(62 days)
OPUS® Anti CMV is a qualitative fluorogenic enzyme-linked immunosorbent assay (ELISA) used in the detection of total antibody to cytomegalovirus in human serum or heparin plasma to determine serological evidence of previous CMV infection. The OPUS Anti CMV assay is also intended for use to screen blood and/plasma donors to determine serological evidence of previous CMV infection. OPUS Anti CMV is intended for use with the OPUS analyzers.
OPUS Anti CMV is a qualitative fluorogenic enzyme-linked immunosorbent assay (ELISA), based on liquid phase binding of CMV antibodies to enzyme labeled recombinant CMV antigen. Each test module contains a solid phase recombinant protein A/G immobilized onto glass fiber. A recombinant CMV antigentalkaline phosphatase conjugate solution and a wash/substrate solution (4-methylumbellifery) phosphate) are sealed in separate well within the test module.
Here's a breakdown of the acceptance criteria and study information for the OPUS Anti CMV assay, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Precision | (Not explicitly stated, but typically a low CV%) | Intra-assay %CV's: 5.8-20% |
| Inter-assay %CV's: 8.9-21.4% | ||
| Interfering Substances | (No interference up to specified levels) | Levels of the listed substances (total protein, triglycerides, cholesterol, hemoglobin, immunoglobulins, bilirubin, Rheumatoid factor, ANA, Epstein-Barr, herpes simplex I/II, Herpes-Zoster, HBsAg, Elevated IgM, Anti-HIV Positive, Anti-HCV positive, Anti-HAV positive) do not appear to interfere up to the given concentrations/signal/cutoff values. |
| Accuracy by Correlation (Relative Sensitivity) | (Not explicitly stated, but typically high, e.g., >95%) | 96.6-97.7% |
| Accuracy by Correlation (Relative Specificity) | (Not explicitly stated, but typically high, e.g., >95%) | 100% |
| Expected Values (CMV Antibody Positive Frequency) | (Not an acceptance criterion for device performance, but a demographic characteristic) | Massachusetts: 27.4% |
| Florida: 14.4% | ||
| Illinois: 30.6% |
Note: The acceptance criteria for precision, relative sensitivity, and relative specificity are not explicitly stated as numerical targets in the provided text. They are inferred based on the reporting of these metrics and the context of a 510(k) submission, where such performance is expected to be robust.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated as a single number.
- For Accuracy by Correlation: "comparative studies using the OPUS Anti CMV assay and the Abbott CMV test in both preselected and blood donor populations"
- For Expected Values: "studies performed in blood and plasma donor centers"
- Data Provenance: The "Expected Values" section specifies Massachusetts, Florida, and Illinois as countries/regions of origin for the blood/plasma donor studies. The other studies (precision, interfering substances, and accuracy) do not specify geographic origin.
- Retrospective or Prospective: Not explicitly stated. The term "comparative studies" and "studies performed" don't provide this detail.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This document describes an in vitro diagnostic assay that detects total antibodies to cytomegalovirus. The "ground truth" for such assays is typically established by correlating results with a legally marketed predicate device (Abbott CMV Total AB EIA in this case), or by using established reference methods, not by expert human interpretation of images or other subjective data. No experts are mentioned in this context for establishing ground truth.
4. Adjudication Method for the Test Set
- Not Applicable. As mentioned above, the assessment is based on a direct comparison of assay results with a predicate device, not on human interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No such study was performed. This document describes an in vitro diagnostic device, not an imaging or diagnostic aid that involves human readers.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
- Yes, a standalone performance study was done. The entire document details the performance characteristics of the OPUS Anti CMV assay as a standalone device ("algorithm only" in the context of an IVD) without human intervention in the interpretation of the assay results themselves. The device generates a qualitative positive or negative result.
7. Type of Ground Truth Used
- The ground truth for the "Accuracy by Correlation" study appears to be the results obtained from the legally marketed predicate device, the Abbott CMV Total AB EIA. The study establishes "relative sensitivity" and "relative specificity" by comparing the OPUS Anti CMV assay's results to those of the Abbott CMV test.
8. Sample Size for the Training Set
- Not applicable / Not explicitly mentioned. For in vitro diagnostic assays like this, the concept of a "training set" as understood in machine learning (where an algorithm learns from labeled data) doesn't directly apply. The device's performance is characterized through verification and validation studies (precision, interference, accuracy) on clinical samples. The manufacturing process of the reagents and the calibration system are designed to consistently produce accurate results.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. See point 8. The device operates based on a defined chemical reaction and detection mechanism, not a learned algorithm requiring a "training set" with established ground truth in the traditional sense. The "training" here would be the development and optimization of the assay's reagents and protocols, likely using well-characterized samples, but this isn't detailed in the same way as a machine learning training set.
§ 866.3175 Cytomegalovirus serological reagents.
(a)
Identification. Cytomegalovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to cytomegalovirus in serum. The identification aids in the diagnosis of diseases caused by cytomegaloviruses (principally cytomegalic inclusion disease) and provides epidemiological information on these diseases. Cytomegalic inclusion disease is a generalized infection of infants and is caused by intrauterine or early postnatal infection with the virus. The disease may cause severe congenital abnormalities, such as microcephaly (abnormal smallness of the head), motor disability, and mental retardation. Cytomegalovirus infection has also been associated with acquired hemolytic anemia, acute and chronic hepatitis, and an infectious mononucleosis-like syndrome.(b)
Classification. Class II (performance standards).