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510(k) Data Aggregation
(765 days)
The Eonis™ SCID-SMA kit is intended for the semi-quantitative determination of TREC (T-cell receptor excision circle) as an aid in screening newborns for Severe Combined Immunodeficiency (SCID) and for the semi-quantitative determination of KREC (Kappa-deleting recombination excision circle) as an aid in screening newborns for X-linked agammaglobulinemia (XLA). The test is intended for DNA from blood specimens dried on a filter paper and for use on the QuantStudio™ Dx Real-Time PCR instrument.
This test is not intended for screening of SCID-like Syndromes, such as DiGeorge Syndrome, or Omenn Syndrome. lt is also not intended to screen for less acute SCID syndromes such as leaky-SCID or variant SCID. The test is not indicated for screening B-cell deficiency disorders other than XLA, such as atypical XLA, or for screening of XLA carriers.
This test is not intended for use as a diagnostic test and a positive screening result should be followed by confirmatory testing.
The Eonis SCID-SMA kit is a multiplex real-time PCR-based assay. It uses target sequence-specific primers and TaqMan™ probes to amplify and detect three targets: TREC, and RPP30, in the DNA extracted from newborn dried blood spot (DBS) using Eonis DNA Extraction kit in a single PCR reaction.
Each Eonis SCID-SMA kit contains reagents for up to 384 reactions (for 3241-001U) or 1152 reactions (for 3242-001U) including kit controls.
The document describes the Eonis SCID-SMA kit, a real-time PCR-based assay for newborn screening of Severe Combined Immunodeficiency (SCID) and X-linked agammaglobulinemia (XLA). The study provided demonstrates the device's analytical and screening performance to support its substantial equivalency to a predicate device.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" as a separate table. However, it presents Sensitivity and Specificity for both TREC and KREC analytes, which serve as key performance metrics. These values are compared to the predicate device.
Reported Device Performance of Eonis SCID-SMA Kit:
| Analyte | Metric | Percent | Confidence Limits |
|---|---|---|---|
| TREC | Sensitivity | 100 % | 80.5 % - NA |
| False-negative rate | 0 % | NA - 19.5 % | |
| Specificity | 99.7 % | 99.4 % - 99.9 % | |
| False-positive rate | 0.3 % | 0.1 % - 0.6 % | |
| KREC | Sensitivity | 100 % | 54.1 % - NA |
| False-negative rate | 0 % | NA - 45.9 % | |
| Specificity | 99.7 % | 99.4 % - 99.9 % | |
| False-positive rate | 0.3 % | 0.1 % - 0.6 % |
Comparison to Predicate Device (PerkinElmer EnLite Neonatal TREC Kit) for TREC:
| Analyte | Metric | Percent | Confidence Limits |
|---|---|---|---|
| TREC | Sensitivity | 100 % | 79.4 % - NA |
| False-negative rate | 0 % | NA - 20.6 % | |
| Specificity | 99.7 % | 99.4 % - 99.8 % | |
| False-positive rate | 0.3 % | 0.2 % - 0.6 % |
The reported performance clearly aims to meet or exceed the performance of the predicate device, demonstrating 100% sensitivity and high specificity for both analytes.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Screening Performance Study (Test Set):
- Total DBS specimens: 3090
- Confirmed SCID positive: 17
- Confirmed XLA positive: 6
- Normal newborn screening specimens: 3018 (retrospective archived)
- Data Provenance: Retrospective archived dried blood spot specimens.
- Country of Origin: US and Denmark.
- Study conducted in Denmark.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not explicitly stated as a specific number. The document mentions "clinical experts" were used.
- Qualifications of Experts: The document states "clinical experts" retrospectively reviewed the clinical status of routine subjects to confirm they were from unaffected individuals. Further specific qualifications (e.g., specific medical specialty, years of experience) are not provided in this document.
4. Adjudication Method for the Test Set
- Adjudication Method: The document describes a retesting protocol for initial "screen positive" results.
- "The specimens having TREC and KREC levels below the cut-off values in the initial round of testing were re-tested in duplicate."
- "The final results (presumptive positive, invalid result) were classified after the second round of testing."
- This implies a form of internal re-adjudication based on duplicate retesting for samples near the cut-off. There is no mention of external expert adjudication for discordant results or a specific "X+Y" type of adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an in-vitro diagnostic (IVD) kit for semi-quantitative determination of biomarkers, not an AI assisting human readers of medical images. Therefore, the concept of human readers improving with AI assistance is not applicable to this type of device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Yes, the entire performance data regarding sensitivity, specificity, reproducibility, precision, limit of detection, and linearity are based on the standalone performance of the Eonis SCID-SMA kit (the algorithm of the kit combined with the instrument) on dried blood spot samples. This device operates as an automated assay, therefore, its performance is inherently "standalone" in terms of its analytic and clinical validity.
7. The Type of Ground Truth Used
- Ground Truth Type:
- Confirmatory testing: For SCID and XLA positive cases, "Confirmatory test results were used as the comparator." This implies clinical diagnosis or gold standard laboratory tests.
- Clinical expert retrospective review: For normal newborn screening specimens, "The clinical status of the routine subjects was determined through a retrospective review by clinical experts to confirm the routine subject cohort samples were from unaffected individuals." This indicates clinical outcomes or medical records adjudicated by experts.
8. The Sample Size for the Training Set
- Training Set Sample Size: The document does not explicitly state the sample size of a separate "training set" for the assay. The study described is a clinical validation (test set). For assay development (which would include "training" for establishing parameters like cut-offs), the document mentions:
- Cut-off values were established using "an independent dataset." The size of this independent dataset is not specified.
- Reproducibility and precision studies used panels of dried blood spots at different TREC/KREC levels, but these are for analytical validation rather than establishing classification criteria.
9. How the Ground Truth for the Training Set Was Established
- Training Set Ground Truth Establishment: As no specific "training set" is detailed, the method for establishing ground truth for any data used during the assay's development or cut-off determination (the "independent dataset" mentioned for cut-off study) is not explicitly described. However, it's reasonable to infer that similar methods to the test set ground truth (confirmatory testing for affected individuals and clinical review for unaffected individuals) would have been applied during the development phase.
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