 4.1
The calibrator antigen used in the Bayer Immuno 1 HER-2/neu assay is derived from a recombinant 3T3 mouse cell line 3-30. HER-2/neu p105 antigen is harvested from the tissue culture media and concentrated 10-fold. Western blot analysis shows a single dominant band with a molecular weight of 105,000 Daltons consistent with the HER-2/neu extracellular domain.
3
Characterization of the Antibodies 4.2
The NB-3 monoclonal (part no. 7591MR) and TA-1 monoclonal anti-HER-2/neu (part no. 7590MR) are used in the preparation of the R1 and R2 reagents for the Bayer Immuno 1m HER-2/neu Assay. The procedures for the preparation of the NB-3 R1 Reagent fluorescein and TA-1 R2 Reagent alkaline phosphatase conjugates are standard protocols similar to those used for conjugate preparation for other 510(k) Bayer Immuno 1 assays. Bayer Corporation (Business Group Diagnostics) in Elkhart is the approved supplier for the antibodies and antibody conjugates.
Assay Performance 4.3
Specificity: Interference 4.3.1
The recovery of HER-2/neu from patient samples was studied before and after spiking the serum samples with the potentially interfering substance. Each potential interferent was tested at a maximum concentration.
The Immuno 1 HER-2/neu Assay was performed on serum samples or pools of serum to which were added various concentrations of triglycerides, hemoglobin, immunoglobulin, bilirubin, albumin or cholesterol. HER-2/neu values were also measured in serum samples after spiking with either an individual chemotherapeutic drug, "Over the Counter" (OTC) drug, vitamin or HERCEPTIN® (Trastuzumab), trademark of Genetech BioOncology, South San Francisco, CA. None of the potential endogenous or exogenous interferents demonstrated any significant interfering effects on HER-2/neu recovery.
Cross-Reactivity 4.3.2
Possible cross-reactions in the Immuno 1 HER-2/neu assay were studied by comparing HER-2/neu recoveries in patient samples with Human Epidermal Growth Factor. The maximum effect seen with this crossreactant was not significant ( Trade Name: Bayer Immuno 1™ HER-2/neu Assay Regulatory Class: II Product Code: NCW Dated: July 6, 2000 Received: July 10, 2000
Dear Mr. Clerie:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
10
Page 2
This letter will allow you to begin marketing your device as described in your 510(k) premarket This letter will anow you to oogin manating your device to a legally marketed nouncation. The I D7X Intamg of bassification 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 IT you desire specific actrice for your assic devices), please contact the Office of Compliance at additionally 807.10 for mi vitio diagnestions on the promotion and advertising of your device, (301) 594-4560. Practiceliance 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 Information on your rosponsionness and 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 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
11
001001
Page 1 of 1
510(k) Number (if known):
Device Name: Bayer Immuno 1TM HER-2/neu Assay
Indications For Use:
The Bayer Immuno 1™ Her-2/neu Assay is an in vitro, diagnostic device intended for use in the quantitative determination of HER-2/neu in human serum. HER-2/neu values obtained may be used in the follow-up and monitoring of patients with metastatic breast cancer. 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 serum measurement of HER-2/neu as a prognostic indicator for early atine) of and in the management of patients on immunotherapy regimens has not been fully established.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K992228
Prescription Use ✓
OR
Over-the-counter Use
Prescription Use (Per 21 CFR 801.109)
(Optional Format 1-2-96)