Search Results

IMMULITE OM-MA is a chemiluminescent enzyme immunometric assay for use with the IMMULITE Automated Analyzer and designed for the quantitative measurement of CA 125 antigen in serum. It is intended strictly for in vitro diagnostic use as an aid in monitoring the response to therapy for patients with epithelial ovarian cancer, and in detecting residual ovarian cancer in patients who have undergone first-line therapy and would be considered for diagnostic second-look procedures.

IMMULITE® OM-MA is a clinical device for use with the IMMULITE Automated Immuno-assay Analyzer. IMMULITE OM-MA is a solid-phase, chemiluminescent immunometric assay. The solid phase, a polystyrene bead enclosed within an IMMULITE Test Unit, is coated with a murine monoclonal antibody specific for CA 125. The patient sample and alkaline phosphatase conjugated rabbit polyclonal anti-CA 125 antibody (Reagent A) are incubated for approximately 60 minutes in the Test Unit, with intermittent agitation. Reagent B, consisting of a buffer with preservative, is added after the first 30-minute cycle. CA 125 in the sample is bound to form an antibody sandwich complex. Unbound enzyme conjugate is then removed by a centrifingal wash, after which substrate is added and the Test Unit is incubated for a further 10 minutes. The chemiluminescent substrate, a phosphate ester of adamantyl dioxetane, undergoes hydrolysis in the presence of alkaline phosphatase to vield an unstable intermediate. The continuous production of this intermediate results in the sustained emission of light, thus improving precision by providing a window for multiple readings. The bound complex - and thus also the photon output, as measured by the luminometer - is proportional to the concentration of CA 125 in the sample.

Here's a breakdown of the acceptance criteria and study details for the IMMULITE® OM-MA device, based on the provided text:

Acceptance Criteria and Device Performance

The provided text focuses on demonstrating the substantial equivalence of the IMMULITE® OM-MA to a legally marketed predicate device (Centocor® CA 125 II RIA) for its intended use, rather than explicitly listing pre-defined "acceptance criteria" as pass/fail thresholds. Instead, the performance data is presented to show correlation and clinical utility.

Table of Performance Comparison:

Study Details:

1. Sample Size used for the test set and the data provenance:

   • Clinical Association Study: 30 serially monitored ovarian cancer patients, providing between 4 and 41 serial specimens over the course of their disease.
     • Provenance: "two clinical sites in the United States."
     • Retrospective/Prospective: The serial monitoring of patients suggests a prospective collection of samples based on their disease course, although the exact design (e.g., initial patient enrollment) is not fully detailed.
   • Method Comparison Study: 165 samples.
     • Provenance: "healthy male and female individuals (ranging from 17 to 80 years of age), and also from patients with ovarian carcinoma and other malignant diseases (ranging from 26 to 81 years of age)." The country of origin for these samples is not explicitly stated but is implicitly the U.S. as the clinical performance evaluation was conducted in two U.S. clinical sites.
     • Retrospective/Prospective: Not explicitly stated, but clinical samples are often collected retrospectively for such comparisons.

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

   • The document does not specify the number of experts or their qualifications for establishing the "clinical status" (regression, stable, progression) which served as the ground truth for the clinical association study. It only mentions "clinical status."

3. Adjudication method for the test set:

   • Not specified. The document only refers to "clinical status" without detailing how this status was determined or adjudicated by experts.

4. 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:

   • No, an MRMC study was not done. This device is an in vitro diagnostic (IVD) immunoassay for quantitative measurement of a biomarker (CA125), not an imaging or diagnostic device that involves human reader interpretation with or without AI assistance.

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

   • Yes, the performance presented for the IMMULITE® OM-MA is standalone. It's an automated immunoassay where the device itself measures the CA125 antigen and provides a quantitative result without human intervention in the measurement process, aside from sample loading and result interpretation.

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

   • For the clinical association study, the ground truth was clinical status (regression, stable, progression), which would typically be determined by physician assessment based on various clinical parameters, imaging, and patient outcomes over time.
   • For the method comparison study, the ground truth was the measurement by the predicate device (Centocor® CA 125 II RIA), against which the new device's measurements were compared.

7. The sample size for the training set:

   • The document does not explicitly mention a "training set" in the context of machine learning or algorithm development for the IMMULITE® OM-MA assay. This is a chemical immunoassay, not a device that uses a trained AI model in the conventional sense. The "training" in this context would refer to the assay's internal calibration and optimization during development, which is not detailed in terms of sample size or methodology.

8. How the ground truth for the training set was established:

   • As noted above, the concept of a "training set" and associated "ground truth" for model training is not directly applicable in the sense of machine learning for this immunoassay device. The device's calibration and assay parameters would have been established using reference materials and standards, following standard laboratory practices for IVDs, but these details are not provided in this regulatory summary.

Ask a specific question about this device