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510(k) Data Aggregation
(30 days)
CYTOSCAN(R) DX
CytoScan® Dx Assay is a qualitative assay intended for the postnatal detection of copy number variations (CNV) in genomic DNA obtained from peripheral whole blood in patients referred for chromosomal testing based on clinical presentation. CytoScan® Dx Assay is intended for the detection of CNVs associated with developmental delay, intellectual disability, congenital anomalies, or dysmorphic features. Assay results are intended to be used in conjunction with other clinical and diagnostic findings, consistent with professional standards of practice, including confirmation by alternative methods, parental evaluation, clinical genetic evaluation, and counseling, as appropriate. Interpretation of assay results is intended to be performed only by healthcare professionals, board certified in clinical cytogenetics or molecular genetics. The assay is intended to be used on the GeneChip® System 3000Dx and analyzed by Chromosome Analysis Suite Dx Software (ChAS Dx Software).
This device is not intended to be used for standalone diagnostic purposes, preimplantation or prenatal testing or screening, population screening, or for the detection of, or screening for, acquired or somatic genetic aberrations.
The CytoScan Dx consists of five reagent modules, a microarray kit, and analysis software. The five reagent modules are:
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- MOD R L A, CytoScan® Dx Pre-PCR contains buffers, nucleotides, enzyme, and primers and adaptors for amplification;
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- MOD T E W, CytoScan® Dx Pre-PCR contains buffer and nuclease free water for amplification;
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- MOD F L H, CytoScan® Dx Post-PCR contains buffers, nucleotides, and enzyme for fragmentation, labeling and hybridization;
- MOD S AH W PB, CytoScan® Dx Post-PCR contains buffers, nuclease free water, and purification beads for stain and array hold;
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- MOD E PW CytoScan® Dx Post-PCR contains buffer for elution and purification wash.
The CytoScan® Dx Post-PCR CytoScan® Dx Array kit, 6-pack is designed for 6 runs. The microarray contains approximately 2,696,550 functional markers, each of which is approximately 25 bases long.
ChAS Dx Analysis Software and Browser v1.0.0 analyzes CEL file microarray data.
The Affymetrix® CytoScan® Dx Assay is a qualitative assay intended for the postnatal detection of copy number variations (CNV) in genomic DNA from peripheral whole blood in patients referred for chromosomal testing based on clinical presentation. It detects CNVs associated with developmental delay, intellectual disability, congenital anomalies, or dysmorphic features.
Here's an analysis of the acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly listed in a single table within the provided text. However, they can be inferred from the "Required Mitigations" and the detailed performance study descriptions. The reported device performance is extracted from the study results.
Inferred Acceptance Criteria and Reported Device Performance for Affymetrix® CytoScan® Dx Assay
| Acceptance Criteria Category | Specific Performance Metric / Criterion | Reported Device Performance |
|---|---|---|
| Reproducibility (Site-to-Site) | Overall pairwise replicate agreement for CNVs (>=50% overlap, same state) | 79.4% for all CNVs (range 65.7-100%). |
| 75.5% for gains, 82.4% for losses (kb-based, 50% overlap). | ||
| 82.2% for all CNVs (marker-based, 50% overlap). | ||
| Overall pairwise replicate agreement for CNVs (>=80% overlap, same state) | 71.9% for all CNVs (kb-based, 80% overlap). | |
| Reproducibility of Copy Number (0, 1, 2, 3, 4+) | 82.7% agreement across all CNVs (regardless of location/size/marker number). | |
| Median % Absolute Endpoint Deviation (Overall, excluding HR) | 0.03 (mean, 0.00 min, 0.00 median, 0.77 max) for both markers and kb. | |
| Reproducibility of LOH calls (3-4 Mb) | 91.9% call rate; 92.4% pairwise replicate agreement (50% overlap); 86.0% (80% overlap). | |
| Detection Limit (DNA Input) | Reliable detection of CNV markers | 10 ng genomic DNA is a conservative lower limit; assay functions appropriately with input up to 500 ng. |
| Detection Limit (Mosaicism) | Reliable detection of mosaic segments | Reliably detects mosaicism greater than 20% (mean AUC=0.96 at 15% mosaicism, but still states >20% being reliable). |
| Analytical Specificity (Interfering Substances) | Array QC and assay performance to meet acceptance criteria in presence of bilirubin, triglycerides, hemoglobin. | All results met sponsor's acceptance criteria; no interference observed. |
| Analytical Specificity (Carryover) | No significant difference in copy number state determination or array QC metrics between first and fifth runs in sequential processing. | No significant difference in copy number state (Wilcoxon signed rank statistic (S) = 0.5, p-value = 1.00) or array QC metrics (p > 0.05). |
| Analytical Specificity (Cross-Contamination) | SNPQC ≥ 12 at approximately 20% contamination. | SNPQC values ≥12 indicate absence of substantial cross-contamination. |
| Accuracy (Overall CNVs vs. Sequencing) | Agreement between CytoScan Dx and sequencing (>50% overlap or size, same state) | 78.8% agreement (all CNVs). |
| Accuracy (Overall CNVs vs. Composite Method) | Agreement between CytoScan Dx and composite method (>50% overlap or size, same state) | 88.7% agreement (all CNVs, excluding hypervariable regions). |
| Accuracy (LOH Regions vs. Sequencing) | PPA for LOH regions >=3 MB | 100.0% (159/159) for LOH regions 3 MB and greater. |
| Accuracy (Syndromic LOH vs. Published) | Detection of known LOH regions (e.g., from Gibson et al.) | Identified all 20 (100.0%) specifically described regions (>=5 MB) by Gibson et al. |
| Endpoint Accuracy | Endpoint agreement ( |
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