(163 days)
P85009/S001- S007
P85009/S001- S007
No
The device description details a standard chemiluminescent immunoassay process, which is a biochemical method for measuring substances. There is no mention of AI, ML, or any computational algorithms beyond basic data processing for calculating concentration based on light emission.
No
The device is explicitly stated for "in vitro diagnostic use as an aid in monitoring the response to therapy," meaning it helps diagnose or monitor a condition and does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states, "It is intended strictly for in vitro diagnostic use."
No
The device description clearly outlines a physical assay kit (solid-phase, chemiluminescent immunometric assay) with reagents and a polystyrene bead, designed for use with a specific hardware analyzer. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "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."
This statement clearly indicates that the device is designed to be used outside of the body (in vitro) to diagnose or aid in the diagnosis or monitoring of a medical condition.
N/A
Intended Use / Indications for Use
IMMULITE® OM-MA is a clinical use device intended for use with the IMMULITE Automated Immunoassay Analyzer for the quantitative measurement of CA125 antigen in human 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.
Product codes
LTK
Device Description
IMMULITE® OM-MA is a clinical device for use with the IMMULITE Automated Immuno-assay Analyzer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ovary
Indicated Patient Age Range
The summary mentions a study where samples were from individuals ranging from 17 to 80 years of age, and ovarian cancer patients ranging from 26 to 81 years of age. It also states, "more than 48% of ovarian cancer can be found in women 65 years of age and older, rather than in younger women. The incidence increases with age, reaching a peak of 54 in every 100,000 women in the age group 75 to 79 years."
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
The clinical performance of the IMMULITE OM-MA procedure was evaluated in two clinical sites in the United States. Thirty serially monitored ovarian cancer patients each provided between 4 and 41 serial specimens over the course of their disease, during which the patients manifested several clinical incidents (regression, stability and progression). IMMULITE OM-MA measurements of CA 125 were examined and compared with the clinical status.
The IMMULITE OM-MA procedure was also compared to Centocor CA 125 II, a commercially available RIA, on 165 samples from 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), with CA 125 concentrations ranging from 1.4 to 411 U/mL, as measured by the IMMULITE OM-MA assay.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Method Comparison:
The clinical performance of the IMMULITE OM-MA procedure was evaluated in two clinical sites in the United States.
Sample size: 30 serially monitored ovarian cancer patients, providing between 4 and 41 serial specimens each.
Key results: A table showing the association between clinical status (Regression, Stable, Progression) and IMMULITE OM-MA Test Results (CA 125 Increasing, CA 125 Stable, CA 125 Decreasing).
Chi-square = 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.
0
SEP 1 8 1998
510 (k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in Into sammery of - requirements of SMDA 1990 and 21 CFR Part 807.92.
Name: Address:
Telephone Number:
Contact Person;
Date of Preparation:
Catalog Number:
Device Name Trade: Common:
Classification:
Manufacturer:
Sole U. S. Importer:
Establishment Registration #:
Substantially Equivalent: Predicate Device:
Diagnostic Products Corporation 5700 West 96th Street Los Angeles, California 90045
(213) 776-0180
Edward M. Levine, Ph.D.
September 15, 1998
LKOPZ, LKOP1, LKOP5 (50, 100, 500 tests)
IMMULITE® OM-MA Reagent system for the Determination of CA125 antigen in serum.
LTK, Class II device
Euro/DPC Limited Glyn Rhonwy Llanberis, Gwynedd LL55 4EL United Kingdom (Manufactured under a Quality System-ISO 9002/EN29002/BS 5750)
Diagnostic Products Corporation (DPC) 5700 West 96th Street Los Angeles, CA 90045-5597
Euro/DPC - Not applicable DPC Registration number is 2017183
Centocor® CA 125 II™ RIA (P85009/S001- S007) @ 015
1
Description of Device:
IMMULITE® OM-MA is a clinical device for use with the IMMULITE Automated Immuno-assay Analyzer.
DPC LA ADMIN.
Intended Use of the Device:
IMMULITE® OM-MA is a clinical use device intended for use with the IMMULITE Automated Immunoassay Analyzer for the quantitative measurement of CA125 antigen in human 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.
Summary and Explanation of the Test:
The CA125 determinant was originally identified by a monoclonal antibody, selected for reactivity with a cell line from a patient with serous papillary cystadenocarcinoma of the ovary. This antibody was found to react with cell lines derived from epithelial ovarian carcinomas but not with nonmalignant tissues including normal adult and fetal ovary.
Although the precise nature of the CA125 determinant remains unclear, there is agreement that the molecule is a high molecular weight (1000 kDa) glycoprotein with a smaller quantity of carbohydrate than mucins. There is some evidence that more than one form of the CAI25 molecule exists.
Epithelial neoplasms of the ovary originate from the single layer of cells covering the ovary. These epithelial cells have a high proliferative capacity, repairing the ovarian surface after ovulation. Suppression of ovulation by oral contraceptives, pregnancy and lactation may therefore reduce the risk of ovarian cancer. Ovarian malignancy has been associated with a variety of peptide growth factors, oncogenes and turnor suppressor genes. According to a recent study comprising approximately 10% of the US population, more than 48% of ovarian cancer can be found in women 65 years of age and older, rather than in younger women. The incidence increases with age, reaching a peak of 54 in every 100,000 women in the age group 75 to 79 years.
Measurement of CA125 before and after cytoreductive surgery for ovarian cancer has been shown to predict the likelihood of a patient being left with residual disease.
2
IMMULITE OM-MA uses a murine monoclonal antibody for the capture and a rabbit polyclonal antibody for detection of the CA 125 antigen. The monoclonal antibody was established by immunization with human mucin prepared from a pool of patients with epithelial ovarian cancer. The monoclonal antibody, which forms the basis of specificity for the kit, recognizes a repetitive protein determinant expressed in the protein core of the CA 125 antigen. This antibody has specificity for an epitope that overlaps with, or is very near to, that bound by the M11 monoclonal antibody. The M11 monoclonal is incorporated in many commercially available CA 125 immunoassays. The polyclonal antibody is affinity purfiled against CA 125 antigen, resulting in a reagent reacting with multiple epitopes on this antigen.
Performance Equivalence - Technology Comparison:
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.
The Centocor® CA 125 II RIA is a one-step "sandwich" radioimmunoassay. Polystyrene beads coated with the M11 capture antibody reactive with molecules containing OC 125 reactive determinants are incubated with the patient sample, standards or control, and tracer. The tracer, composed of 1551 labeled (mouse monoclonal) OC 125 quantifies the number of OC 125 reactive determinants and is distinct from the solid phase antibody. During this incubation, molecules which contain OC 125 reactive determinants form "sandwich" complexes with the monoclonal antibodies. Unbound materials present in the patient sample are removed by aspiration of the fluid and washing of the beads. The bound radioactivity is determined by counting the beads in a gamma counter. The bound radioactivity is proportional to the concentration of the OC 125 reactive determinant (antigen) in the patient sample within the working range of the assay. A standard curve is obtained by plotting the U/mL of CA 125 II Standards vs. bound radioactivity (CPMs). The CA 125 assay values for patient samples and controls, run concurrently with the standards, can be determined from the standard curve.
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3
Performance Equivalence - Method Comparison:
The clinical performance of the IMMULITE OM-MA procedure was evaluated in two clinical sites in the United States. Thirty serially monitored ovarian cancer patients each provided between 4 and 41 serial specimens over the course of their disease, during which the patients manifested several clinical incidents (regression, stability and progression). IMMULITE OM-MA measurements of CA 125 were examined and compared with the clinical status. The association between clinical status and the IMMULITE OM-MA CA-125 measurements is presented below.
| IMMULITE OM-MA Test Results | ||||
|---|---|---|---|---|
| Clinical Status | CA 125 | |||
| Increasing | CA 125 | |||
| Stable | CA 125 | |||
| Decreasing | Total | |||
| Regression | 0 | 2 | 15 | 17 |
| Stable | 11 | 21 | 4 | 36 |
| Progression | 12 | 6 | 0 | 18 |
| Total | 23 | 29 | 19 | 71 |
x== 50.7, df= 4, p