(43 days)
The BD TriTEST™ CD3FITC/CD4PE/CD45 PerCP reagent is a threecolor, direct immunofluorescence reagent for identifying and enumerating percentages of T lymphocytes (CD3+) and Thelper/inducer (CD3+CD4+) cells in erythrocyte-lysed whole blood (LWB). When used with TRUCOUNT™ Absolute Count Tubes, the product produces absolute counts in cells/uL.
For use with any flow cytometer equipped with a 488 nm laser and capable of detection in the ranges: 510-545 nm, 562-607 nm, and >650 nm.
For use in erythrocyte-lysed whole peripheral blood.
For use with or without isotype control.
To characterize and monitor some forms of autoimmune disease.
To characterize and monitor some forms of immunodeficiency disease, such as in HIV- infected individuals.
The BD TriTEST™ CD3FITC/CD4PE/CD45 PerCP reagent is a threecolor, direct immunofluorescence reagent for identifying and enumerating percentages of T lymphocytes (CD3+) and Thelper/inducer (CD3+CD4+) cells in erythrocyte-lysed whole blood (LWB). When used with TRUCOUNT™ Absolute Count Tubes, the product produces absolute counts in cells/μL. If used with Becton Dickinson flow cytometers, the product can be used with MultiSET™ software for analysis as an accessory, or customers may perform analysis using CELLQuest™, CELLQuest Pro™ or LYSYS™ II software. The reagent vials and counting bead vials are packaged separately. Each vial of this reagent yields 50 tests. Each package of counting bead tubes vields 50 tests.
The provided text is a 510(k) premarket notification for the BD™Tritest CD3/CD4/CD45 with Trucount Absolute Count Tubes. The submission pertains to a modification of an already cleared device, specifically to extend the sample stability claim. Consequently, the document focuses on demonstrating equivalency to the predicate device rather than presenting a full de novo study with detailed acceptance criteria and performance data for a new device.
Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert qualifications, and ground truth establishment is not explicitly detailed in the provided 510(k) summary. The summary refers to "Performance data from validation testing supports equivalency" but does not elaborate on the specifics of this data or the methods used to collect it.
However, based on the information provided, here's what can be inferred and stated:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as numerical targets for performance metrics like sensitivity, specificity, accuracy, or a specific statistical agreement. Instead, the modification aims to demonstrate equivalency to the predicate device for an extended sample stability period (from 48 to 72 hours for EDTA collected samples).
Therefore, the implicit acceptance criterion is that the device's performance for identifying and enumerating percentages and absolute counts of T lymphocytes and T-helper/inducer cells at 72 hours post-collection must be comparable or within acceptable limits of its performance at 48 hours and to the predicate device's performance for the original claim.
| Acceptance Criterion (Implicit) | Reported Device Performance (Inferred) |
|---|---|
| Equivalency of device performance (identifying T lymphocytes and T-helper/inducer cells) at 72 hours post-collection for EDTA blood to performance at 48 hours and to predicate device. | "Performance data from validation testing supports equivalency." (Specific metrics are not provided in the summary.) |
| Maintenance of intended use. | Intended use and indications for the modified device are the same as the original predicate device. |
2. Sample Size Used for the Test Set and the Data Provenance
The summary does not explicitly state the sample size used for the validation testing or the data provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The summary does not explicitly mention the use of experts to establish ground truth for the test set. For flow cytometry devices like this, the "ground truth" is typically established by the readings from the flow cytometer itself, often compared to an established reference method if a new principle is being introduced. For a modification, the comparison is usually against the predicate device's performance.
4. Adjudication Method for the Test Set
The summary does not explicitly describe any adjudication method for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improving with AI vs. Without AI Assistance
This device is an automated in vitro diagnostic device (flow cytometer reagent and counting beads) for cell enumeration, not an AI-powered diagnostic tool requiring human reader interpretation in the context of an MRMC study. Therefore, an MRMC study and AI assistance effect size are not applicable to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself, when used with a Becton Dickinson flow cytometer and software (MultiSET™, CELLQuest™, CELLQuest Pro™, or LYSYS™ II), operates in a "standalone" or automated fashion for analysis. The modification submission primarily relates to sample stability. The study would have evaluated the device's performance in this standalone mode at different time points. The summary does not explicitly detail the performance results beyond stating that "Performance data from validation testing supports equivalency."
7. The Type of Ground Truth Used
For this type of device (flow cytometry reagent for cell enumeration), the "ground truth" for the performance study would typically be established by:
- Comparison to a gold standard method: If a new analysis method were being introduced, it might be compared to a manual reference method or another highly validated flow cytometry method.
- Comparison to the predicate device: For a modification, the stability study would involve comparing the results obtained with the modified device at extended stability times to results obtained with the same device or the predicate device at validated shorter stability times.
- Internal consistency and reproducibility: Ensuring that counts and percentages remain consistent and reproducible over the extended stability period.
The summary does not explicitly state the specific ground truth used, but it would revolve around comparing the measurements (percentages and absolute counts of T cells and T-helper/inducer cells) to established or predicate methods under the new conditions.
8. The Sample Size for the Training Set
The summary does not mention a training set in the context of machine learning or AI, as this is not an AI/ML device. For traditional IVDs, "training set" might refer to data used for initial assay development and optimization, but the 510(k) summary for a device modification typically focuses on validation data.
9. How the Ground Truth for the Training Set Was Established
As no training set (in the AI/ML sense) is mentioned, this question is not applicable.
§ 864.5220 Automated differential cell counter.
(a)
Identification. An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.(b)
Classification. Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”