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510(k) Data Aggregation
(209 days)
Architect CMV IgG
The ARCHITECT CMV IgG assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of IgG antibodies to cytomegalovirus in human serum, serum separator, and plasma tubes (lithium heparin, lithium heparin separator, and tripotassium EDTA) on the ARCHITECT i System.
The ARCHITECT CMV IgG assay is to be used as an aid in the diagnosis of infection with cytomegalovirus and as an aid in the determination of serological status to cytomegalovirus in individuals including women of child-bearing age.
The ARCHITECT CMV IgG assay has not been cleared for use in screening blood, plasma, or tissue donors.
The ARCHITECT CMV IgG assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of IgG antibodies to cytomegalovirus. The reagent kit contains microparticles coated with CMV virus lysate, murine anti-human IgG acridinium-labeled conjugate, and assay diluent. The assay is performed on the ARCHITECT i System. The presence or absence of anti-CMV IgG is determined by comparing the chemiluminescent relative light unit (RLU) in the reaction to a cutoff RLU from an active calibration.
Here's an analysis of the acceptance criteria and study information for the ARCHITECT CMV IgG device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as numerical targets in the document. However, based on the non-clinical and clinical performance summaries, we can infer performance goals for the device's accuracy and precision. The "Predicate Device" (ADVIA Centaur CMV IgG Assay, K181213) serves as a benchmark for substantial equivalence.
| Performance Metric | Acceptance Criteria (Inferred from Study Design & Predicate Equivalence) | Reported Device Performance (ARCHITECT CMV IgG) |
|---|---|---|
| Within-Laboratory Precision (Repeatability) | Low variability; %CV values typically +0.6 AU/mL) noted for Triglycerides at 2475 mg/dL on 4.0 AU/mL sample. | |
| Drugs/Other Substances: No significant interference observed for Acetaminophen, Ascorbic Acid, Beta Carotene, Biotin, Cidofovir, Diphenhydramine, Folic Acid, Foscarnet, Gangciclovir, Ibuprofen, Valganciclovir. | ||
| Analytical Specificity (Other Conditions) | Low rate of false positives/reactives with specimens from individuals with unrelated medical conditions. | 1 reactive result out of 187 specimens tested across various medical conditions (Toxoplasmosis (IgG) specimen was reactive). 1 equivocal parvovirus B19 (IgG) specimen. |
| CDC Panel Agreement (Positive) | High positive percent agreement, ideally >90% | 100% (91.59%, 100%) |
| CDC Panel Agreement (Negative) | High negative percent agreement, ideally >90% | 92.11% (78.62%, 98.34%) |
| CDC Panel Agreement (Overall) | High overall percent agreement, ideally >90% | 96.25% (89.43%, 99.22%) |
| Clinical Percent Agreement (Positive) - Routine Order | High positive percent agreement with comparator, ideally >90% | 97.7% (96.1%, 98.7%) |
| Clinical Percent Agreement (Negative) - Routine Order | High negative percent agreement with comparator, ideally >90% | 99.2% (97.3%, 99.8%) |
| Clinical Percent Agreement (Positive) - Pregnant Females | High positive percent agreement with comparator, ideally >90% | 99.0% (94.5%, 99.8%) |
| Clinical Percent Agreement (Negative) - Pregnant Females | High negative percent agreement with comparator, ideally >90% | 100.0% (96.4%, 100.0%) |
2. Sample Size Used for the Test Set and Data Provenance
- Within-Laboratory Precision (20-Day): 117-120 replicates per panel/control across 3 reagent lots/calibrator lot combinations.
- Analytical Specificity (Interference): Not explicitly stated, but each substance was tested at 3 analyte levels.
- Analytical Specificity (Other Conditions): 187 specimens.
- CDC Panel Agreement: 80 samples (either CMV IgG negative or CMV IgG positive). Data provenance is the Centers for Disease Control and Prevention (CDC). The document doesn't specify if this was retrospective or prospective, but the description "masked, characterized serum panel" suggests it was a curated, retrospective panel.
- Clinical Percent Agreement:
- Routine Order: 591 specimens collected in the US and 198 specimens collected outside of the US.
- Pregnant Females: 200 specimens collected in the US.
- Further Evaluation: 4 specimens (3 routine order, 1 pregnant female) with equivocal/grayzone results by the comparator assay.
- Data provenance for the clinical study is multi-site (Indianapolis Indiana, Lewisville Texas, and Palo Alto California) for the US samples, and unspecified international locations for the "outside of the US" routine order specimens. This was a clinical study (method comparison), suggesting prospective collection relative to the comparison against the investigational assay.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no information provided about experts being used to establish a ground truth for the test set in the conventional sense (e.g., for image interpretation).
- For the CDC Panel Agreement, the CDC provided "their result interpretation for each sample," implying the CDC's own characterization (likely by reference methods/consensus) served as the ground truth. No specific number or qualifications of experts are given.
- For the Clinical Percent Agreement, the ground truth was established by a "current, FDA-cleared, commercially available anti-CMV IgG assay" (the comparator assay), essentially establishing a reference standard from an already approved diagnostic device. For 4 equivocal/grayzone samples, "consensus testing" with "2 additional current, FDA-cleared, commercially available anti-CMV IgG assays" was used. The document does not mention human experts establishing ground truth for these studies.
4. Adjudication Method for the Test Set
- CDC Panel Agreement: The results were compared directly to CDC's result interpretation. No explicit adjudication method is described beyond this direct comparison.
- Clinical Percent Agreement: The primary comparison was against a single comparator assay. For specific equivocal/grayzone cases (4 specimens), a form of adjudication was used where the result was "negative by consensus testing" or "negative based on the consensus result from the comparator assay and 2 additional current, FDA-cleared, commercially available anti-CMV IgG assays." This implies a form of multi-comparator consensus for ambiguous cases, but not necessarily human expert adjudication in the traditional sense.
5. 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 MRMC comparative effectiveness study was done. This device is an automated in vitro diagnostic (IVD) assay (chemiluminescent microparticle immunoassay), not an AI-powered diagnostic imaging device or tool that assists human readers. Therefore, the concepts of human readers, AI assistance, and effect size in improving human reader performance are not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The device itself, the ARCHITECT CMV IgG assay on the ARCHITECT i System, is a standalone algorithm/device for qualitative detection. Its performance is evaluated entirely as an automated system without human interpretation in the loop influencing the direct output of IgG antibody detection. The "human-in-the-loop" would be the clinician interpreting the result provided by the device (e.g., Reactive, Nonreactive, Grayzone/Equivocal) in the context of a patient's overall clinical picture, but not in generating the result itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- CDC Panel Agreement: Ground truth was based on CDC's own "result interpretation" of their characterized serum panel. This likely represents a highly robust reference method or internal consensus.
- Clinical Percent Agreement: Ground truth was primarily established by a "current, FDA-cleared, commercially available anti-CMV IgG assay" (comparator assay). For a few ambiguous cases, consensus results from multiple FDA-cleared comparator assays were used. This is a form of reference method comparison.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning or AI. As this is a traditional immunoassay, it undergoes development and validation using various biological samples. However, no specific number is provided for samples used during the development or optimization phases that could be analogized to a training set. The clinical study samples described are specifically for performance evaluation (test set).
9. How the Ground Truth for the Training Set Was Established
As no explicit training set is defined (because it's not an AI/ML device), this question is not applicable. The assay's parameters (e.g., cutoff values) would have been established during product development using a large set of characterized samples and optimized for performance, but this is a different process than establishing ground truth for an AI training set.
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