(76 days)
No
The description focuses on a fully automated immunoassay using chemiluminescent technology and specific antibodies/reagents. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
No
This device is an in vitro diagnostic test used to measure a cancer antigen in human serum, which aids in monitoring and managing breast cancer. It does not provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Chiron Diagnostics ACS:Centaur BR assay is an in vitro diagnostic test..."
No
The device description clearly outlines physical components like reagents (Lite Reagent, Solid Phase) and paramagnetic particles, indicating it is a hardware-based in vitro diagnostic test, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states that the assay is an "in vitro diagnostic test" and describes its use for analyzing human serum to aid in monitoring and managing breast cancer patients. This directly aligns with the definition of an IVD, which is used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details a laboratory-based assay that uses chemical and biological components (antibodies, paramagnetic particles) to measure a specific analyte (CA 27.29) in a sample (human serum). This is characteristic of an in vitro diagnostic test.
- Performance Studies: The document includes information about analytical performance characteristics like sensitivity and accuracy, which are standard evaluations for IVD devices.
- Predicate Device: The mention of a predicate device (K981698; ACS:180 BR Immunoassay) indicates that this device is being compared to a previously cleared IVD, further confirming its classification.
N/A
Intended Use / Indications for Use
The Chiron Diagnostics ACS:Centaur BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the Chiron Diagnostics ACS:Centaur" Automated Chemiluminescence System. The test is intended for use as an aid in monitoring patients previously treated for Stage Il or Stage III breast cancer. Serial testing for CA 27,25 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 breast cancer patients with metastatic disease by monitoring the progression or regression of disease in response to treatment.
Product codes
MOI
Device Description
The Chiron Diagnostics ACS:Centaur BR assay is a fully automated, competitive immunoassay using direct, chemiluminescent technology. The Lite Reagent is composed of a monoclonal mouse antibody specific for CA 27.29, labeled with acridinium ester. The antibody used in the assay, MAb B27,29, binds to a peptide epitope in the tandem repeat region of the MUC-1 gene product. The Solid Phase is composed of purified CA 27.29, which is covalently coupled to paramagnetic particles. After onboard pretreatment, the sample is incubated with both Lite Reagent and Solid Phase simultaneously for 7.5 minutes.
Mentions image processing
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Mentions AI, DNN, or ML
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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
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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
Accuracy: For 225 samples in the range of 6.54 to 448.94 U/mL, the relationship of the ACS:Centaur BR assay to the ACS:180 BR assay is described by the following equation: ACS:Centaur BR = 1.00 (ACS:180 BR) - 0.94 U/mL Correlation coefficient (r) = 0.99
Key Metrics
Sensitivity: The ACS:Centaur BR assay measures CA 27.29 concentrations up to 450 U/mL with a minimum detectable concentration (analytical sensitivity) of 3.5 U/mL.
Correlation coefficient (r) = 0.99
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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 1 5 1998
Summary of Safety and Effectiveness
As required by 21 CFR 807.92, the following 510(k) Summary is provided:
1. Submitter Information
number
| Contact person: | William J. Pignato |
|---|---|
| Address: | |
| 63 North Street | |
| Medfield, MA 02052 | Chiron Diagnostics Corporation |
| Phone: | |
| FAX: | |
| e-mail: | (508) 359-3825 |
| (508) 359-3885 | |
| william.pignato@chirondiag.com | |
| Date Summary Prepared: | July 28, 1998 |
| Device Information | |
| Proprietary Name: | |
| Common Name: | |
| Classification Name: | ACS:Centaur BR Immunoassay |
| CA 27.29 antigen Immunoassay | |
| Reclassified to Class II classification |
3. Predicate Device Information
| Name: | ACS:180 BR Immunoassay |
|---|---|
| Manufacturer: | Chiron Diagnostics |
| 510(k) Number: | K981698 |
4. Statement of Intended Use
The Chiron Diagnostics ACS:Centaur BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the Chiron Diagnostics ACS:Centaur" Automated Chemiluminescence System. The test is intended for use as an aid in monitoring patients previously treated for Stage Il or Stage III breast cancer. Serial testing for CA 27,25 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 breast cancer patients with metastatic disease by monitoring the progression or regression of disease in response to treatment.
unknown
6. Summary of Technological Characteristics
1
The Chiron Diagnostics ACS:Centaur BR assay is a fully automated, competitive immunoassay using direct, chemiluminescent technology. The Lite Reagent is composed of a monoclonal mouse antibody specific for CA 27.29, labeled with acridinium ester. The antibody used in the assay, MAb B27,29, binds to a peptide epitope in the tandem repeat region of the MUC-1 gene product. The Solid Phase is composed of purified CA 27.29, which is covalently coupled to paramagnetic particles. After onboard pretreatment, the sample is incubated with both Lite Reagent and Solid Phase simultaneously for 7.5 minutes.
7. Performance Data
Sensitivity
The ACS:Centaur BR assay measures CA 27.29 concentrations up to 450 U/mL with a minimum detectable concentration (analytical sensitivity) of 3.5 U/mL.
Accuracy
For 225 samples in the range of 6.54 to 448.94 U/mL, the relationship of the ACS:Centaur BR assay to the ACS:180 BR assay is described by the following equation:
ACS:Centaur BR = 1.00 (ACS:180 BR) - 0.94 U/mL Correlation coefficient (r) = 0.99
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with a serpent entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular pattern around the symbol.
OCT 1 5 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. William J. Pignato Director of Requlatory Affairs Chiron Diaqnostics Corporation 63 North Street Medfield, Massachusetts 02052
Re: K982680 ACS:Centaur BR Immunoassay Trade Name: Requlatory Class: İI Product Code: MOI Dated: July 28, 1998 Received: July 31, 1998
Dear Mr. Pignato:
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 Requlations, 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 Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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 obliqation 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.
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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 requlation (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" (21 CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Putman
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
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Company Confidential
Page of
510(k) Number (if known): h 953680
Device Name: Chiron Diagnostics ACS:Centaur BR Immunoassay
Indications for Use:
The Chiron Diagnostics ACS:Centaur BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the Chiron Diagnostics ACS:Centaur" Automated Chemiluminescence System. The test is intended for use as an aid in monitoring patients previously treated for Stage III breast cancer. Serial testing for CA 27.29 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 breast cancer patients with metastatic disease by monitoring the progression of disease in response to treatment.
Peter E. Maher
ivision Sign-Off Division of Clinical Laboratory Devices 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE--CONTINUE ON ANOTHER PAGE, IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
1 Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
ACS:Centaur BR 510(k)
28 July, 1998