(247 days)
The beads are for use on a BD FACSCanto™ flow cytometer equipped with BD FACSCanto software. The beads are used to adjust detector voltages, to set fluorescence compensation and to monitor daily instrument performance. For In Vitro Diagnostic Use.
BD FACS 7-color setup beads are intended for use on the BD FACSCanto flow cytometer equipped with a 488-nm blue laser, a 633-nm red laser, and six fluorescence detectors. BD FACS 7-color setup beads are provided as a lyophilized pellet contained in 25 individually packaged test tubes along with a bottle of BD FACS setup bead diluent.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Storage Stability (Beads) | 7 months at 2-8°C |
| Stability (Diluted Mixed-Bead Preparation) | 1 hour at 20-25°C or 8 hours at 2-8°C |
| Reproducibility (Between three bead lots) | Equivalent to the predicate device |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a distinct "test set" sample size. The reproducibility study was conducted using "three bead lots," which serves as the sample size for evaluating lot-to-lot consistency. The data provenance is Becton Dickinson Immunocytometry Systems laboratories in San Jose, California, suggesting a prospective, in-house study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This document does not indicate the involvement of external experts to establish ground truth for a test set. The performance data seems to be based on internal laboratory testing and comparison to a predicate device.
4. Adjudication Method for the Test Set:
Not applicable, as there is no mention of a ground truth established by experts or a need for adjudication in the provided text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
Not applicable. This device is a set of quality control beads for a flow cytometer, not an AI-assisted diagnostic tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This is a physical product (beads) for instrument setup and monitoring, not an algorithm.
7. The Type of Ground Truth Used:
The ground truth for performance evaluation appears to be based on established laboratory testing methods for stability and reproducibility, with a comparison to the performance of a legally marketed predicate device (CaliBRITE™ beads).
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. This device is not an AI algorithm that requires a training set.
§ 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.”