(132 days)
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Not Found
No
The summary describes a standard immunoassay for measuring a specific biomarker and does not mention any AI or ML components. The performance studies focus on analytical characteristics like imprecision, linearity, and correlation, typical of laboratory assays, not AI/ML model evaluation.
No.
This device is an in vitro diagnostic immunoassay intended to measure a biomarker (CA 125) for monitoring ovarian cancer, not to provide therapy or treatment.
Yes
The text explicitly states: "The Bayer ADVIA® IMS™CA 125 II Assay is an in vitro diagnostic device" and "CA 125 II Assay is indicated as an aid in the management (monitoring) of ovarian cancer patients when used in conjunction with other diagnostics procedures." It also mentions its use as "an aid in the detection of residual ovarian carcinoma."
No
The device is an in vitro immunoassay, which is a laboratory test that uses biological components (like antibodies) to measure substances in a sample. This inherently involves physical reagents and laboratory equipment (the Bayer ADVIA® IMS™), making it a hardware-dependent device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
The Intended Use/Indications for Use section explicitly states: "This in vitro immunoassay is intended to quantitatively measure OC 125 reactive determinants..." and "The Bayer ADVIA® IMS™CA 125 II Assay is an in vitro diagnostic device intended to quantitatively measure OC 125 reactive determinants...".
The Device Description also begins with "This in vitro immunoassay is intended to quantitatively measure OC 125 reactive determinants...".
These statements clearly identify the device as an in vitro diagnostic.
N/A
Intended Use / Indications for Use
This in vitro immunoassay is intended to quantitatively measure OC 125 reactive determinants associated with a high molecular weight glycoprotein in serum of women with primary epithelial invasive ovarian cancer using ADVIA IMS CA125 II Assay on a Bayer ADVIA® IMS™. CA 125 II Assay is indicated as an aid in the management (monitoring) of ovarian cancer patients when used in conjunction with other diagnostics procedures. The CA125 II Assay is also indicated as a one-time test for use as an aid in the detection of residual ovarian carcinoma in patients who have undergone firstline therapy and would be considered diagnostic second-look procedures. This assay is not intended for screening or diagnosis of ovarian cancer or for use on any other system.
The Bayer ADVIA® IMS™CA 125 II Assay is an in vitro diagnostic device intended to quantitatively measure OC 125 reactive determinants associated with a high molecular weight glycoprotein in serum of women with primary epithelial invasive ovarian cancer. The CA 125 II Assay is indicated as an aid in the management (monitoring) of ovarian cancer patients when used in conjunction with other diagnostic procedures. The CA 125 II Assay is also indicated as a one-time test for use as an aid in the detection of residual ovarian carcinoma in patients who have undergone first-line therapy and would be considered for diagnostic second-look procedures. An assay value of greater than 35 UlmL is predictive of residual disease, provided that alrernate causes of elevated CA 125 II Assay values can be excluded. It is recommended that the assessment and treatment of patients with ovarian cancer and the use of this CA 125 II Assay be under the order of a physician trained and experienced in the management of gynecologic cancers. This assay is not intended for screening or diagnosis of ovarian cancer or for use on any other system.
Product codes
LTK
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
Not Found
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
physician trained and experienced in the management of gynecologic cancers.
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)
Imprecision:
ADVIA IMS:
Level (U/mL) Total CV(%) 26.8 3.0, 74.1 1.9, 169.8 2.5
Immuno 1:
Level (U/mL) Total CV(%) 30.2 2.4, 80.6 2.5, 200.2 2.6
Linearity:
Linearity was evaluated by diluting a high CA 125 II serum sample with a serum pool containing low CA 125 II level. Recovery was acceptable ranging from 96.7%, meeting specifications and in concordance with the Immuno 1 (predicate).
Parallelism:
Parallelism was evaluated by diluting a serum sample with a high CA125 II level, with Immuno 1 Sample Diluent B. Recovery was acceptable ranging from 95.6% to 109.7% in concordance with the Immuno 1 (predicate)
Correlation (Y = ADVIA IMS, X=comparison system):
Specimen type: Serum
Comparison System (X): Immuno 1
N: 45
Regression Equation: Y = 1.047 * X - 3.94
Syx (U/mL): 13.74
R: 0.994
Sample Range (U/mL): 5.1-509.2
Longitudinal Samples Evaluation:
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 accompanying figures. Correspondence of ADVIA IMS CA125II Assay levels with the clinical course of disease was evaluated using guidelines by Bast et al, whereby a doubling of CA125 II values reflect disease progression and a 50% decrease in CA125 II values reflects response to therapy.
Interfering Substances:
Separate low serum pools were spiked with the following materials: triglycerides (1000 mg/dL), hemoglobin (1000 mg/dL), bilirubin (25 mg/dL), albumin (6.5 g/dL), immunoglobulin (6.0 g/dL), over the counter medications, vitamins, caffeine and drug pools (two times lethal dose). In all cases the observed recovery bias was found to be of no clinical significance.
Analytical Range: 0.5 – 550 U/mL
Minimum Detectable Concentration:
ADVIA IMS (U/mL): 0.5
Immuno 1 (U/mL): 0.9
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Clinical Status: Change
Change: 18
NoChange: 7
Total: 25
Clinical Status: NoChange
Change: 1
NoChange: 2
Total: 3
Total
Change: 19
NoChange: 9
Total: 28
Estimate Sensitivity: 94.7% (95% CI: 74.0% to 99.9%)
Specificity: 22.2% (95% CI: 2.8% to 60.0%)
Positive predictive value: 72.0%
Negative predictive value: 66.7%
Concordance: 71.4%
Predicate Device(s)
Immuno 1 CA125 II 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.
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NOV 2 7 2002
Image /page/0/Picture/1 description: The image shows the Bayer logo. The word "Bayer" is written in a bold, sans-serif font on the left side of the image. To the right of the word is a circular symbol with the word "BAYER" written vertically inside. The letters are arranged in a cross shape.
CA 125 II ASSAY CA 125 II (06/18/02)
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS CA125 II 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: K00033399
1. Intended Use
This in vitro immunoassay is intended to quantitatively measure OC 125 reactive determinants associated with a high molecular weight glycoprotein in serum of women with primary epithelial invasive ovarian cancer using ADVIA IMS CA125 II Assay on a Bayer ADVIA® IMS™. CA 125 II Assay is indicated as an aid in the management (monitoring) of ovarian cancer patients when used in conjunction with other diagnostics procedures. The CA125 II Assay is also indicated as a one-time test for use as an aid in the detection of residual ovarian carcinoma in patients who have undergone firstline therapy and would be considered diagnostic second-look procedures. This assay is not intended for screening or diagnosis of ovarian cancer or for use on any other system.
2. Predicate Device
| Product Name | Reagent Part # | Calibrator Part # |
|---|---|---|
| Immuno 1 CA125 II Assay | T01-3560-51 | T03-3562-01 |
3. Device / Method
| Product Name | Reagent Part # /
BAN Number | Calibrator Part # /
BAN Number |
|---------------------------|--------------------------------|-----------------------------------|
| ADVIA IMS CA 125 II Assay | B42-3893-21 /
03692807 | B43-3925-01 /
06578142 |
4. Performance
| Imprecision | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ADVIA IMS | Immuno 1 | ||||||||||||||||
| Level | |||||||||||||||||
| (U/mL) Total | |||||||||||||||||
| CV(%) 26.8 3.0 74.1 1.9 169.8 2.5 | Level | ||||||||||||||||
| (U/mL) Total | |||||||||||||||||
| CV(%) 30.2 2.4 80.6 2.5 200.2 2.6 |
Linearity
Linearity was evaluated by diluting a high CA 125 II serum sample with a serum pool containing low CA 125 II level. Recovery was acceptable ranging from 96.7%, meeting specifications and in concordance with the Immuno 1 (predicate).
Parallelism
Parallelism was evaluated by diluting a serum sample with a high CA125 II level, with Immuno 1 Sample Diluent B. Recovery was acceptable ranging from 95.6% to 109.7% in concordance with the Immuno 1 (predicate)
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CA 125 II ASSAY CA 125 II (06/18/02)
| Correlation (Y = ADVIA IMS, X=comparison system) | ||||||
|---|---|---|---|---|---|---|
| Specimen type | Comparison System (X) | N | Regression Equation | Syx (U/mL) | R | Sample Range (U/mL) |
| Serum | Immuno 1 | 45 | $1.047 * X - 3.94$ | 13.74 | 0.994 | 5.1-509.2 |
Longitudinal Samples Evaluation
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/1/Figure/7 description: The image contains two line graphs titled "Longitudinal Sample 1" and "Longitudinal Sample 2". Both graphs depict the levels of CA125 [U/mL] over time, with the x-axis representing the date and the y-axis representing the CA125 levels. Each graph contains two lines, labeled "ADVIA IMS" and "Immuno 1", showing the CA125 levels measured by each method. In the first graph, the CA125 levels for both methods increase from approximately 20 to around 90 between April 1998 and November 1998, while in the second graph, the CA125 levels decrease from around 500 to approximately 80 between April 1996 and December 1996, then increase to around 200 by July 1997.
Correspondence of ADVIA IMS CA125II Assay levels with the clinical course of disease was evaluated using guidelines by Bast et al, whereby a doubling of CA125 II values reflect disease progression and a 50% decrease in CA125 II values reflects response to therapy.
| Clinical Status | Change | NoChange | Total |
|---|---|---|---|
| Change | 18 | 7 | 25 |
| NoChange | 1 | 2 | 3 |
| Total | 19 | 9 | 28 |
| Estimate | 95% CI | ||
| Sensitivity | 94.7% | 74.0% | to 99.9% |
| Specificity | 22.2% | 2.8% | to 60.0% |
| Positive predictive value | 72.0% | ||
| Negative predictive value | 66.7% | ||
| Concordance | 71.4% |
Interfering Substances
Separate low serum pools were spiked with the following materials: triglycerides (1000 mg/dL), hemoglobin (1000 mg/dL), bilirubin (25 mg/dL), albumin (6.5 g/dL), immunoglobulin (6.0 g/dL), over the counter medications, vitamins, caffeine and drug pools (two times lethal dose). In all cases the observed recovery bias was found to be of no clinical significance.
2
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| CA 125 II ASSAY | ||||
|---|---|---|---|---|
| CA 125 II (06/18/02) | ||||
| and the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the commen |
| Interfering
Substance | Interfering Substance
Concentration
mg/dL | CA125
Concentration
(U/mL) | CA 125 II (06/18/
Effect
(% change) |
|---------------------------------|-------------------------------------------------|----------------------------------|-------------------------------------------|
| Hemoglobin | 1000 | 19.9 | -2.3 |
| Lipids (Triglycerides) | 1000 | 18.5 | 0.9 |
| Bilirubin | 25 | 22.5 | -2.6 |
| IgG | 6000 | 25.1 | -4.0 |
| Albumin | 6500 | 22.2 | 4.3 |
| Acetaminophen | 200 µg/mL | 30.9 | -0.5 |
| Aspirin | 500 µg/mL | 23.8 | -2.2 |
| Ibuprofen | 400 µg/mL | 23.8 | -0.8 |
| Caffeine | 100 µg/mL | 24.5 | 1.2 |
| Vitamin A | 10 U/mL | 21.6 | 0.1 |
| Vitamin B₁ | 3 µg/mL | 23.4 | -1.2 |
| Vitamin B₂ | 3.4 µg/mL | 21.6 | -1.3 |
| Vitamin B₆ | 4 µg/mL | 20.6 | -0.4 |
| Vitamin B₁₂ | 12 ng/mL | 21.6 | 9.5 |
| Vitamin C | 30 µg/mL | 24.5 | 1.4 |
| Vitamin D₂ | 0.8 U/mL | 20.6 | 3.7 |
| Vitamin E | 0.06 U/mL | 20.6 | 2.5 |
| Folic Acid | 0.8 µg/mL | 21.6 | 7.0 |
| Niacin | 40 µg/mL | 21.6 | 4.4 |
| Vincristine Sulfate | 13.5 | 20.6 | 4.1 |
| Vinblastine | 5.11 | 20.6 | 4.1 |
| Mitomycin C | 73 | 21.6 | 0.9 |
| Tamoxifen - Free | 60 | 20.6 | 4.1 |
| Tamoxifen - Citrate | 60 | 20.6 | 4.1 |
| Etoposide | 415 | 22.5 | 4.1 |
| 5-Fluorouracil | 1600 | 21.6 | 3.5 |
| Cyclophosphamide
Monohydrate | 800 | 21.6 | 0.9 |
| Doxorubicin HCl | 51.8 | 21.6 | 0.9 |
| Diethylstibestrol | 23 | 20.6 | 4.1 |
| Methotrexate | 450 | 22.5 | 5.6 |
| Cis-Platinum | 173 | 20.6 | 4.1 |
| Lupron | 15 | 25.9 | -5.8 |
| Megestrol Acetate | 243 | 21.6 | 0.9 |
Analytical Range
0.5 -- 550 U/mL
Minimum Detectable Concentration
| ADVIA IMS
(U/mL) | Immuno 1
(U/mL) |
|---------------------|--------------------|
| 0.5 | 0.9 |
3
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CA 125 II ASSAY CA 125 II (06/18/02)
4. Conclusion
Performance of the ADVIA IMS CA125 II Assay on a Bayer ADVIA® IMS™ is equivalent to the performance of the CA125 II Assay on the predicate device (Immuno 1) and is within proposed specifications. No safety and effectiveness issues have been raised.
Date
K. Edds Director Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097
PROPRIETARY and CONFIDENTIAL Bayer Corporation 511 Benedict Avenue Tarrytown, NY 10591-5097 USA
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Kenneth T. Edds, Ph.D. Regulatory Affairs Manager Bayer Diagnostics 511 Benedict Avenue Tarrytown, NY 10591
K022329 Re: Trade/Device Name: CA 125 II Assay for the ADVIA® IMSTM Regulation Number: 21 CFR 866.6010 Regulation Name: Tumor-associated antigen immunological test system Regulatory Class: Class II Product Code: LTK Dated: October 25, 2002 Received: October 29, 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).
5
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). 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 Sutman
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
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Page 1 of 1
510(k) Number: KO22329
Device Name: CA125 II Assay for the ADVIA® IMS™
Indications for Use:
The Bayer ADVIA® IMS™CA 125 II Assay is an in vitro diagnostic device intended to quantitatively measure OC 125 reactive determinants associated with a high molecular weight glycoprotein in serum of women with primary epithelial invasive ovarian cancer. The CA 125 II Assay is indicated as an aid in the management (monitoring) of ovarian cancer patients when used in conjunction with other diagnostic procedures. The CA 125 II Assay is also indicated as a one-time test for use as an aid in the detection of residual ovarian carcinoma in patients who have undergone first-line therapy and would be considered for diagnostic second-look procedures. An assay value of greater than 35 UlmL is predictive of residual disease, provided that alrernate causes of elevated CA 125 II Assay values can be excluded. It is recommended that the assessment and treatment of patients with ovarian cancer and the use of this CA 125 II Assay be under the order of a physician trained and experienced in the management of gynecologic cancers. This assay is not intended for screening or diagnosis of ovarian cancer or 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.L. Reeves for J. Bautista
Division of Clinical Laboratory Devices
510(k) Number: 1022329
510(k) Number
Prescription Use (Per 21 CFR 801.109) OR
Over-The-CounterUse
(Optional Format 1-2-96)