Search Results

The Fujirebio Diagnostics CA 19-9™ RIA, an in vitro diagnostic test for the quantitative measurement of the CA 19-9 tumor associated antigen, in human serum or plasma, is indicated for the serial measurement of CA 19-9 to aid in the management of patients diagnosed with cancers of the exocrine pancreas. The test is useful as an aid in:

Monitoring of disease status in those patients having confirmed pancreatic cancer who have levels of serum or plasma CA 19-9 above the cutoff, at the time of diagnosis.

CA 19-9 values must be interpreted in conjunction with all other available clinical and laboratory data before a medical decision is determined.

The Fujirebio Diagnostics CA 19-9™ RIA is a solid-phase radioimmunoassay based on the forward sandwich principle. Polystyrene beads coated with a mouse monoclonal antibody against CA 19-9 are incubated with a serum or plasma specimen, or the appropriate standards or controls. During the incubation, the CA 19-9 antigen present in the specimen is specifically bound to the solid support by the mouse monoclonal antibody. Unbound material present in the specimen is removed by aspiration and washing of the beads. The same mouse monoclonal anti-CA 19-9 labeled with 1281 is then incubated with the beads and binds to the CA 19-9 antigen already bound to the beads. Unbound labeled antibody is removed by aspiration and washing. The bound radioactivity is determined by counting the beads in a gamma counter. A standard curve is obtained by plotting the CA 19-9 antigen concentration of the standards versus bound radioactivity. The CA 19-9 antigen concentrations of unknown patient specimens are determined from the standard curve and are directly proportional to the concentration of the bound tracer molecules.

The provided text describes the Fujirebio Diagnostics CA 19-9™ RIA, an in vitro diagnostic test. The acceptance criteria and supporting studies are presented across various performance characteristics.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: Specific "acceptance criteria" are not explicitly stated as distinct pass/fail thresholds in the document, but rather "acceptable ranges" or demonstrated performance that met the manufacturer's goals for substantial equivalence. The reported performance is taken directly from the study results.

2. Sample sizes used for the test set and the data provenance

• Analytical Sensitivity: No specific sample size mentioned for the determination of 0.9 U/mL.
• Interfering Substances: NCCLS guideline followed. Number of samples/substances tested not explicitly stated beyond "human anti-mouse antibodies" and "all other substances."
• Recovery Studies: 10 patient samples were used, spiked at three different levels. The provenance is not explicitly stated (e.g., country of origin) but implies human patient samples from clinical settings. It also states "acceptable percent Recovery Limits calculated using the precision of the assay diluent buffer," suggesting proprietary in-house data/methods.
• Linearity: 12 individuals with elevated CA 19-9 assay values were used.
• Reproducibility: Test materials were assayed identically across each lot of reagent. Three sites performed one run per day for 13 acceptable days. No specific number of patient samples is given, but likely controls and standards were used, possibly with patient samples for different concentrations.
• Clinical Data (Apparently Healthy Subjects): 200 women and 200 men (Total N=400). Provenance is not stated (e.g., country of origin, retrospective/prospective).
• Clinical Data (Benign Disease Cohorts): 399 benign disease patient cohorts (100 for GI, 99 for Genitourinary, 100 for Pancreas/Pancreatitis, 100 for Chronic Heart Disease/Hypertension). Provenance is not stated.
• Clinical Data (Monitoring Pancreatic Cancer): 61 patients with a total of 234 observations (average 3.84 observations per patient). Provenance is not stated.

All studies appear to be retrospective analyses of collected samples, as there is no mention of prospective enrollment or follow-up for the purpose of the study itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• No information is provided regarding the number or qualifications of experts used to establish ground truth for any of the studies.
• For the "Monitoring of Disease Status," "disease status" (Progressing, Stable, Responding) would typically be determined by clinical experts (e.g., oncologists, radiologists) based on imaging, biopsy results, and clinical evaluation, but this is not detailed.

4. Adjudication method for the test set

• No information is provided regarding any adjudication method used for establishing ground truth for any of the test sets.

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

• Not applicable. This device is an in vitro diagnostic (IVD) assay (a radioimmunoassay), not an AI-based image analysis or diagnostic support system that would involve human readers. Therefore, an MRMC study related to AI assistance for human readers was not performed.

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

• Yes, this entire submission describes standalone performance. The Fujirebio Diagnostics CA 19-9™ RIA is a laboratory test. Its performance characteristics (analytical sensitivity, recovery, linearity, reproducibility, and correlation with disease status from patient samples) are reported as the performance of the assay itself, without a human-in-the-loop component in the direct measurement and interpretation of the CA 19-9 values. The "intended use" explicitly states that CA 19-9 values "must be interpreted in conjunction with all other available clinical and laboratory data before a medical decision is determined," indicating the test provides quantitative data to be used by clinicians, not a definitive human-independent diagnosis.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Analytical Ground Truth: For analytical studies (sensitivity, recovery, linearity, reproducibility), the "ground truth" refers to known concentrations of CA 19-9 antigen (standards, spiked samples) or expected values based on dilution.
• Clinical Ground Truth:
  • Healthy Subjects: Ground truth was "apparently disease free" status, likely based on medical history and general health checks.
  • Benign Disease Cohorts: Ground truth was diagnosis of specific benign diseases (e.g., "Benign Diseases of the Genitourinary Tract," "Benign Diseases of the Pancreas/Pancreatitis"). These diagnoses would typically be made through standard clinical diagnostic procedures (imaging, biopsies, clinical assessment, patient history).
  • Monitoring Pancreatic Cancer: Ground truth for "disease status" (Progressive, Stable, Responding) was determined from clinical assessment over time (changes in signs and symptoms). This would likely involve a combination of clinical observations, imaging studies, and possibly biopsy results overseen by treating physicians. No specific details are provided on how these states were definitively confirmed.

8. The sample size for the training set

• Not applicable. This device is a traditional RIA laboratory test, not a machine learning or AI model. Therefore, there is no "training set" in the context of AI. The methods described are part of traditional assay development and validation.

9. How the ground truth for the training set was established

• Not applicable, as there is no training set.

Ask a specific question about this device