Search Results
Found 1 results
510(k) Data Aggregation
(265 days)
The Dry Tri T-STAT (CD3/CD4/CD8) reagent, intended for in vitro diagnostic use, is a three color immunofluorescence stain for the labeling, identification, and enumeration of helper/inducer (CD3+CD4+) and cytotoxic/suppressor (CD3+CD8+) T lymphocytes combined with a precise number of fluorescent counting beads to provide absolute CD4+ and CD8+ T-Cell counts on a single platform. This reagent is intended to be used for flow cytometric analysis of erythrocyte-lysed human whole blood. The Tri T-STAT Reagent can be used to monitor forms of immunodeficiency.
The Dry Tri T-STAT (CD3/CD4/CD8) reagent contains Atto488 - labeled CD4 monoclonal antibody (clone RPA-T4); phycoerythrin(PE) - labeled CD8 monoclonal antibody (clone LT8); and PE = Dyomics649 - labeled CD3 monoclonal antibody (clone UCHT1) formulated with fluorescent counting beads and stabilizers. The conjugated antibodies and beads are dispensed into flow cytometer compatible plastic tubes and dried. The material in each tube is used to process a single sample. The Dry Tri T-STAT (CD3/CD4/CD8) reagent, three color immunofluorescence stain, labels, identifies, and enumerates helper/inducer (CD3+CD4+) and cytotoxic/suppressor (CD3+CD8+) T lymphocytes. Combined with a precise number of fluorescent counting beads, in each tube, the reagent provides absolute CD4+ and CD8+ T-Cell counts on a single platform.
The provided text describes the performance characteristics of the Dry Tri T-STAT (CD3/CD4/CD8) reagent, a device for enumerating T lymphocytes.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Characteristic | Reported Device Performance |
|---|---|
| Precision/Reproducibility | Acceptable. Average %CV better than 10% for high, medium, and low count samples (10 replicates within run). |
| Linearity (CD4+ T-cells) | Acceptable. Correlation coefficient > 0.99 over reportable range (65-1500 cells/ul). |
| Linearity (CD8+ T-cells) | Acceptable. Correlation coefficient > 0.99 over reportable range (50-1500 cells/ul). |
| Sample Stability (24 hours post-draw) | Acceptable for absolute CD4+ and CD8+ T-cell concentrations. |
| Sample Stability (7 days, processed at phlebotomy) | Acceptable for absolute CD4+ and CD8+ T-cell concentrations. |
| Cross-reactivity | Monoclonal antibodies' specificities (established at International Workshops on Human Leukocyte Differentiation Antigens) were maintained after conjugation. |
| Correlation to Predicate Devices (CD4+ T-cell counts) | R² = 0.99, 0.93, 0.91, & 0.99 when compared at four different sites. |
| Correlation to Predicate Devices (CD8+ T-cell counts) | R² = 0.96, 0.91, & 0.96 when compared at four different sites. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: 291 samples were used for the correlation study against predicate devices.
- Data Provenance: The correlation study was conducted at "four different sites." The country of origin is not explicitly stated, but the submission is to the US FDA, implying relevance to a US context or similar regulatory standards. The study appears to be retrospective in the sense that the predicate devices are already established, and these samples were analyzed using both the new device and predicate devices. However, the exact nature (e.g., archived samples vs. newly collected for the study) is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. The ground truth for the correlation study appears to be the results obtained from the predicate devices, not an expert-established ground truth.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. The study design directly compares the new device's output to that of predicate devices; there is no indication of an independent adjudication process for discrepancies.
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
This information is not applicable and therefore not provided. The device is a diagnostic reagent for flow cytometric analysis, not an AI-assisted diagnostic tool that involves human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Yes, the performance characteristics described (precision, linearity, sample stability, cross-reactivity, and correlation to predicate devices) represent the standalone performance of the Dry Tri T-STAT reagent. There is no mention of human input or "human-in-the-loop" influencing its measurement outputs once samples are processed according to the "no wash" protocol.
7. The Type of Ground Truth Used
For the correlation study, the "ground truth" was established by comparison to predicate devices. For other performance characteristics (precision, linearity, stability), the ground truth is implicitly based on established analytical standards and measurements within an accredited lab setting, rather than expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
This information is not provided and is not applicable as this device is a reagent for laboratory testing and not an AI/machine learning algorithm requiring a "training set" in the computational sense.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is not applicable as the device is a reagent and does not involve a training set.
Ask a specific question about this device
Page 1 of 1