(64 days)
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.
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.
Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Sensitivity (Minimum Detectable Concentration) | 1.3 ng/mL |
| Accuracy (Correlation with Predicate Device ACS:180 AFP) | ACS:Centaur AFP = 1.05 (ACS:180 AFP) = - 0.3 ng/mL |
| Correlation Coefficient (r) | 0.99 |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 498 serum samples
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The provided summary does not explicitly state the number of experts or their qualifications used to establish ground truth for the test set. The accuracy is reported as a correlation with a predicate device (ACS:180 AFP). This suggests that the "ground truth" for the test set was the results obtained from the predicate device, rather than a separate expert-driven ground truth establishment process.
4. Adjudication Method for the Test Set
No adjudication method is mentioned. The comparison is directly between the new device's readings and the predicate device's readings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
This information is not applicable. The device described (ACS:Centaur AFP Immunoassay) is a standalone diagnostic assay, not an AI-assisted interpretation tool for human readers. Therefore, no MRMC study or AI assistance effect size is relevant here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance assessment was done. The reported performance metrics (sensitivity, accuracy, correlation coefficient) are for the device (immunoassay system) operating independently to measure AFP concentration. There is no human-in-the-loop component described for these performance evaluations.
7. The Type of Ground Truth Used
The ground truth for the accuracy assessment was the results obtained from the predicate device, ACS:180 AFP Immunoassay. The study is essentially a comparison of the new device's measurements against an established, legally marketed device's measurements, assuming the predicate device provides a reliable measure of AFP.
8. The Sample Size for the Training Set
The document does not specify a training set or its sample size. This type of immunoassay development typically involves initial analytical validation and calibration, but the provided summary focuses on the performance comparison with the predicate device, which is more akin to a clinical validation set.
9. How the Ground Truth for the Training Set Was Established
Since no explicit training set is detailed, the method for establishing its ground truth is not provided. For an immunoassay, the "training" aspect would generally involve calibrating the system using known concentrations of AFP and optimizing reagents/protocols. The ground truth for this would be the known, prepared concentrations of AFP standards. However, the document doesn't detail this process.
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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.
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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
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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
§ 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.