(64 days)
P920030
Not Found
No
The device description and performance summary focus on a standard immunoassay technology and do not mention any AI or ML components.
No.
The device is an immunoassay for diagnosing conditions through laboratory measurements, not for treating or preventing disease.
Yes
The device quantitatively determines alpha-fetoprotein (AFP) in human serum and amniotic fluid, which is explicitly stated as an aid in detecting open neural defects and managing non-seminomatous testicular cancer. This indicates its use in identifying or monitoring disease states, which is the definition of a diagnostic device.
No
The device description clearly outlines a physical immunoassay kit with reagents and paramagnetic particles, which are hardware components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the quantitative determination of alpha-fetoprotein (AFP) in human serum and amniotic fluid. This involves testing samples taken from the human body.
- Device Description: The description details an immunoassay using antibodies to detect and measure a substance (AFP) in a sample. This is a common method for in vitro diagnostic tests.
- Performance Studies: The performance study describes the correlation between the ACS:Centaur AFP and another AFP immunoassay (ACS:180 AFP), which is a typical evaluation for an IVD.
- Predicate Device: The mention of a predicate device (ACS:180 AFP Immunoassay) with a K number (P920030) strongly indicates that this device is being compared to a previously cleared IVD.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of ACS:Centaur AFP Immunoassay is for the quantitative determination of alpha-fetoprotein (AFP) in the following:
- human serum and in amniotic fluid from specimens obtained at 15 to 20 weeks gestation, * as an aid in detecting open neural defects (NTD) when used in conjunction with ultrasonography and amniography testing,
- human serum, as an aid in managing non-seminomatous testicular cancer when used in * conjunction with physical examination, histology/pathology, and other clinical evaluation procedures, using the Chiron Diagnostics ACS:Centaur Automated Chemiluminescence System.
Product codes (comma separated list FDA assigned to the subject device)
LOQ
Device Description
The Chiron Diagnostics ACS:Centaur AFP immunoassay is a two-site immunoassay using direct chemiluminometric technology, which uses constant amounts of two antibodies. The first antibody, in the Lite Reagent, is a purified polyclonal rabbit anti-AFP antibody labeled with acridinium ester. The second antibody, in the Solid Phase, is a monoclonal mouse anti-AFP antibody covalently coupled to paramagnetic particles. A direct relationship exists between the amount of AFP present in the patient sample and the amount of relative light units (RLU's) detected by the system.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Sensitivity The ACS:Centaur AFP Immunoassay measures AFP concentration up to 1000 ng/mL with a minimum detectable concentration of 1.3 ng/mL.
Accuracy For 498 serum samples in the range of 2.0 to 943.6 ng/mL, the correlation between the ACS:Centaur AFP and the ACS:180 AFP is described by the equation: ACS:Centaur AFP = 1.05 (ACS:180 AFP) = - 0.3 ng/mL Correlation coefficient (r) = 0.99
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: minimum detectable concentration of 1.3 ng/mL
Accuracy (Correlation coefficient (r) = 0.99)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
P920030
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
7 1998 JUL
Company Confidential Summary of Safety and Effectiveness
As required by 21 CFR 807.92, the following 510(k) Summary is provided:
1. Submitter Information
Contact person:
Address:
Thomas F. Flynn
Chiron Diagnostics Corporation 63 North Street Medfield, MA 02052
Phone: (508) 359-3877 FAX: (508) 359-3885 e-mail: thomas flynn@chirondiag.com
Date Summary Prepared:
April 20, 1998
2. Device Information
Proprietary Name: Common Name: Classification Name: ACS:Centaur AFP AFP Immunoassay Reclassified to Class II, classification number unknown
3. Predicate Device Information
| Name: | ACS:180 AFP Immunoassay |
|---|---|
| Manufacturer: | Chiron Diagnostics |
| 510(k) Number: | P920030 (note reclassified to class II) |
4. Device Description
The Chiron Diagnostics ACS:Centaur AFP immunoassay is a two-site immunoassay using direct chemiluminometric technology, which uses constant amounts of two antibodies. The first antibody, in the Lite Reagent, is a purified polyclonal rabbit anti-AFP antibody labeled with acridinium ester. The second antibody, in the Solid Phase, is a monoclonal mouse anti-AFP antibody covalently coupled to paramagnetic particles. A direct relationship exists between the amount of AFP present in the patient sample and the amount of relative light units (RLU's) detected by the system.
1
Company Confidential
5. Statement of Intended Use
The intended use of ACS:Centaur AFP Immunoassay is for the quantitative determination of alpha-fetoprotein (AFP) in the following:
- human serum and in amniotic fluid from specimens obtained at 15 to 20 weeks gestation, * as an aid in detecting open neural defects (NTD) when used in conjunction with ultrasonography and amniography testing,
- human serum, as an aid in managing non-seminomatous testicular cancer when used in * conjunction with physical examination, histology/pathology, and other clinical evaluation procedures, using the Chiron Diagnostics ACS:Centaur Automated Chemiluminescence System.
Summary of Technological Characteristics દ.
The Chiron Diagnostics ACS:Centaur AFP Immunoassay is a two-site sandwich Chemiluminescence immunoassay.
Performance Data 7.
Sensitivity
The ACS:Centaur AFP Immunoassay measures AFP concentration up to 1000 ng/mL with a minimum detectable concentration of 1.3 ng/mL.
Accuracy
For 498 serum samples in the range of 2.0 to 943.6 ng/mL, the correlation between the ACS:Centaur AFP and the ACS:180 AFP is described by the equation:
ACS:Centaur AFP = 1.05 (ACS:180 AFP) = - 0.3 ng/mL
Correlation coefficient (r) = 0.99
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Thomas F. Flynn Manager, Requlatory Affairs & Compliance Chiron Diagnostics Corporation 63 North Street Medfield, Massachusetts 02052-1688
7 1998 JUL
Re : K981592 Trade Name: ACS: Centaur AFP Requlatory Class: II Product Code: LOQ Dated: April 30, 1998 Received: May 4, 1998
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 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 Regulations, 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 Regulations.
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Page 2
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 fitro 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/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): K981592
Device Name: Chiron Diagnostics ACS:Centaur AFP Immunoassay
Indications for Use:
10:39
The ACS:Centaur AFP Immunoassay is for the quantitative determination of alpha-fetoprotein (AFP) in the following:
- human serum, as an aid in managing non-seminomatous testicular cancer when used in * conjunction with physical examination, histology/pathology, and other clinical evaluation procedures, using the Chiron Diagnostics ACS:Centaur Automated Chemiluminescence System.
Pete E. Mason
Division of Clinical Laboratory I 510(k) Numbe
(PLEASE DO NOT WRITE BELOW THIS LINE--- CONTINUE ON ANOTHER PAGE, IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
Premarket Notification - 510(k) Chiron ACS:Centaur AFP Immunoassay
ACS:Centaur 510(k)
29 June, 1998