(92 days)
No
The summary describes a standard automated immunoassay analyzer with functions like sample handling, reagent addition, incubation, and data reduction. There is no mention of AI, ML, or related concepts.
No.
The device is described as an automated immunoassay analyzer designed to perform in vitro diagnostic immunochemical assays, which means it is used for diagnosis, not therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "designed to perform in vitro diagnostic immunochemical assays analysis on clinical specimens".
No
The device description clearly outlines hardware components and functions such as aspirating, dispensing, incubating, separating waste, and measuring photon emissions, indicating it is a physical analyzer system, not software only.
Yes, based on the provided information, the ACS:Centaur system is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the system is "designed to perform in vitro diagnostic immunochemical assays analysis on clinical specimens." This is the primary definition of an IVD device.
- Device Description: The description details how the system processes clinical specimens (aspirates, dispenses, adds reagents, incubates, measures emissions, performs data reduction) to perform these assays. This aligns with the functions of an IVD analyzer.
- Predicate Device: The mention of a predicate device with a K number (K902336) and the name "ACS:180® Analyzer" strongly suggests that this device is being submitted for regulatory review as an IVD, as predicate devices are used for comparison in the regulatory process for new IVDs.
Therefore, the information clearly indicates that the ACS:Centaur system is intended for and functions as an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the ACS:Centaur system is an automated immunoassay analyzer designed to perform in vitro diagnostic immunochemical assays analysis on clinical specimens using the ACS ilmmunoassays. The system menu will include endocrine, anemia, reproductive, cardiac, therapeutic drug, and infectious disease assays. All assays are based on chemiluminescent technology.
Product codes
JJE
Device Description
The ACS:Centaur system is a stand-alone, continuous operation, immunochemistry analyzer. The system performs the following functions.
- aspirates and dispenses samples .
- . performs dilutions
- adds reagents .
- incubates reaction vessels .
- separates solid and liquid waste .
- measures photon emissions .
- performs data reduction .
- collects and maintains patient demographics and results .
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
D.C. #K902336.
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
K4 111418
7 1097
ACS Centaur
Summary of Safety and Effectiveness
As required by 21 CFR 807.92, the following 510(k) Summary is provided:
1. Submitters Information
| Contact person: | William J. Pignato
Director of Regulatory Affairs |
|-----------------|-------------------------------------------------------------------------|
| Address: | Chiron Diagnostics Corporation
63 North Street
Medfield, MA 02052 |
| Phone: | 508 359-3825 |
April 14, 1997 Date Summary Prepared:
2. Device Information
| Proprietary Name: | ACS:Centaur Analyzer |
|---|---|
| Common Name: | Automated Immunoassay Analyzer |
| Classification Name: | Photometric Analyzer for Clinical Use |
| Classification Number: | 21 CFR 862.2160, Class I |
3. Predicate Device Information
| Name: | ACS:180® Analyzer |
|---|---|
| Manufacturer: | Chiron Diagnostics Corporation (formally Ciba Corning Diagnostics Corp.) |
| 510(k) Number: | D.C. #K902336. |
4. Device Description
The ACS:Centaur system is a stand-alone, continuous operation, immunochemistry analyzer. The system performs the following functions.
- aspirates and dispenses samples .
- . performs dilutions
- adds reagents .
- incubates reaction vessels .
- separates solid and liquid waste .
- measures photon emissions .
- performs data reduction .
- collects and maintains patient demographics and results .
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5. Statement of Intended Use
The intended use of the ACS:Centaur system is an automated immunoassay analyzer designed to perform in vitro diagnostic immunochemical assays analysis on clinical specimens using the ACS ilmmunoassays. The system menu will include endocrine, anemia, reproductive, cardiac, therapeutic drug, and infectious disease assays. All assays are based on chemiluminescent technology.
6. Summary of Technological Characteristics
ACS assays are dedicated for use on the ACS:180® and the ACS:Centaur utilizes acridinium ester as label and paramagnetic particles as the solid phase. Like the ACS:180®, the ACS:Centaur measures the amount of light emitted during the chemiluminescent reaction. There is direct relationship between the amount of light emitted and amount of antigen in the patient sample. The system will measure both competitive binding assavs and sandwich assays.
The ACS:Centaur system uses a Master Curve and a two-point, user-initiated calibration to calibrate all the ACS assays. TThe Master Curve and the two-point calibration system eliminate the need to measure a full standard curve with each assay or to run calibrators each time the assay is run. The system stores the calibration for the interval specified in the assay product inserts.
Other Technological Features include:
- Photomultiplier used in the photon counting mode .
- Automated pipetting of sample and reagents ●
- Electronic Fluid Sensing on sample and reagents ●
- Clog detection for samples ●
- Random access and batch test processing ●
- . Varied test incubations
- . Human Interface features including barcode reading, LIS, automated data reduction.
- Automated dilution capabilities ●
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of a human figure, with three overlapping profiles. The profiles are facing to the right and are connected by flowing lines.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 17 1997
Thomas F. Flynn
Manager, Requlatory Affairs & Compliance Chiron Diagnostics Corporation 63 North Street Medfield, Massachusetts 02052-1688
Re : K971418 ACS Centaur Analyzer Regulatory Class: I Product Code: JJE June 26, 1997 Dated: Received: June 27, 1997
Dear Mr. Flynn:
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 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, 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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation 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 obligation 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 Requlations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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" (21 CFR 807.97). Other general 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/dsmamain.html".
Sincerely yours,
Steven Gutman
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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Page __ of ___________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Chiron Diagnostics ACS:Centaur System ___________________________________________________________________________________________________________________________
Indications for Use:
The intended use of the ACS:Centaur system is an automated immunoassay analyzer The Intended use of the AOO.OChiaan of chamical assays analysis on clinical specimens using the ACS ilmmunoassays. The system menu will include endorine, specificals using the AOO minimanedation drug, and infectious disease assays. All anemia, reproductive, "Cardiac, therefound and is an indirect indicator of thyroid status.4
| (Division Sign-Off) |
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| Division of Clinical Laboratory Leviges |
| 510(k) Number |
(PLEASE DO NOT WRITE BELOW THIS LINE--CONTINUE ON ANOTHER PAGE, IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _ (Optional Format 1-2-96)
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