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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.

Device Description

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.

AI/ML Overview

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.

Performance Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance
Analytical Sensitivity	Below the established clinical cut-off of 37 U/mL.	0.9 U/mL.
Interfering Substances	Minimal or no interference from common substances at tested levels. Potentially high concentrations of HAMA might interfere, but lower concentrations should not.	Only human anti-mouse antibodies (HAMA) at a high titer of 16,636 showed potential interference. HAMA at a lower titer of 1664 showed no effect. All other tested substances showed no interference at tested levels.
Recovery Studies	Percent recoveries should fall within calculated acceptable limits for different spike levels. (Low: 87.9 - 112.1%; Mid: 81.9 - 118%; High: 93.0 - 107.0%)	Low Spike (approx. 8 U/mL): Mean 108.34%. Individual sample recoveries ranged from 92.31% to 121.37%. One sample (Patient 4: 121.37%) slightly exceeded the upper limit.
Mid Spike (approx. 29 U/mL): Mean 101.91%. Individual sample recoveries ranged from 97.75% to 103.42%. All fell within the limits.
High Spike (approx. 90 U/mL): Mean 101.13%. Individual sample recoveries ranged from 96.49% to 111.58%. One sample (Patient 1: 111.58%) slightly exceeded the upper limit.
Linearity	Mean slope close to 1 and mean y-intercept close to 0 in regression analysis of observed vs. expected CA 19-9 values.	Mean slope: 0.96 ± 0.031. Mean y-intercept: 5.97 ± 7.65.
Reproducibility	Total average variability and intra-assay variation should be within acceptable limits, especially for concentrations at or above the clinical cut-off. High variability is acceptable for very low concentrations.	Total average variability ranged from 6.7% (44 U/mL) to 15.4% (8 U/mL). Day-to-day variation peaked at 14.9% CV. Maximum intra-assay variation was 18% at 8 U/mL (below first non-zero calibrator and clinical cut-off). Average intra-assay variation for 8 U/mL was 12.5% CV. For all other concentrations, average intra-assay variation did not exceed 6.5% CV.
Clinical Distribution	Most apparently healthy subjects should be below the 37 U/mL cut-off. Distribution in benign disease cohorts should show that a significant portion remains below the cut-off, though some may exceed it.	Healthy Subjects (N=400): 93.75% 37 U/mL (e.g., 1% of males and 0.5% of females > 100 U/mL).
Benign Diseases (N=399):
Genitourinary Tract: 90.9%

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