(203 days)
Immuno 1 AFP Assay
Immuno 1
No
The summary describes a standard in vitro diagnostic assay for measuring AFP levels in serum. There is no mention of AI, ML, or any computational analysis beyond standard statistical calculations for performance metrics.
No
The device is an in vitro diagnostic device used to measure AFP in human serum as an aid in managing nonseminomatous testicular cancer, which is a diagnostic purpose, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" and "Device Description" sections explicitly state that the device is an "in vitro diagnostic device intended to quantitatively measure afetoprotein (AFP) in human serum... as an aid in the management of nonseminomatous testicular cancer." This directly indicates its role in diagnosis or disease management.
No
The device is an in vitro diagnostic assay, which is a chemical reagent-based test, not a software-only device. It is used on a specific hardware system (Bayer ADVIA IMS system).
Yes, based on the provided information, the Bayer ADVIA® IMS™ AFP assay is an IVD (In Vitro Diagnostic).
Here's why:
- Explicitly Stated in Intended Use and Device Description: Both sections clearly state that the device is an "in vitro diagnostic device".
- Measures a Substance in Human Serum: The device measures afetoprotein (AFP) in human serum, which is a biological sample taken from the body.
- Used to Aid in the Management of a Medical Condition: The intended use specifies that it is an "aid in the management of nonseminomatous testicular cancer". This indicates a medical purpose.
- Requires Interpretation with Other Clinical Data: The intended use mentions that the results "must be interpreted in conjunction with all other available clinical and laboratory data before a medical decision is determined," which is characteristic of IVDs used in clinical decision-making.
Therefore, all the key characteristics of an in vitro diagnostic device are present in the description.
N/A
Intended Use / Indications for Use
The Bayer ADVIA® IMS™ AFP assay is an in vitro diagnostic device intended to quantitatively measure afetoprotein (AFP) in human serum on the Bayer ADVIA IMS system as an aid in the management of nonseminomatous testicular cancer. AFP values obtained using the Bayer ADVIA IMS assay method must be interpreted in conjunction with all other available clinical and laboratory data before a medical decision is determined. AFP testing is not recommended as a screening procedure to detect cancer in the general population.
Product codes
LOJ
Device Description
Not Found
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
Not Found
Summary of Performance Studies
Imprecision:
ADVIA IMS: Level (ng/mL) 4.6, Total CV(%) 2.3; Level (ng/mL) 18.97, Total CV(%) 2.7; Level (ng/mL) 93.52, Total CV(%) 2.6
Immuno 1: Level (ng/mL) 20, Total CV(%) 2.1; Level (ng/mL) 50, Total CV(%) 2.2; Level (ng/mL) 200, Total CV(%) 3.6
Correlation:
Specimen type: Serum, Comparison System (X): Immuno 1, N: 50, Regression Equation: Y=1.06 * X -3.18, Syx (ng/mL): 5.82, R: 0.998, Sample Range (ng/mL): 0.71 - 338.92
Interfering Substances:
Hemoglobin: Interfering Substance Concentration mg/dL 1000, AFP Concentration (ng/mL) 10.2, Effect (% change) 5.6
Lipids (Triglycerides): Interfering Substance Concentration mg/dL 1000, AFP Concentration (ng/mL) 19.8, Effect (% change) 7.5
Bilirubin: Interfering Substance Concentration mg/dL 25, AFP Concentration (ng/mL) 21.3, Effect (% change) -4.5
IgG: Interfering Substance Concentration mg/dL 6.0, AFP Concentration (ng/mL) 16.4, Effect (% change) 8.3
Albumin: Interfering Substance Concentration mg/dL 6.5, AFP Concentration (ng/mL) 14.8, Effect (% change) 4.8
Expected values:
In a group of 250 healthy people, 97.5% of the serum AFP values were found to be 0.8 ng/mL (0.66 IU/mL) to 8.9 ng/mL (7.35 IU/mL).
DISTRIBUTION OF SERUM AFP ASSAY VALUES (Median):
Healthy Subjects: N 350, 0 - 8.9 (%) 98.3, >8.9 - 100 (%) 1.7, >100-400 (%) 0.0, >400 (%) 0.0, MEDIAN 2.5
Testicular Cancer nonseminomatous: N 100, 0 - 8.9 (%) 36.0, >8.9 - 100 (%) 40.0, >100-400 (%) 14.0, >400 (%) 10.0, MEDIAN 20.2
Testicular Cancer mixed germ cell tumor: N 46, 0 - 8.9 (%) 43.5, >8.9 - 100 (%) 45.7, >100-400 (%) 6.5, >400 (%) 4.3, MEDIAN 11.6
Testicular Cancer seminomatous: N 8, 0 - 8.9 (%) 75.0, >8.9 - 100 (%) 25.0, >100-400 (%) 0.0, >400 (%) 0.0, MEDIAN 2.5
Prostate Cancer / Bladder Cancer: N 40, 0 - 8.9 (%) 97.5, >8.9 - 100 (%) 2.5, >100-400 (%) 0.0, >400 (%) 0.0, MEDIAN 3.4
Lung Cancer: N 29, 0 - 8.9 (%) 96.6, >8.9 - 100 (%) 0.0, >100-400 (%) 0.0, >400 (%) 3.4, MEDIAN 3.8
Colorectal Cancer: N 38, 0 - 8.9 (%) 89.5, >8.9 - 100 (%) 10.5, >100-400 (%) 0.0, >400 (%) 0.0, MEDIAN 4.5
Liver Cancer: N 67, 0 - 8.9 (%) 0.0, >8.9 - 100 (%) 31.3, >100-400 (%) 20.9, >400 (%) 47.8, MEDIAN 310.9
Breast Cancer: N 10, 0 - 8.9 (%) 80.0, >8.9 - 100 (%) 20.0, >100-400 (%) 0.0, >400 (%) 0.0, MEDIAN 4.8
Cirrhosis: N 50, 0 - 8.9 (%) 88.0, >8.9 - 100 (%) 12.0, >100-400 (%) 0.0, >400 (%) 0.0, MEDIAN 4.0
Hepatatis: N 50, 0 - 8.9 (%) 88.0, >8.9 - 100 (%) 12.0, >100-400 (%) 0.0, >400 (%) 0.0, MEDIAN 3.9
Benign Genito-urinary disease: N 29, 0 - 8.9 (%) 93.1, >8.9 - 100 (%) 6.9, >100-400 (%) 0.0, >400 (%) 0.0, MEDIAN 3.1
Other nonmalignant: N 37, 0 - 8.9 (%) 100.0, >8.9 - 100 (%) 0.0, >100-400 (%) 0.0, >400 (%) 0.0, MEDIAN 2.3
Analytical Range: 0.08 - 400 ng/mL
Minimum Detectable Concentration: ADVIA IMS 0.08 ng/mL, Immuno 1 0.1 ng/mL
Key Metrics
Not Found
Predicate Device(s)
Immuno 1 AFP Assay
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
OCT 01 2002
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS AFP Assay for Bayer ADVIA® Integrated Modular System (IMS)™
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.
The assigned 510(k) number is:
1. Intended Use
The Bayer ADVIA® IMS™ AFP assay is an in vitro diagnostic device intended to quantitatively measure afetoprotein (AFP) in human serum on the Bayer ADVIA IMS system as an aid in the management of nonseminomatous testicular cancer. AFP values obtained using the Bayer ADVIA IMS assay method must be interpreted in conjunction with all other available clinical and laboratory data before a medical decision is determined. AFP testing is not recommended as a screening procedure to detect cancer in the general population.
2. Predicate Device
| Product Name | Reagent Part # | Calibrator Part # |
|---|---|---|
| Immuno 1 AFP Assay | T01-3100-51 | T03-3187-01 |
3. Device / Method
| Product Name | Reagent Part # / BAN
Number | Calibrator Part # /
BAN Number |
|---------------------|--------------------------------|-----------------------------------|
| ADVIA IMS AFP Assay | B42-3890-23 / | B43-3923-01 / |
| | 09750523 (100 tests) | 09022137 |
| | 01440029 (250 tests) | |
Imprecision
| ADVIA IMS | Immuno 1 | ||
|---|---|---|---|
| Level | |||
| (ng/mL) | Total | ||
| CV(%) | Level | ||
| (ng/mL) | Total | ||
| CV(%) | |||
| 4.6 | 2.3 | 20 | 2.1 |
| 18.97 | 2.7 | 50 | 2.2 |
| 93.52 | 2.6 | 200 | 3.6 |
Correlation (Y= ADVIA IMS, X=comparison system)
| Specimen type | Comparison System (X) | N | Regression Equation | Syx (ng/mL) | R | Sample Range (ng/mL) |
|---|---|---|---|---|---|---|
| Serum | Immuno 1 | 50 | Y=1.06 * X -3.18 | 5.82 | 0.998 | 0.71 - 338.92 |
Interfering Substances
| Interfering
Substance | Interfering Substance
Concentration
mg/dL | AFP
Concentration
(ng/mL) | Effect
(% change) |
|--------------------------|-------------------------------------------------|---------------------------------|----------------------|
| Hemoglobin | 1000 | 10.2 | 5.6 |
| Lipids (Triglycerides) | 1000 | 19.8 | 7.5 |
| Bilirubin | 25 | 21.3 | -4.5 |
| IgG | 6.0 | 16.4 | 8.3 |
| Albumin | 6.5 | 14.8 | 4.8 |
1
Expected values'
As with all tests, each laboratory should establish its own reference range. In a group of 250 healthy people, 97.5% of the serum AFP values were found to be 0.8 ng/mL (0.66 IU/mL) to 8.9 ng/mL (7.35 IU/mL). The distribution of the AFP values for these 250 patient samples is shown in Figure 1. Substantially higher values are often found when malignant disease is present, particularly in patients with nonseminomatous turnors. However, low AFP values do not rule out the presence of malignant disease.
Image /page/1/Figure/2 description: The image is a bar graph showing the frequency of AFP values in ng/mL. The x-axis represents the AFP values, ranging from 1 to >11, while the y-axis represents the frequency, ranging from 0 to 100. The bar for AFP value 3 has the highest frequency, reaching approximately 93, while the bar for AFP value 2 has a frequency of approximately 65.
DISTRIBUTION OF SERUM AFP ASSAY VALUES
| PATIENT
| POPULATION | N | AFP ASSAY VALUES (ng/mL) | MEDIAN | |||
|---|---|---|---|---|---|---|
| 0 - 8.9 | ||||||
| (%) | >8.9 - 100 | |||||
| (%) | >100-400 | |||||
| (%) | >400 | |||||
| (%) | ||||||
| Healthy Subjects | 350 | 98.3 | 1.7 | 0.0 | 0.0 | 2.5 |
| Testicular Cancer | ||||||
| nonseminomatous | 100 | 36.0 | 40.0 | 14.0 | 10.0 | 20.2 |
| Testicular Cancer | ||||||
| mixed germ cell tumor | 46 | 43.5 | 45.7 | 6.5 | 4.3 | 11.6 |
| Testicular Cancer | ||||||
| seminomatous | 8 | 75.0 | 25.0 | 0.0 | 0.0 | 2.5 |
| Prostate Cancer / | ||||||
| Bladder Cancer | 40 | 97.5 | 2.5 | 0.0 | 0.0 | 3.4 |
| Lung Cancer | 29 | 96.6 | 0.0 | 0.0 | 3.4 | 3.8 |
| Colorectal Cancer | 38 | 89.5 | 10.5 | 0.0 | 0.0 | 4.5 |
| Liver Cancer | 67 | 0.0 | 31.3 | 20.9 | 47.8 | 310.9 |
| Breast Cancer | 10 | 80.0 | 20.0 | 0.0 | 0.0 | 4.8 |
| Cirrhosis | 50 | 88.0 | 12.0 | 0.0 | 0.0 | 4.0 |
| Hepatatis | 50 | 88.0 | 12.0 | 0.0 | 0.0 | 3.9 |
| Benign Genito-urinary | ||||||
| disease | 29 | 93.1 | 6.9 | 0.0 | 0.0 | 3.1 |
| Other nonmalignant | 37 | 100.0 | 0.0 | 0.0 | 0.0 | 2.3 |
' Immuno 1 data on file
2
Monitoring data
Two examples of serial patient monitoring studies using Bayer ADVIA IMS assay results in comparison to results obtained for another marketed device are shown in the following figures.
Image /page/2/Figure/2 description: The image contains two line graphs that compare AFP levels over time between ADVIA IMS and a marketed device. The left graph shows a significant increase in AFP levels around 12/10/01, reaching a peak of approximately 160-180 ng/mL by 02/03/02. The right graph shows a smaller increase in AFP levels around 11/05/01, reaching a peak of approximately 60-70 ng/mL. Both graphs show a decline in AFP levels towards the end of the plotted time period.
Analytical Range
0.08 - 400 ng/mL
Minimum Detectable Concentration
| ADVIA IMS
(ng/mL) | Immuno 1
(ng/mL) |
|----------------------|---------------------|
| 0.08 | 0.1 |
4. Conclusion
Performance of the ADVIA IMS AFP Assay on a Bayer ADVIA® IMS™ is equivalent to the performance of the AFP Assay on the predicate device (Immuno 1) and is within proposed specifications. No safety and effectiveness issues have been raised
Kenneth T. Edds Director Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097 Date
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of three human profiles facing right, with flowing lines beneath them. The profiles are meant to represent the department's focus on people and their well-being.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Kenneth T. Edds, Ph.D. Regulatory Affairs Baver Corporation 511 Benedict Avenue Tarrytown, NY 10591-5097
OCT 01 2002
Re: K020807
Trade/Device Name: AFP (α-Fetoprotein) Assay for the ADVIA® IMS™ Regulation Number: 21 CFR 866.6010 Regulation Name: Tumor-associated antigen immunological test system Regulatory Class: Class II Product Code: LOJ Dated: August 29, 2002 Received: September 3, 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. Ilsting 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 (OS) 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 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/cdrl/dsmaldsmamain.html".
Sincerely yours,
Steven Sutman
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
K020807 510(k) Number:
Device Name: AFP (α-Fetoprotein) Assay for the ADVIA® IMS™
Indications for Use:
The Bayer ADVIA® IMS™AFP assay is an in vitro diagnostic device intended to quantitatively measure orfetoprotein (AFP) in human serum on the Bayer ADVIA IMS system as an aid in the management of nonseminomatous testicular cancer. AFP values obtained using the Bayer ADVIA IMS assay method must be interpreted in conjunction with all other available clinical and laboratory data before a medical decision is determined. AFP testing is not recommended as a screening procedure to detect cancer in the general population.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Deborah M. Moore
(Division Sign-O Division of Clinical Labor 510jk) Number _
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-CounterUse
(Optional Format 1-2-96)