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510(k) Data Aggregation
(174 days)
The Diamedix Is-CMV IgG an Enzyme Immunoassay (EIA) for the qualitative and semi-quantitative determination of IgG antibodies in human serum by EIA to aid in the assessment of the patient's immunological response to CMV and to determine the immune status of individuals, including females of child-bearing age. The evaluation of acute and convales of child-bearing age. The evaluation of aculture infection, reactivated infection, or resident of primary infection, reactiveled infection, or reinfection with CMV. These reagents can be used either manually or in conjunction with CMV. These reage Automated EIA Processor Automated EIA Processor.
The Is-CMV IgG Test System is an enzyme-linked immunosorbent assay (ELISA) for the detection and semi-quantitation of IgG to CMV antigen in human serum
Acceptance Criteria and Device Performance for the Diamedix Is-CMV IgG Test System
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state pre-defined acceptance criteria (e.g., "the device must achieve a sensitivity of at least X%"). Instead, it presents performance characteristics from comparison studies and other tests. The "reported device performance" below highlights key metrics from these studies.
| Performance Metric | Acceptance Criteria (Not explicitly stated, but implied by regulatory submission) | Reported Device Performance (Range across studies/sites) |
|---|---|---|
| Relative Sensitivity | High agreement with predicate device | 96.6% - 100.0% |
| Relative Specificity | High agreement with predicate device | 87.8% - 100.0% |
| Overall Agreement | High agreement with predicate device | 97.0% - 99.0% |
| Correlation: Manual vs. MAGO Plus | Strong positive correlation (e.g., R-value close to 1) | R-value: 0.9568 |
| CDC Serum Panel Agreement | High agreement with CDC results (masked characterized panel) | 99% total agreement; 100% agreement for positive and negative samples (both manual and automated) |
| Linearity | Demonstrated linearity throughout reportable range | Representative graphs show linearity over reportable range (R-values > 0.99) |
| Cross-Reactivity | No significant cross-reactivity with common interfering viruses | No cross-reactivity detected with various IgG antibodies (VZV, HSV 1/2, Toxoplasma, Rubella, EBV, Measles) |
| Precision (Interassay CV%) | Acceptable variability (generally <20% for quantitative assays, but depends on assay type and concentration) | Varies by serum sample and site, generally within acceptable ranges (e.g., typically <20%, some low-concentration samples higher) |
Note: The document explicitly states: "NOTE: Please be advised that 'relative' refers to the comparison of the assay's results to that of a similar assay. There was not an attempt to correlate the assay's results with disease presence or absence. No judgment can be made on the comparison assay's accuracy to predict disease." This clarifies that the primary acceptance criteria for this 510(k) submission revolve around substantial equivalence to a predicate device, rather than direct clinical diagnostic accuracy.
2. Sample Sizes Used for the Test Set and Data Provenance
The primary performance evaluation involves comparison testing with marketed tests at three sites.
- Total Samples Tested: 587 sera
- Site #1 (Miami, FL): 200 samples (26% fresh, 74% frozen), obtained from the S. Florida area.
- Site #2 (Salt Lake City, Utah): 178 samples (all fresh), obtained from the Mid-West area.
- Site #3 (Diamedix Corp., Miami, FL): 209 samples (all frozen) for manual method, 206 samples (three being QNS) for MAGO Plus method. Samples obtained from S. Florida blood donors.
- CDC Serum Panel: Unspecified number of samples, with a composition of 66% positive and 34% negative samples for CMV.
- Cross-Reactivity Studies: 47 sera negative for CMV IgG but positive for one or more other viruses.
- Expected Values Study: 100 healthy South Florida donors (52 female, 48 male).
Data Provenance: The data comes from retrospective (frozen samples) and prospective (fresh samples) collections in the USA (S. Florida and "Mid-West area").
3. Number of Experts Used to Establish Ground Truth for the Test Set and Expertise
The "ground truth" for the comparison testing was established by the predicate device (another marketed CMV IgG EIA test) and, in cases of discordance, a "referee EIA." The document does not specify the number or qualifications of experts involved in running or interpreting the predicate and referee ELISAs. It is assumed that laboratory professionals with appropriate training and experience in serological testing for CMV would perform these assays as part of standard laboratory practice.
For the CDC Serum Panel, the samples were from a "masked characterized serum panel," implying that the CDC had previously established the CMV IgG status of these samples, likely through a consensus of reference methods or expert evaluation. No specific number or qualifications of experts are provided.
4. Adjudication Method for the Test Set
For the comparison testing:
- The results of the Is-CMV IgG test were compared against "their currently used testing method" (predicate EIA) at Sites #1 and #2, and "another marketed EIA method" at Site #3.
- Discordant results (where the Is-CMV IgG disagreed with the predicate device) were further tested by a "referee EIA." The results of the referee EIA were used to determine the final classification of these discordant samples. The specific decision rule for the referee EIA (e.g., if it always overrides, or needs 2 out of 3 agreement) is not explicitly detailed, but its role implies it served as an adjudicator for discrepancies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This device is an in vitro diagnostic (IVD) assay, and its performance is evaluated based on its analytical accuracy (sensitivity, specificity, agreement) against reference methods or predicate devices, not on how human readers interact with or interpret its results in a diagnostic setting to improve performance. The "human readers" in this context are laboratory technicians performing the assay, not clinicians interpreting imaging or other complex data assisted by AI.
6. Standalone Performance Study (Algorithm Only)
Yes, a standalone performance study was conducted. The entire evaluation (comparison testing, correlation of manual and automated methods, CDC panel testing, linearity, cross-reactivity, and precision) represents the performance of the Diamedix Is-CMV IgG Test System as a standalone diagnostic assay (both manually and using the MAGO Plus Automated EIA Processor). Its performance is reported independently rather than as an assist to human interpretation in a cognitive task.
7. Type of Ground Truth Used
The ground truth used was a combination of:
- Predicate Device/Reference EIA Results: For the primary comparison studies, the results of other marketed CMV IgG EIA tests, and a "referee EIA" for discordant samples, served as the ground truth. This is a form of expert consensus/reference method truth based on established methodologies.
- Masked Characterized Serum Panel: For the CDC serum panel data, the ground truth was based on the CDC's prior characterization of the samples. This represents an established reference standard.
- No pathology or outcomes data was used as ground truth for this submission, as explicitly stated: "There was not an attempt to correlate the assay's results with disease presence or absence."
8. Sample Size for the Training Set
The document does not provide information about a separate "training set" in the context of machine learning. This device is a traditional immunoassay, not an AI/ML-based device that typically undergoes a distinct training phase with labeled data. The reported studies evaluate the finished product.
9. How the Ground Truth for the Training Set Was Established
As noted above, there is no mention of a "training set" as understood in AI/ML development for this immunoassay. The studies described are performance validation studies for the device, not a development phase involving training data.
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