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DPC's IMMULITE CEA is intended for use with the IMMULITE Automated Immunoassay Analyzer. The IMMULITE CEA is a solid-phase, chemiluminescent enzyme immunoassay designed for the quantitative detection of carcinoembryonic antigen in human serum. It is intended strictly for in vitro diagnostic use as an aid in the management of cancer patients and in the assessment of prognosis.

IMMULITE CEA is a clinical device for use with the IMMULITE Automated Immunoassay Analyzer. IMMULITE CEA is designed for the quantitative detection of carcinoembryonic antigen in human serum. It is intended strictly for in vitro diagnostic use as an aid in the management of cancer patients and in the assessment of prognosis. DPC's IMMULITE CEA is an in vitro diagnostic medical device for use with DPC's IMMULITE Automated Immunoassay Analyzer, a random access instrument which performs chemiluminescent immunoassays. The assay is designed for the quantitative measurement of carcinoembryonic antigen (CEA) in serum and is intended as an aid in the management of patients with cancer and in the assessment of prognosis. The IMMULITE CEA assay is a solid-phase, two-site sequential chemiluminescent immunometric assay. The solid phase consists of a polystyrene bead (coated with a monoclonal antibody specific for CEA) which is enclosed within an IMMULITE Test Unit (LCE1) which acts as a reaction vessel. The patient serum sample (or CEA Adjustors, LCEL and LCEH) and reagent (LCEA, buffer/serum matrix, with preservative) are incubated for approximately 30 minutes at 37℃ in the Test Unit. With intermittent agitation, CEA in the sample becomes bound to the surface of the bead. Unbound serum is then removed by a centrifugal wash. A second reagent (LCEB, an alkaline phosphatase-labeled anti-ligand) is introduced and the Test Unit is incubated for an additional 30 minutes. Unbound conjugate is removed by a centrifugal wash, after which a chemiluminescent substrate (LSUB, a phosphate ester of adamantyl dioxetane) is added and the Test Unit is incubated for a further 10 minutes. The substrate undergoes hydrolysis in the presence of alkaline phosphatase to yield an unstable intermediate. The continuous production of this intermediate results in the sustained emission of light. The bound complex (and thus also the photon output as measured by the luminometer) is proportional to the concentration of CEA in the sample. The concentration of CEA in the patient sample is obtained using a stored master calibration curve within the IMMULITE analyzer. The IMMULITE CEA assay has a calibration range up to 550 nanograms of CEA per milliliter.

The provided text describes the IMMULITE® CEA device, a chemiluminescent immunoassay for quantitative detection of carcinoembryonic antigen (CEA) in human serum, intended as an aid in cancer patient management and prognosis assessment. The submission is a 510(k) summary for premarket notification, asserting substantial equivalence to the Abbott IMx® CEA kit.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" in a numerical or categorical format. Instead, the basis for acceptance is stated as "substantial equivalence" to a predicate device. The performance is demonstrated through a method comparison study.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: 374 specimens
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). It is simply referred to as "specimens."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

This information is not provided in the document. The "ground truth" for the method comparison study was the results obtained from the predicate device, Abbott IMx® CEA.

4. Adjudication Method for the Test Set:

This information is not applicable/provided. The comparison was between two automated assay systems, not involving human expert adjudication in the traditional sense of diagnostic imaging or clinical assessment. The predicate device's results served as the reference.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable. The device is an in vitro diagnostic immunoassay, not an AI-assisted diagnostic imaging tool that involves human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Yes, essentially. The study described is a comparison of the IMMULITE® CEA assay (an automated system) against the Abbott IMx® CEA assay (also an automated system). Both systems operate without "human-in-the-loop" performance in the interpretive sense, although human operators perform the tests. The performance metrics (linear regression, correlation coefficient) reflect the standalone analytical performance of the IMMULITE® CEA device compared to an established method.

7. The Type of Ground Truth Used:

The "ground truth" for this comparative study was the measurement of CEA in human serum using the legally marketed predicate device, Abbott IMx® CEA. This is a form of "reference method" comparison.

8. The Sample Size for the Training Set:

This information is not provided in the document. The summary focuses on the comparative study for substantial equivalence, not the internal development or training of the IMMULITE® CEA assay.

9. How the Ground Truth for the Training Set was Established:

This information is not provided. As above, the document details the comparative study against a predicate device, not the development process of the IMMULITE® CEA assay itself, which would involve its own calibration and validation.

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