(258 days)
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No
The description details a standard immunoassay technique (ELFA) and mentions automatic calculation based on a stored calibration curve, which is a typical function of automated laboratory instruments and does not indicate AI/ML. There are no mentions of AI, ML, or related concepts in the provided text.
No
This device is an in vitro diagnostic test that measures Carcinoembryonic antigen (CEA) levels to aid in monitoring cancer patients; it does not provide treatment or therapy.
Yes
The "Intended Use / Indications for Use" section states that the device is "an aid in the monitoring of cancer patients." While not a standalone diagnostic, aiding in monitoring is a diagnostic function, as it helps healthcare professionals assess patient status and disease progression, which directly informs clinical decision-making.
No
The device description clearly outlines physical components like the Solid Phase Receptacle (SPR) and reagent strips (STRs), and the assay principle involves chemical reactions and fluorescent detection, indicating it is a hardware-based in vitro diagnostic device with associated software for calculation and reporting.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative measurement of Carcinoembryonic antigen (CEA) in human serum." This involves testing a sample taken from the human body (in vitro) to provide diagnostic information.
- Device Description: The description details a laboratory-based assay using reagents and a specific technique (ELFA) to analyze the sample. This is characteristic of an in vitro diagnostic test.
- Clinical Comparison: The inclusion of a "Clinical Comparison" section, comparing the device's performance to a predicate device using patient samples, further confirms its use in a clinical diagnostic setting.
- Predicate Device: The mention of a "Predicate Device" which is also an "Enzyme Immunoassay" (a common type of IVD) strongly indicates that the VIDAS® CEA (S) is also an IVD.
The core function of the device is to analyze a biological sample (human serum) outside of the body to provide information about a specific analyte (CEA) that is used as an aid in monitoring cancer patients. This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
VIDAS® CEA (S) is an automated quantitative test for use on the VIDAS instruments, for the quantitative measurement of Carcinoembryonic antigen (CEA) in human serum using the ELFA technique (Enzyme Linked Fluorescent Assay). The VIDAS CEA (S) assay is indicated as an aid in the monitoring of cancer patients in whom changing concentrations of CEA are observed.
Product codes
DHX
Device Description
The assay principle combines a two-step immunoassay sandwich method with a final fluorescent detection (ELFA). The Solid Phase Receptacle (SPR), a pipette tip-like device, serves as the solid phase as well as the pipetting device for the assay. It is coated with anti-CEA monoclonal immunoglobulins (mouse). The other assay reagents are ready-to-use and pre-dispensed in the sealed reagent strips (STRs).
After dilution, the sample is transferred into the well containing CEA antibody (conjugate) labeled with alkaline phosphatase. The sample/conjugate mixture is cycled in and out of the SPR several times. This operation enables the antigen to bind with the immunoglobulins fixed to the interior wall of the SPR and to the conjugate to form a sandwich. Unbound compounds are eliminated during the first washing step.
A second incubation step is then performed with alkaline phosphatase-labeled anti-CEA polyclonal antibodies (goat). The unbound conjugate is then eliminated during washing steps.
During the final detection step, the substrate (4-Methyl-umbelliferyl phosphate) is cycled in and out of the SPR. The conjugate enzyme catalyzes the hydrolysis of this substrate into a fluorescent product (4-Methyl-umbelliferone) the fluorescence of which is measured at 450 nm. The intensity of the fluorescence is proportional to the concentration of antigen present in the sample. At the end of the assay, results are automatically calculated by the instrument in relation to the calibration curve stored in memory, and then printed out.
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
Non-clinical (Analytical) Comparison:
Intra-Assay Precision: n = 40 runs (across sites and lots). Pool C: Mean = 3.4 ng/mL, CV range = 2.7 - 4.4%. Pool B: Mean = 25 ng/mL, CV range = 3.5 - 4.4%. Pool A: Mean = 160 ng/mL, CV range = 3.7 - 5.3%.
Inter-Run Precision: n = 40 runs (across sites and lots). Pool C: Mean = 3.4 ng/mL, CV range = 0 - 1.3%. Pool B: Mean = 25 ng/mL, CV range = 0 - 1.6%. Pool A: Mean = 160 ng/mL, CV range = 0 - 1.0%.
Limits of Detection:
§ 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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Koroici4
510(k) SUMMARY
VIDAS® CEA (S) Assay
OCT 0 9 2008
A. Submitter Information
| Submitter's Name:
Address: | bioMérieux, Inc.
595 Anglum Road
Hazelwood, MO 63042 |
|--------------------------------------|------------------------------------------------------------|
| Contact Person: | Sandra Perreand |
| Phone Number: | 314-731-8594 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | September 29, 2008 |
| B. Device Name
Trade Name: | VIDAS® CEA (S) Assay |
| Common Name: | Carcinoembryonic Antigen |
| Classification Name: | System, Test, Carcinoembryonic Antigen |
C. Predicate Device Name
Trade Name:
B
Tosoh Medical, Inc. ST AIA Pack CEA Enzyme Immunoassay
D. Device Description
The assay principle combines a two-step immunoassay sandwich method with a final fluorescent detection (ELFA). The Solid Phase Receptacle (SPR), a pipette tip-like device, serves as the solid phase as well as the pipetting device for the assay. It is coated with anti-CEA monoclonal immunoglobulins (mouse). The other assay reagents are ready-to-use and pre-dispensed in the sealed reagent strips (STRs).
After dilution, the sample is transferred into the well containing CEA antibody (conjugate) labeled with alkaline phosphatase. The sample/conjugate mixture is cycled in and out of the SPR several times. This operation enables the antigen to bind with the immunoglobulins fixed to the interior wall of the SPR and to the conjugate to form a sandwich. Unbound compounds are eliminated during the first washing step.
A second incubation step is then performed with alkaline phosphatase-labeled anti-CEA polyclonal antibodies (goat). The unbound conjugate is then eliminated during washing steps.
During the final detection step, the substrate (4-Methyl-umbelliferyl phosphate) is cycled in and out of the SPR. The conjugate enzyme catalyzes the hydrolysis of this substrate into a fluorescent product (4-Methyl-umbelliferone) the fluorescence of which is measured at 450 nm. The intensity of the fluorescence is proportional to the concentration of antigen present in the sample. At the end of the assay, results are automatically calculated by the instrument in relation to the calibration curve stored in memory, and then printed out.
1
E. Intended Use
The VIDAS CEA (S) assay is VIDAS® CEA (S) is an automated quantitative test for use on the VIDAS instruments, for the quantitative measurement of Carcinoembryonic antigen (CEA) in human serum using the ELFA technique (Enzyme Linked Fluorescent Assay). The VIDAS CEA (S) assay is indicated as an aid in the monitoring of cancer patients in whom changing concentrations of CEA are observed.
F. Technological Characteristics Summary
A general comparison of the similarities and differences of the VIDAS CEA (S) assay to the predicate device is presented in the table below.
| Item | VIDAS® CEA (S) Assay | TOSOH ST AIA-PACK CEA
(K023893) |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General Comparison | | |
| Intended Use | VIDAS® CEA (S) is an automated
quantitative test for use on the VIDAS
instruments, for the quantitative
measurement of Carcinoembryonic
antigen (CEA) in human serum using
the ELFA technique (Enzyme Linked
Fluorescent Assay). The VIDAS CEA
(S) assay is indicated as an aid in the
monitoring of cancer patients in whom
changing concentrations of CEA are
observed. | ST AIA-PACK CEA is designed for
IN VITRO DIAGNOSTIC USE
ONLY for the quantitative
measurement of Carcinoembryonic
Antigen (CEA) in human serum to
aid in the management of cancer
patients in whom changing
concentrations of CEA are observed
on TOSOH AIA System analyzers. |
| Specimen | Serum | Serum |
| Analyte | Carcinoembryonic Antigen | Carcinoembryonic Antigen |
| Antibody | Goat polyclonal CEA antibody; mouse
monoclonal CEA antibody | Two mouse monoclonal CEA
antibodies |
| Assay Principle | Two antibody "sandwich" binding of CEA.
One antibody is bound to a solid phase and
the second antibody is in liquid form and is
labeled with fluorescent compound | Two antibody "sandwich" binding of
CEA. One antibody is bound to a
solid phase and the second antibody
is in liquid form and is labeled with
fluorescent compound |
| Automated | Yes | Yes |
| Assay Technique | Enzyme-linked fluorescent assay (ELFA) | Two-site immunoenzymometric
assay |
| Sample Volume | 200 µL | 100 µL |
| Traceability/
Standardization | Master curve for each kit lot and each
calibrator lot are traceable to reference
standards established by bioMérieux, Inc.
and the CarcinoEmbryonic Antigen 1st
International Reference Preparation
provided by the National Institute of
Biological Standards and Controls (NIBSC)
code 73/601 (1975) | Each calibrator lot are traceable to
WHO 1st International Reference
Preparation (IRP) 73/601 (1975) |
| Measurement range | 0.5 - 200 ng/mL | 0.5 - 100 ng/mL |
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G. Performance Data
A summary of the non-clinical and clinical test results is presented in the table below.
| Test | VIDAS® CEA (S) Assay | TOSOH ST AIA-PACK CEA
(K023894) |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Non-clinical (Analytical) Comparison | | |
| Intra-Assay Precision | n = 40 runs (across sites and lots)
Pool C:
Mean = 3.4 ng/mL
CV range = 2.7 - 4.4%
Pool B:
Mean = 25 ng/mL
CV range = 3.5 - 4.4%
Pool A:
Mean = 160 ng/mL
CV range = 3.7 - 5.3% | n = 20 replicates
Sample 1:
Mean = 4.56 ng/mL
CV = 4.3%
Sample 2:
Mean = 19.74 ng/mL
CV = 3.6%
Sample 3:
Mean = 45.64 ng/mL
CV = 4.0%
Sample 4:
Mean = 79.11 ng/mL
CV = 3.1% |
| Inter-Run Precision | n = 40 runs (across sites and lots)
Pool C:
Mean = 3.4 ng/mL
CV range = 0 - 1.3%
Pool B:
Mean = 25 ng/mL
CV range = 0 - 1.6%
Pool A:
Mean = 160 ng/mL
CV range = 0 - 1.0% | n = 20 runs
Sample 1:
Mean = 5.26 ng/mL
CV = 3.9%
Sample 2:
Mean = 22.81 ng/mL
CV = 3.3%
Sample 3:
Mean = 50.17 ng/mL
CV = 3.6%
Sample 4:
Mean = 91.52 ng/mL
CV = 3.2% |
| Limits of Detection |