(77 days)
P860044
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No
The description details a standard immunoassay based on electrochemiluminescence and a calibration curve. There is no mention of AI or ML algorithms being used for data analysis, interpretation, or result determination.
No.
The device is an in vitro diagnostic immunoassay that aids in the management of non-seminomatous germ cell tumors by quantifying α₁-fetoprotein in human serum and plasma, rather than directly treating or preventing disease.
Yes
The device quantitatively determines a biomarker in human samples to aid in managing specific cancer patients, which falls under the definition of a diagnostic device.
No
The device description clearly outlines a hardware-based immunoassay system involving reagents, microparticles, electrodes, and a photomultiplier for measurement. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states "Immunoassay for the in vitro quantitative determination of α₁-fetoprotein in human serum and plasma...". The phrase "in vitro" is the key indicator that the test is performed outside of the living body, which is the definition of an in vitro diagnostic.
- Sample Type: The test uses "human serum and plasma," which are biological samples taken from a patient.
- Purpose: The purpose is to "aid in the management of patients with non-seminomatous germ cell tumors," which is a diagnostic or monitoring purpose.
- Device Description: The description details a laboratory-based immunoassay process involving reagents, incubation, and measurement, all characteristic of an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
Immunoassay for the in vitro quantitative determination of α₁-fetoprotein in human serum and plasma to aid in the management of patients with non-seminomatous germ cell tumors. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Boehringer Mannheim Elecsys immunoassay analyzers.
Product codes
LOJ
Device Description
The Elecsys® test principle is based on the sandwich principle. Total duration of assay: 18 minutes. 1st incubation: 15 µl of sample, a biotinylated monoclonal AFP-specific antibody and a monoclonal AFP-specific antibody labeled with a ruthenium complex react to form a sandwich complex. 2nd incubation: after the addition of streptavidin-coated microparticles, the complex becomes bound to the solid phase via interaction of biotin and streptavidin. The reaction mixture is aspirated into the measuring cell where the micro-particles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier. Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent bar code.
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
Studies performed include: evaluation of assay precision according to NCCLS recommendations, determination of the lower detection limit, demonstration of linearity, correlation with the predicate device, evaluation of the effect of various endogenous substances (hemoglobin, biotin, triglyceride, lipemia, and rheumatoid factor), and commonly used pharmaceutical compounds and serum plasma sample comparisons. determination of hook effect, and stability studies. In addition, comparisons of the Elecsys AFP and the predicate device were performed with samples from serially monitored patients diagnosed and treated for testicular cancer.
Key Metrics
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Predicate Device(s)
P860044
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.
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| BOEHRINGER
MANNHEIM
| CORPORATION | |
|---|---|
| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. |
| 1) Submitter name, address, contact | Boehringer Mannheim Corporation
2400 Bisso Lane
Concord, CA 94524-4117
(317) 845-2000
Contact Person: Patricia M. Klimley
Date Prepared: September 2, 1997 |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2) Device name | Proprietary name: Elecsys® AFP
Common name: Alpha-Fetoprotein assay
Classification name: Alpha-Fetoprotein test kit for testicular cancer |
| 3) Predicate device | We claim substantial equivalence to the Enzymun-Test® AFP (P860044). |
| 4) Device Description | The Elecsys® test principle is based on the sandwich principle. Total duration of assay: 18 minutes. 1st incubation: 15 µl of sample, a biotinylated monoclonal AFP-specific antibody and a monoclonal AFP-specific antibody labeled with a ruthenium complex react to form a sandwich complex.2nd incubation: after the addition of streptavidin-coated microparticles, the complex becomes bound to the solid phase via interaction of biotin and streptavidin. |
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510(k) Summary, Continued
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| 4) Device Description, cont. | The reaction mixture is aspirated into the measuring cell where the micro- particles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier. Results are determined via a calibration curve which is instrument- specifically generated by 2-point calibration and a master curve provided via the reagent bar code. | |
|---|---|---|
| 5) Intended use | Immunoassay for the in vitro quantitative determination of α₁-fetoprotein in human serum and plasma to aid in the management of patients with non- seminomatous germ cell tumors. | |
| 6) Comparison to predicate device | The Boehringer Mannheim Elecsys AFP is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Enzymun-Test AFP. | |
| Studies performed include: evaluation of assay precision according to NCCLS recommendations determination of the lower detection limit demonstration of linearity correlation with the predicate device evaluation of the effect of various endogenous substances (hemoglobin, biotin, triglyceride, lipemia, and rheumatoid factor), and commonly used pharmaceutical compounds and serum plasma sample comparisons. determination of hook effect, and stability studies. In addition, comparisons of the Elecsys AFP and the predicate device were performed with samples from serially monitored patients diagnosed and treated for testicular cancer. |
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 2 1 1997
Ms. Patricia M. Klimley Manager, Requlatory Affairs Boehringer Mannheim Corporation 2400 Bisso Lane Concord, California 94524-4117
Re: K973351 Trade Name: Elecsys® AFP Regulatory Class: II Product Code: LOJ Dated: September 2, 1997 September 5, 1997 Received:
Dear Ms. Klimley:
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, 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 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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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 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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510(k) Number (if known): Device Name: Elecsys® AFP Indications for Use:
Immunoassay for the in vitro quantitative determination of &;-fetoprotein in human serum and plasma to aid in the management of patients with non-seminomatous germ cell tumors.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Boehringer Mannheim Elecsys immunoassay analyzers.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use__
(Optional Format 1-2-96)