(163 days)
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:
| Performance Aspect | Acceptance Criteria (Implicit/Demonstrated Equivalence) | Reported Device Performance (IMMULITE® OM-MA) |
|---|---|---|
| Clinical Association with Ovarian Cancer Status | Demonstrate significant association between CA 125 levels and clinical status (regression, stable, progression). | Chi-squared test: χ² = 50.7, df = 4, p |
§ 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.