(70 days)
Not Found
No
The summary describes a standard in vitro diagnostic assay for measuring CA 125 levels using immunoassay technology. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices. The performance studies focus on analytical metrics of the assay itself.
No.
The device is an in vitro diagnostic (IVD) test for quantitative determination of CA 125, used as an aid in the management and monitoring of ovarian cancer, not for direct treatment or therapy.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the device is "For in vitro diagnostic use." It also describes its use in the "quantitative, serial determination of CA 125 in human serum and plasma" to "aid in the management of patients with ovarian carcinoma" and for "monitoring patients previously treated for ovarian cancer" and "monitoring the progression or regression of disease." These are all diagnostic applications.
No
The device description explicitly states it is comprised of "reagents," which are physical components, not software. The device is an in vitro diagnostic assay, which is a chemical test performed on biological samples.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use".
- Nature of the Test: The device performs a "quantitative, serial determination of CA 125 in human serum and plasma". This is a laboratory test performed on biological samples outside of the body, which is the definition of an in vitro diagnostic.
- Device Description: The description details reagents used to perform a chemical reaction on the sample, further confirming its in vitro nature.
N/A
Intended Use / Indications for Use
For in vitro diagnostic use in the quantitative, serial determination of CA 125 in human serum and plasma (EDTA and lithium heparin) and to aid in the management of patients with ovarian carcinoma using the ADVIA Centaur® XP and ADVIA Centaur® XPT systems. The test is intended for use as an aid in monitoring patients previously treated for ovarian cancer. Serial testing for CA 125 in the serum and plasma of patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early detection of cancer recurrence. The test is also intended for use as an aid in the management of ovarian cancer patients with metastatic disease by monitoring the progression or regression of disease in response to treatment. It is recommended that the ADVIA Centaur CA 125II assay be used under the order of a physician trained in the management of gynecological 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
The ADVIA Centaur CA 125Il assay is comprised of the following reagents:
CA 125II Lite Reagent: monoclonal mouse anti-M11 antibody (~0.15 µg/mL) labeled with acridinium ester and monoclonal mouse anti-OC 125 (~1.0 µg/mL) labeled with fluorescein in phosphate buffer with bovine serum albumin and preservatives (10.0 mL/pack).
CA 125II Solid Phase Reagent: monoclonal mouse anti-fluorescein antibody (~30 µg/mL) coupled to paramagnetic particles in phosphate buffer with bovine serum albumin and preservatives (25.0 mL/pack).
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
Prescription Use (Part 21 CFR 801 Subpart D).
It is recommended that the ADVIA Centaur CA 125II assay be used under the order of a physician trained and experienced in the management of gynecological cancers.
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
Study Type: Detection Limit.
Sample Size: Not specified, but determined in accordance with CLSI Document EP17-A2.
Key Results:
Limit of Blank (LoB): 2.0 U/mL
Limit of Detection (LoD): 3.0 U/mL
Limit of Quantitation (LoQ): 3.0 U/mL
The LoB corresponds to the highest measurement result that is likely to be observed for a blank sample with a probability of 95%.
The LoD corresponds to the lowest concentration of CA 125 that can be detected with a probability of 95%.
The LoQ corresponds to the lowest amount of CA 125 in a sample at which the within-laboratory CV is ≤ 20%.
Study Type: Method Comparison.
Sample Size: 224 samples.
Key Results: The relationship of the ADVIA Centaur CA 125Il assay to the Bayer Immuno 1® CA 125II assay is described by the following equation: ADVIA Centaur CA 125II = 1.025 (Bayer Immuno 1) + 1.15 U/mL. Correlation coefficient (r) = 0.992 for samples in the range of 3.1 to 466.6 U/mL.
Study Type: Specimen Equivalence.
Sample Size: Dipotassium EDTA plasma vs. Serum N=162; Lithium Heparin plasma vs. Serum N=119.
Data Source: Study performed in accordance with CLSI Document EP09-A3.
Key Results: Demonstrated that EDTA and Li-heparin plasma matrices yield comparable results as serum.
Dipotassium EDTA plasma (y) vs. Serum (x): Slope = 0.95 (95% CI: 0.92 - 0.98), Intercept = - 0.4 U/mL (95% CI: -1.5 – 0.7 U/mL), Correlation coefficient = 1.00 for sample interval 3.0 – 572.7 U/mL.
Lithium Heparin plasma (y) vs. Serum (x): Slope = 1.03 (95% CI: 0.97 – 1.08), Intercept = - 0.2 U/mL (95% CI: -1.8 – 1.4 U/mL), Correlation coefficient = 1.00 for sample interval 3.1 - 572.7 U/mL.
Study Type: Interferences.
Data Source: Interference testing performed in accordance with CLSI Document EP07-ed3.
Key Results:
Dipotassium EDTA (9.0 mg/mL) showed a bias of 3.7% at analyte concentration 39.6 U/mL and 1.3% at 526.5 U/mL.
Heparin (75 U/mL) showed a bias of 3.2% at analyte concentration 42.4 U/mL and -0.9% at 471.4 U/mL.
Key Metrics
Detection Limit:
LoB: 2.0 U/mL
LoD: 3.0 U/mL
LoQ: 3.0 U/mL
Method Comparison:
Correlation coefficient (r) = 0.992
Specimen Equivalence:
Correlation coefficient = 1.00 for both Dipotassium EDTA plasma vs. Serum and Lithium Heparin plasma vs. Serum.
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.
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April 6, 2020
Siemens Healthcare Diagnostics, Inc. Fatima Pacheco Regulatory Clinical Affairs Specialist 511 Benedict Ave. Tarrytown, New York 10591
Re: K200199
Trade/Device Name: ADVIA Centaur CA 125 II Assay Regulation Number: 21 CFR 866.6010 Regulation Name: Tumor-Associated Antigen Immunological Test System Regulatory Class: Class II Product Code: LTK Dated: January 24, 2020 Received: January 27, 2020
Dear Fatima Pacheco:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Carolina Kagan Acting Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200199
Device Name ADVIA Centaur® CA 125II
Indications for Use (Describe)
For in vitro diagnostic use in the quantitative, serial determination of CA 125 in human serum and plasma (EDTA and lithium heparin) and to aid in the management of patients with ovarian carcinoma using the ADVIA Centaur® XP and ADVIA Centaur® XPT systems. The test is intended for use as an aid in monitoring patients previously treated for ovarian cancer. Serial testing for CA 125 in the serum and plasma of patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early detection of cancer recurrence. The test is also intended for use as an aid in the management of ovarian cancer patients with metastatic disease by monitoring the progression or regression of disease in response to treatment. It is recommended that the ADVIA Centaur CA 125I assay be used under the order of a physician trained in the management of gynecological cancers. This assay is not intended for screening or diagnosis of ovarian cancer or for use on any other system.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary of Safety and Effectiveness for ADVIA Centaur® CA 12511
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
A. 510(k) Number: K200199
B. Purpose for Submission:
Modified Device - addition of plasma sample type
C. Applicant:
- Contact: Fatima Pacheco Regulatory Clinical Affairs Specialist
Address: Siemens Healthcare Diagnostics Inc. 511 Benedict Ave,
Tarrytown, NY 10591
(914) 374-3770 Phone:
-
Email: fatima.pacheco@siemens-healthineers.com
April 03, 2020 Date: -
D. Proprietary and Established Names: ADVIA Centaur® CA 125II
E. Measurand
Cancer Antigen 125 (CA 125)
F. Requlatory Information:
| Trade Name | ADVIA Centaur® CA 125II |
|---|---|
| Common Name | Chemiluminescence Immunoassay, for the |
| determination of CA 125 antigen | |
| Classification Name | Device to test, epithelial ovarian tumor-associated |
| antigen (ca125). | |
| FDA Classification | Class II |
| Review Panel | Immunology (82) |
| Product Code | LTK |
| Regulation Number | 21 CFR 866.6010 |
G. Predicate Devices:
Device Name: Bayer ADVIA Centaur CA 125II 510(k) Number: K020828
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H. Intended Use:
Same as Indications for Use
-Indications for Use:
For in vitro diagnostic use in the quantitative, serial determination of CA 125 in human serum and plasma (EDTA and lithium heparin) and to aid in the management of patients with ovarian carcinoma using the ADVIA Centaur® XP and ADVIA Centaur® XPT systems. The test is intended for use as an aid in monitoring patients previously treated for ovarian cancer. Serial testing for CA 125 in the serum and plasma of patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early detection of cancer recurrence. The test is also intended for use as an aid in the management of ovarian cancer patients with metastatic disease by monitoring the progression or regression of disease in response to treatment. It is recommended that the ADVIA Centaur CA 125ll assay be used under the order of a physician trained and experienced in the management of gynecological cancers. This assay is not intended for screening or diagnosis of ovarian cancer or for use on any other system.
J. Special Conditions for use statement(s):
For Prescription Use Only
K. Special Instrument Requirement:
For use on the ADVIA Centaur® XP and ADVIA Centaur XPT
L. Device Description:
The ADVIA Centaur CA 125Il assay is comprised of the following reagents:
| Component | Volume | Ingredients |
|---|---|---|
| CA 125II Lite Reagent | 10.0 mL/pack | monoclonal mouse anti-M11 antibody |
| (~0.15 µg/mL) labeled with acridinium ester and | ||
| monoclonal mouse anti-OC 125 (~1.0 µg/mL) | ||
| labeled with fluorescein in phosphate buffer with | ||
| bovine serum albumin and preservatives | ||
| CA 125II Solid Phase | ||
| Reagent | 25.0 mL/pack | monoclonal mouse anti-fluorescein antibody |
| (~30 µg/mL) coupled to paramagnetic particles in | ||
| phosphate buffer with bovine serum albumin and | ||
| preservatives |
M. Substantial Equivalence Information
The following table demonstrates substantial equivalence between the ADVIA Centaur 125ll assay (Candidate Device) with modified Package Insert (Instructions for Use) with the addition of plasma sample type (EDTA & Lithium Heparin) and the currently marketed ADVIA Centaur CA 125II (Predicate Device) that was cleared under 510 (k) K020828.
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| Trade Name | Candidate Device - Modified Labeling | Predicate Device - Current Labeling |
|---|---|---|
| ADVIA Centaur® CA 125II | ADVIA Centaur® CA 12511 | |
| Intended Use | For in vitro diagnostic use in the | |
| quantitative, serial determination | ||
| of CA 125 in human serum and | ||
| plasma (EDTA and lithium | ||
| heparin) and to aid in the | ||
| management of patients with | ||
| ovarian carcinoma using the | ||
| ADVIA Centaur® XP, and ADVIA | ||
| Centaur® XPT systems. The test | ||
| is intended for use as an aid in | ||
| monitoring patients previously | ||
| treated for ovarian cancer. Serial | ||
| testing for CA 125 in the serum | ||
| and plasma of patients who are | ||
| clinically free of disease should | ||
| be used in conjunction with other | ||
| clinical methods used for the | ||
| early detection of cancer | ||
| recurrence. The test is also | ||
| intended for use as an aid in the | ||
| management of ovarian cancer | ||
| patients with metastatic disease | ||
| by monitoring the progression or | ||
| regression of disease in response | ||
| to treatment. It is recommended | ||
| that the ADVIA Centaur CA 12511 | ||
| assay be used under the order of | ||
| a physician trained and | ||
| experienced in the management | ||
| of gynecological cancers. This | ||
| assay is not intended for | ||
| screening or diagnosis of ovarian | ||
| cancer or for use on any other | ||
| system. | For in vitro diagnostic use in the | |
| quantitative, serial | ||
| determination of CA 125 in | ||
| human serum and to aid in the | ||
| management of patients with | ||
| ovarian carcinoma using the | ||
| ADVIA Centaur®, ADVIA | ||
| Centaur XP, and ADVIA | ||
| Centaur XPT systems. The test | ||
| is intended for use as an aid in | ||
| monitoring patients previously | ||
| treated for ovarian cancer. | ||
| Serial testing for CA 125 in the | ||
| serum of patients who are | ||
| clinically free of disease should | ||
| be used in conjunction with | ||
| other clinical methods used for | ||
| the early detection of cancer | ||
| recurrence. The test is also | ||
| intended for use as an aid in | ||
| the management of ovarian | ||
| cancer patients with metastatic | ||
| disease by monitoring the | ||
| progression or regression of | ||
| disease in response to | ||
| treatment. It is recommended | ||
| that the ADVIA Centaur CA | ||
| 125ll assay be used under the | ||
| order of a physician trained and | ||
| experienced in the | ||
| management of gynecological | ||
| cancers. This assay is not | ||
| intended for screening or | ||
| diagnosis of ovarian cancer or | ||
| for use on any other system. | ||
| Analyte | Cancer Antigen 125 (CA 125) | Same |
| Automated | Automated assay | Same |
| Measurement | Quantitative | Same |
| Sample Type | Human Serum and Plasma | |
| (EDTA and Lithium Heparin) | Human Serum | |
| Detection Limit | LoB: 2.0 U/mL | |
| LoD: 3.0 U/mL | ||
| LoQ: 3.0 U/mL | Analytical Sensitivity: 2 U/mL | |
| Not Applicable | ||
| Not Applicable | ||
| Assay Measuring | ||
| Interval | 3.0 – 600 U/mL | 2 - 600 U/mL |
| Trade Name | Candidate Device - Modified | |
| Labeling | Predicate Device - Current | |
| Labeling | ||
| ADVIA Centaur® CA 125II | ADVIA Centaur® CA 125II | |
| Operating Principle | Sandwich | Sandwich |
| Technology | Direct Chemiluminescent | Same |
| Instrument | ADVIA Centaur Systems | Same |
| Sample Volume | 50 µL | 50 µL |
| Calibrators | ADVIA Centaur CA 125II | |
| Calibrator | Same | |
| Controls | Commercial Controls | Same |
| Detection Antibody | monoclonal mouse anti-M11 | |
| antibody (~0.15 µg/mL) labeled | ||
| with acridinium ester and | ||
| monoclonal mouse anti-OC 125 | ||
| (~1.0 µg/mL) labeled with | ||
| fluorescein | Same | |
| Capture Antibody | monoclonal mouse anti- | |
| fluorescein antibody (~30 µg/mL) | ||
| coupled to paramagnetic particles | Same |
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N. Test Principle
The ADVIA Centaur CA 125II assay is a two-site sandwich immunoassay using direct chemiluminometric technology, which uses two monoclonal mouse antibodies specific for CA 125. The first antibody is directed toward the M11 antigenic domain, and is labeled with acridinium ester. The second antibody is directed toward the OC 125 antigenic domain and is labeled with fluorescein. The immunocomplex formed with CA 125 is captured with monoclonal mouse anti-fluorescein antibody coupled to paramagnetic particles in the Solid Phase.
A direct relationship exists between the amount of CA 125 present in the patient sample and the amount of relative light units (RLUs) detected by the system.
O. Performance Characteristics
The assay principle, design and reagent formulation has not changed from the original device, therefore, the analytical performance studies and data previously reviewed under 510(K) K020828 continues to apply to this assay.
Detection Limit .
Detection capability was determined in accordance with CLSI Document EP17-A2.
| Limit of Blank (LoB) | 2.0 U/mL |
|---|---|
| Limit of Detection (LoD) | 3.0 U/mL |
| Limit of Quantitation (LoQ) | 3.0 U/mL |
The LoB corresponds to the highest measurement result that is likely to be observed for a blank sample with a probability of 95%.
The LoD corresponds to the lowest concentration of CA 125 that can be detected with a probability of 95%.
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The LoQ corresponds to the lowest amount of CA 125 in a sample at which the within-laboratory CV is ≤ 20%.
II. Method Comparison
For 224 samples in the range of 3.1 to 466.6 U/mL, the relationship of the ADV/A Centaur CA 125Il assay to the Bayer Immuno 1® CA 125II assay is described by the following equation:
ADVIA Centaur CA 125II = 1.025 (Bayer Immuno 1) + 1.15 U/mL
Correlation coefficient (r) = 0.992
Specimen Equivalence lll.
The study was performed in accordance with CLSI Document EP09-A3 to demonstrate that EDTA and Li-heparin plasma matrices yield comparable results as serum with the ADVIA Centaur CA 125 II assay. A Deming linear regression analysis was performed, and the corresponding slopes of regression and coefficient determination are summarized in the following table:
| Sample Type | N | Sample
Interval | Slope
(95% CI) | Intercept
(95% CI) | Correlation
coefficient |
|-------------------------------------------------|-----|---------------------|-----------------------|---------------------------------|----------------------------|
| Dipotassium EDTA
plasma (y) vs.
Serum (x) | 162 | 3.0 – 572.7
U/mL | 0.95
(0.92 - 0.98) | - 0.4 U/mL
(-1.5 – 0.7 U/mL) | 1.00 |
| Lithium Heparin
plasma (y) vs.
Serum (x) | 119 | 3.1 - 572.7
U/mL | 1.03
(0.97 – 1.08) | - 0.2 U/mL
(-1.8 – 1.4 U/mL) | 1.00 |
IV. Interferences: EDTA and Heparin
Interference testing was performed in accordance with CLSI Document EP07-ed3. The following results were obtained:
| Substance | Substance Test
Concentration | Analyte
Concentration
(U/mL) | Bias (%) |
|------------------|---------------------------------|------------------------------------|----------|
| Dipotassium EDTA | 9.0 mg/mL | 39.6 | 3.7 |
| | | 526.5 | 1.3 |
| Heparin | 75 U/mL | 42.4 | 3.2 |
| | | 471.4 | -0.9 |
P. Proposed Labeling
The labeling supports the finding of substantial equivalence for this device.
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Q. Conclusion
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.