(155 days)
For flow cytometer set up and monitoring of instrument performance prior to performing reticulocyte ennumeration or immunophenotyping applications. Flow cytometry has been found useful in monitoring some forms of immune disease.
For the FACS® family of flow cytometers (FACScan, FACSort and FACSCalibur).
An accessory device for instrument setup prior to performing reticulocyte ennumeration and immunophenotyping.
For adjusting instrument settings: aligning the signal from the blue and the optional red laser (FL4 Option), setting the photomultiplier tube (PMT) voltages, and monitoring instrument performance over time.
For automatically setting the fluorescence compensation of the detectors to adjust for spectral overlap of fluorescent signals.
For monitoring the sensitivity of the side scatter (SSC) and fluorescence (FLI, FL2, FL3, and FL4) detectors and verifying adequate separation of system noise from forward scatter (FSC) signals.
For in vitro diagnostic use.
Becton Dickinson FACSComp software and the CaliBRITE 4 bead kir (FACSComp/CaliBRITE 4) are intended for use on the Becton Dickinson flow cytometers, FACSort™ or FACSCalibur™, equipped with the FL4 Option. FACSComp/CaliBRITE 4 are used to check laser alignment, optimally adjust instrument settings, monitor sensitivity, and to set the compensation of flow cytometers for spectral overlap of fluorescent dyes. FACSComp/CaliBRITE 4 are used to set up and verify the separation of system noise from forward and side scatter and to set fluorescence compensation on flow cytometers with four fluorescence (FL) channels FACSComp/CaliBRITE 4 is used for setting the photomultiplier tube (PMT) voltages, setting the fluorescence compensation, and checking instrument sensitivity on flow cytometers. This product is recommended for instrument set up prior to running Becton Dickinson software applications for flow cytometers. The CaliBRITE beads are provided as a separate vial of CaliBRITE APC beads and the four-vial CaliBRITE 3 kit, comprised of unstained, FITC-, PE- and PerCP-labeled beads.
The provided text describes the Becton Dickinson Immunocytometry Systems (BDIS) CaliBRITE™ APC beads, CaliBRITE 4 kit, and FACSComp™ software. This 510(k) submission (K973483) specifically aims to demonstrate substantial equivalence to a predicate device, the CaliBRITE™ 3 kit and FACSComp™ software (K961623).
The summary indicates that the new device is essentially the predicate device plus an additional component, the CaliBRITE APC beads, designed to facilitate the setup of the FL4 Option on certain flow cytometers. Due to this nature, the "acceptance criteria" and "device performance" are framed around demonstrating equivalence to the predicate device and the stability and reproducibility of the new components/system.
Here’s a breakdown of the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly tied to the performance of the predicate device and the stability/reproducibility of the new system. The document does not explicitly list numerical acceptance criteria with target values. Instead, it states that the performance was "equivalent to the predicate device" for reproducibility aspects and provides stability durations.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Stability (Storage of Beads) | 8 months under conditions of use |
| Stability (Diluted CaliBRITE APC and unlabeled beads - Tube A) | 8 hours after dilution |
| Stability (Diluted five-bead preparation - Tube B) | 1 hour after dilution |
| Reproducibility (Between bead lots) | Equivalent to the predicate device |
| Reproducibility (Within instrument across two computer platforms) | Equivalent to the predicate device |
| Reproducibility (Within setup options: lyse and wash (L/W) and lyse no wash (LNW) across colors) | Equivalent to the predicate device |
| Reproducibility (Between manual and automated 4-color LNW setup options) | Equivalent to the predicate device |
| Reproducibility (Within instrument over 20 days) | Equivalent to the predicate device |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the sample size (number of runs, number of beads tested, etc.) for the reproducibility or stability studies. It only mentions "Several studies were performed."
- Data Provenance: The testing was "at Becton Dickinson Immunocytometry Systems laboratories in San Jose, California." This indicates the data is retrospective (performed as part of device development/verification) and from a single country of origin (USA).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This type of device (flow cytometer calibration beads and software) does not typically involve human expert interpretation for establishing "ground truth" in the way, for example, an imaging diagnostic AI would. The "ground truth" here is the expected performance of a well-calibrated flow cytometer, based on physical and chemical properties of the beads and the instrument's known specifications.
4. Adjudication Method for the Test Set
Not applicable. As noted above, human adjudication is not relevant for this type of device and its performance evaluation.
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 focuses on human reader performance with and without AI assistance, which is not relevant for a calibration product like the CaliBRITE system.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The device is a calibration system used to set up and monitor flow cytometers. The FACSComp software automates certain tasks (e.g., setting PMT voltages, fluorescence compensation), which could be considered an "algorithm only" component in its execution of these tasks. However, its overall function is to prepare the instrument for human operators to then run diagnostic tests. The performance data presented focuses on the consistency and stability of this automated setup. It isn't a standalone diagnostic algorithm that produces a medical output without human oversight of the instrument's readiness.
7. The Type of Ground Truth Used
The ground truth used for these studies is based on:
- Instrument Specifications: The expected ideal readings for properly calibrated flow cytometers using the CaliBRITE beads.
- Predicate Device Performance: The established performance characteristics of the CaliBRITE 3 kit and FACSComp software (K961623) served as the benchmark for "equivalence."
- Physical/Chemical Properties: The known characteristics of the fluorescent beads themselves (e.g., their fluorescence intensity) are inherent ground truth for their intended use in calibration.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML model in the contemporary sense that requires a "training set" of data. It's a calibration system whose "logic" or algorithms are based on established flow cytometry principles, not on learned patterns from a large dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of this device.
§ 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.”