(53 days)
Not Found
No
The summary describes a standard in vitro diagnostic immunoassay for measuring a specific cancer antigen. There is no mention of AI, ML, image processing, or any computational analysis beyond basic quantitative measurements and statistical analysis of performance characteristics.
No
The device is described as an in vitro diagnostic test for measuring CA 15-3 levels, used for monitoring disease course and recurrence in breast cancer patients, which is a diagnostic function, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The ADVIA Centaur CA 15-3 assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 15-3 in human serum and plasma." It further elaborates its use for "monitoring the course of disease and therapy in metastatic breast cancer patients, and for detection of recurrence." These statements clearly indicate its purpose in diagnosing and monitoring a disease.
No
The device description clearly outlines physical reagent packs and components, indicating it is a hardware-based in vitro diagnostic test, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The ADVIA Centaur CA 15-3 assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 15-3 in human serum and plasma..." This directly identifies the device as an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The ADVIA Centaur CA 15-3 assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 15-3 in human serum and plasma (EDTA and lithium heparin) using the ADVIA Centaur XP, and ADVIA Centaur XPT systems. When used in conjunction with other clinical and diagnostic procedures, serial testing with the ADVIA Centaur CA 15-3 assay is useful for monitoring the course of disease and therapy in metastatic breast cancer patients, and for detection of recurrence in previously treated Stage II, with greater than two positive lymph nodes, or Stage III breast cancer patients. This assay is not intended for use on any other system.
Product codes (comma separated list FDA assigned to the subject device)
MOI
Device Description
The ADVIA Centaur CA 15-3 assay reagents come in the following configurations:
- 5 ReadyPack primary reagent packs containing ADVIA Centaur CA 15-3 Lite Reagent, Solid Phase, and Conjugate Reagent ADVIA Centaur CA 15-3 Master Curve card (500 Tests)
- 1 ReadyPack primary reagent pack containing ADVIA Centaur CA 15-3 Lite Reagent, Solid Phase, and Conjugate Reagent ADVIA Centaur CA 15-3 Master Curve card (100 Tests)
The ReadyPack consists of the following:
- ADVIA Centaur CA 15-3 ReadyPack® primary reagent pack; Lite Reagent: 5.0 mL/reagent pack monoclonal mouse anti-DF3 antibody (~ 2.0 µg/mL) labeled with acridinium ester in buffered saline with bovine serum albumin, sodium azide (
§ 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
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
November 22, 2019
Siemens Healthcare Diagnostics, Inc. Anoop Jov Regulatory Affairs Specialist 511 Benedict Avenue Tarrytown, New York 10591
Re: K192777
Trade/Device Name: ADVIA Centaur CA 15-3 assay Regulation Number: 21 CFR 866.6010 Regulation Name: Tumor-Associated Antigen Immunological Test System Regulatory Class: Class II Product Code: MOI Dated: September 27, 2019 Received: September 30, 2019
Dear Anoop Joy:
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,
Takeesha Taylor-Bell Acting Deputy Division Director Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192777
Device Name ADVIA Centaur CA 15-3 assay
Indications for Use (Describe)
The ADVIA Centaur CA 15-3 assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 15-3 in human serum and plasma (EDTA and lithium heparin) using the ADVIA Centaur XP, and ADVIA Centaur XPT systems. When used in conjunction with other clinical and diagnostic procedures, serial testing with the ADVIA Centaur CA 15-3 assay is useful for monitoring the course of disease and therapy in metastatic breast cancer patients, and for detection of recurrence in previously treated Stage II, with greater than two positive lymph nodes, or Stage III breast cancer patients. This assay is not intended for use on any other system.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary of Safety and Effectiveness
ADVIA Centaur CA 15-3 assay
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.
The assigned 510(k) Number: K192777
. APPLICANT
Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue, Tarrytown, NY 10591 USA
| Contact: | Anoop Joy |
|---|---|
| Regulatory Clinical Affairs Specialist | |
| Phone: | (914) 524-2273 |
| Fax: | (914) 524-2101 |
| E-mail: | anoop.joy@siemens-healthineers.com |
Date Prepared: November 21, 2019
II. Regulatory Information
Name of Device: ADVIA Centaur CA 15-3 Classification: Class II Regulation Section: 21 CFR § 866.6010 Product Code: MOI Panel: Immunology
lll. PREDICATE DEVICE
Name of Device: ADVIA Centaur CA 15-3 assay 510 (k): K012357
4
DEVICE DESCRIPTION IV.
The ADVIA Centaur CA 15-3 assay reagents come in the following configurations:
| Contents | Number of Tests |
|---|---|
| 5 ReadyPack primary reagent packs containing ADVIA Centaur | |
| CA 15-3 Lite Reagent, Solid Phase, and Conjugate Reagent | |
| ADVIA Centaur CA 15-3 Master Curve card | 500 |
| 1 ReadyPack primary reagent pack containing ADVIA Centaur | |
| CA 15-3 Lite Reagent, Solid Phase, and Conjugate Reagent | |
| ADVIA Centaur CA 15-3 Master Curve card | 100 |
The ReadyPack consists of the following:
ADVIA Centaur CA 15-3 ReadyPack® primary reagent pack; Lite Reagent
5.0 mL/reagent pack monoclonal mouse anti-DF3 antibody (~ 2.0 µg/mL) labeled with acridinium ester in buffered saline with bovine serum albumin, sodium azide (