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510(k) Data Aggregation
(244 days)
For in vitro diagnostic use to identify and enumerate absolute counts of T lymphocyte (CD3+), helper/inducer T lymphocyte (CD3+CD4+) and suppressor/cytotoxic T lymphocyte (CD3+CD8+) subsets in blood.
- For use with any flow cytometer equipped with a 488 nm last and capable of detection in . the ranges: 515-545 nm, 562-607 nm, and >650 nm
- For use with erythrocyte lysed whole blood .
- For in vitro diagnostic use .
- To identify and enumerate absolute counts of CD3+ and CD3+CD4+ and CD3+CD8+ . lymphocytes
- To characterize and monitor some forms of immunodeficiency, such as in HIV infected . individuals
- To characterize and monitor some forms of autoimmune diseases .
The BDIS TriTEST CD4 fluorescein isothiocyanate (FITC)/CD8 phycoerythrin (PE)/CD3 peridinin chlorophyll protein (PerCP) reagent is a three-color, direct immunofluorescence reagent. When used with TRUCOUNT Absolute Count Tubes it is used for identifying and enumerating absolute counts of I lymphocytes (CD3+), helper/inducer T lymphocytes (CD3+CD4+) and suppressor/cytotoxic I lymphocytes (CD3+CD8+) in erythrocyte-lysed whole blood (LWB). The Becton Dickinson TnTEST / TRUCOUNT system for immunophenotyping consists of a flow cytometer (either from BDIS or from another manufacturer), conjugated monoclonal reagent (Tril EST CD4 FITC/CD8 PE/CD3 PeCP) and TRUCOUNT Absolute Count Tubes.
The process to obtain T lymphocyte subset absolute counts includes: 1) obtaining a whole blood sample, 2) adding a precise volume of whole blood directly to the Absolute Count Tube, 3) cell-surface antigen staining with three-color monoclonal antibody reagents, 4) erythrocyte lysis, and 5) flow cytometric acquisition and analysis of list mode data. Analysis for absolute counts requires that the bead region be identified and the events in this region counted. The proportion of reagent positive events to bead events (P) is computed. The absolute count is I x (beads/pellet)/(volume of blood sample).
Here's an analysis of the provided text, extracting the requested information about the acceptance criteria and the study that proves the device meets them:
Acceptance Criteria and Device Performance Study for BDIS TriTEST™ Reagent with TRUCOUNT Absolute Count Tubes
This submission does not explicitly state specific numerical acceptance criteria for performance metrics. Instead, it relies on demonstrating substantial equivalence to a predicate device (FACSCount cleared under K933486). The "acceptance criteria" are therefore inferred as achieving performance equivalent to or demonstrably safe and effective as the predicate device for the specified indications for use.
The study aims to establish this equivalence, particularly for identifying and enumerating absolute counts of T lymphocytes (CD3+), helper/inducer T lymphocytes (CD3+CD4+), and suppressor/cytotoxic T lymphocytes (CD3+CD8+).
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Accuracy | Substantial equivalence to the predicate device (FACSCount) for CD3+, CD3+CD4+, and CD3+CD8+ absolute counts. | Accuracy data demonstrated the TriTEST/TRUCOUNT product's equivalence to FACSCount. "Results demonstrate that the products yield essentially equivalent performance characteristics." The TriTEST/TRUCOUNT system (for absolute counts) is substantially equivalent to the FACSCount system for CD3+, CD3+CD4+ and for CD3+CD8+. |
| Stability (Time-from-draw) | Blood specimens should be stained within a specified timeframe to maintain accurate absolute counts. | Blood specimens should be stained within 24 hours of draw. (Alternatively, stained within 48 hours of draw and analyzed within 6 hours). |
| Stability (Time-from-sample preparation) | Stained samples should be analyzed within a specified timeframe to maintain accurate absolute counts. | Analysis of stained samples should occur within 24 hours. (Alternatively, stained within 48 hours of draw and analyzed within 6 hours). |
| Within-specimen Reproducibility | Acceptable consistency in results when multiple aliquots from a single specimen are tested. | "Results demonstrated acceptable within-sample reproducibility." (Tested with 10 replicates from 1 high, 1 medium, and 1 low sample at BDIS, and 3 aliquots from each donor at 3 clinical sites). |
| Linearity | Linear response across a clinical range of lymphocyte and WBC concentrations. | "Results indicate a linear response over this range." (Determined using blood samples from 3 normal donors diluted to 5 concentrations, ranging from 16,700 to 200 lymphocytes/uL and from 31,000 to 2,500 WBC/uL). |
| Cross-reactivity | Monoclonal antibodies should maintain their specificity after conjugation and formulation. | "Conjugation and product formulation have not changed their specificity." (Cross-reactivity of clones is reported in literature). |
| Cross-platform Reproducibility | Acceptable comparability of results across different flow cytometer platforms. | Indicated a small (<20%) non-zero bias, but good correlation between results on a Becton Dickinson flow cytometer versus a Coulter. Users will be advised to validate performance characteristics as required under CLIA regulations. (Implies that while there's a bias, the correlation is good enough to allow for validation and use, with appropriate user validation). |
2. Sample Sizes Used for the Test Set and Data Provenance
- Accuracy Study:
- Sample Size: Not explicitly stated, but the study was conducted at multiple sites: Cleveland Clinic, Johns Hopkins Hospital, Institute of Tropical Medicine, University of North Carolina Hospital, and Becton Dickinson Immunocytometry Systems laboratories. The number of patients/samples isn't given.
- Data Provenance: Retrospective and/or Prospective (not specified, but clinical studies are generally prospective or involve fresh samples). Origin is USA (Cleveland Clinic, Johns Hopkins, UNC Hospital, BDIS San Jose) and potentially other countries (Institute of Tropical Medicine - country not specified).
- Stability Study (Time-from-draw/Stain): Not specified.
- Within-specimen Reproducibility:
- BDIS site: 3 samples (1 high, 1 medium, 1 low) with 10 replicates each (total 30 replicates).
- 3 clinical sites: Number of donors/samples not specified, but 3 aliquots from each donor were assessed.
- Linearity Study: Blood samples from 3 normal donors. Each donor's sample was diluted to 5 concentrations (15 total diluted samples tested).
- Cross-platform Reproducibility: Not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information about the number or qualifications of experts used to establish ground truth for the test set. Given the nature of a 510(k) for an in vitro diagnostic reagent, the "ground truth" would typically come from existing, FDA-cleared laboratory methods, often the predicate device itself, or established laboratory standards.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method for the test set. For IVD reagents, the comparison is usually quantitative between the new device and the predicate device, or against a gold standard method, rather than involving expert consensus for individual case adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically for image-based diagnostic systems where human readers interpret results, and the AI assists that interpretation. This device is a reagent/system for flow cytometry, which produces quantitative results, not images for human interpretation in the same way. Therefore, "human readers improve with AI vs. without AI assistance" is not applicable here.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This device is effectively a standalone algorithm/system in terms of its primary function. The flow cytometer with the reagent and TRUCOUNT tubes generates quantitative data (absolute counts) for cell populations. While a trained lab technician operates the flow cytometer and analyzes the data, the core "performance" of generating the counts is inherent to the reagent system itself. The studies described (accuracy, reproducibility, linearity) assess this "algorithm only" type of performance, comparing its output to that of the predicate device.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The ground truth used for these studies is primarily:
- Comparison to a Predicate Device: The main ground truth is the performance of the legally marketed FACSCount system (K933486). The studies aim to show the new device yields "essentially equivalent performance characteristics" and is "substantially equivalent" to this established device.
- Internal Validation/Standard Methods: For reproducibility, linearity, and stability, the ground truth is established through controlled laboratory experiments using known samples or dilutions, comparing results against expected values or consistency metrics.
- Literature: For cross-reactivity, it refers to existing literature on the specificity of the monoclonal antibody clones.
8. The Sample Size for the Training Set
The document does not mention a training set in the context of an algorithm or AI model development. This device is a reagent used in a flow cytometry system, not an AI model that requires a distinct training phase.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set for an AI model, this question is not applicable. The device's "training" in a broad sense would be the extensive research and development (R&D) and validation of the reagent formulation and system, not an AI-specific training phase with labeled data.
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