(112 days)
For the FACS® family of flow cytometers equipped with a blue (488-nm) and a red t diode (635-nm) laser.
A monoclonal antibody reagent for identification and enumeration of mature human T . lymphocyte subsers in human peripheral blood.
For use with crythrocyte lysed whole blood. .
To characterize and monitor forms of autoimmune diseases, such as lupus. .
To characterize and monitof congenital or acquired immunodeficiencies, such as . SCID or AIDS.
For in vitro diagnostic use.
The Becton Dickinson CD3 fluorescein isothiocyanate (FITC)/CD8 phycoerythrin (PE)/CD45 peridinin chlorophyll protein (PerCP)/CD4 allophycocyanin (APC) reagent is a four-color, direct immunofluorescence reagent for identifying and enumerating percentages of CD3+ T Lymphocytes, CD3+CD4+ helper/inducer, and CD3+CD8+ suppresser/cyroroxic T-Lymphocyte subscts in erythrocyce-lysed whole blood. Each vial of reagent yields 50 tests. The reagent is intended for use on the Becton Dickinson FACSCalibur 10 flow cycomerers equipped with the FL4 Option, the Apple Macintosh Quadra or PowerPC computer, and CELLQuest or MultiSET software. Daily instrument set-up requires CaliBRITE beads (unlabeled, FITC, PE, Per CP, and APC) and FACSComp software.
Here's an analysis of the provided text to extract the acceptance criteria and supporting study details:
Note: The provided document is a 510(k) summary for a medical device (MultiTEST CD3/CD8/CD45/CD4 reagent). These summaries often focus on demonstrating substantial equivalence to a predicate device rather than explicitly stating pre-defined "acceptance criteria" and then proving each one. Instead, they describe performance testing to show the new device is "as safe and effective" as the predicate. Therefore, the "acceptance criteria" in this context are interpreted from the performance claims and the comparison to an equivalent device. The "reported device performance" is the general finding of "acceptable" or "equivalent" performance in each study.
Acceptance Criteria and Study Details for MultiTEST CD3/CD8/CD45/CD4 Reagent
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Accuracy: Equivalence to predicate three-color reagents (TriTEST CD3/CD8/CD45 and TriTEST CD3/CD4/CD45). | Demonstrated equivalence to predicate devices (MultiTEST CD3/CD45/CD4 is equivalent to TriTEST CD3/CD8/CD45 and TriTEST CD3/CD4/CD45). |
| Within-site Reproducibility: Acceptable variability in T-cell count measurements at a single site. | Demonstrated acceptable within-site reproducibility. |
| Across-site Reproducibility: Acceptable variability in T-cell count measurements across multiple sites. | Demonstrated acceptable across-site reproducibility. |
| Stability (Whole Blood Storage): Acceptable performance for samples stored up to 48 hours after blood draw. | Demonstrated acceptable stability of samples prepared up to 48 hours after blood draw. |
| Stability (Stained Sample Storage): Acceptable performance for stained samples acquired up to 24 hours after preparation. | Demonstrated acceptable stability of prepared samples up to 24 hours after preparation. |
| Linearity and Recovery: Linear response and acceptable recovery over a specified range of WBC and lymphocyte counts. | Indicated linear response over the range of 200-29,700 WBC/uL and 100-9000 Lymphocytes/uL, with acceptable recovery. |
| Overall Equivalence: As safe and effective as the predicate devices, sharing the same intended uses and methodologies. | The device is as safe and effective as the predicate device; products yield essentially equivalent performance characteristics. |
2. Sample Size and Data Provenance for Test Set
- Accuracy Study: 129 specimens (70 normal, 59 abnormal).
- Within-site Reproducibility Study: 9 donors (3 normal, 6 abnormal), with each specimen divided into 10 aliquots (total 90 samples tested).
- Across-site Reproducibility Study: 46 donors (15 normal, 31 abnormal), with each specimen divided into 5 aliquots (total 230 samples tested).
- Stability Studies: 30 donors (10 normal, 20 abnormal).
- Linearity and Recovery Study: 3 normal donors.
Data Provenance: The studies were performed at:
- Children's Memorial Hospital, Chicago, Illinois (USA)
- Covance Central Laboratory, Indiana (USA)
- Cleveland Clinic Foundation, Cleveland, Ohio (USA)
- Becton Dickinson Immunocytometry Systems, San Jose, California (USA)
The data appears to be prospective for the purpose of demonstrating device performance, as these were specific studies designed for the 510(k) submission.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
The document does not explicitly state the number of experts or their qualifications for establishing ground truth for the test set in the conventional sense of human readers for an image. For flow cytometry, "ground truth" is typically established by the reference method (e.g., the predicate device or a clinical laboratory's established procedures for manual cell counting/analysis) and the technical accuracy of the instrument. The "performance data" section describes the studies comparing the new device against the predicate or expected biological ranges.
4. Adjudication Method (Test Set)
Not applicable. This is not a study requiring adjudication by human readers for diagnostic interpretation. The "adjudication" is internal to the flow cytometer's software (MultiSET software's single-tube fluorescence gating and automated quality control algorithms) and comparison to predicate device results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for imaging diagnostics where human readers interpret images with and without AI assistance. This device is a diagnostic reagent for flow cytometry, which involves automated enumeration of cell populations rather than human interpretation of complex images.
6. Standalone Performance Study
Yes, a standalone performance was done for various aspects of the device's function:
- Accuracy: Comparing the new 4-color reagent to the predicate 3-color reagents using the same specimen.
- Reproducibility (within-site and across-site): Assessing the consistency of results generated by the device.
- Stability: Evaluating the device's performance under different storage conditions.
- Linearity and Recovery: Determining the device's ability to accurately measure cell concentrations across a range.
These studies assess the device's performance in isolation with human involvement mainly in sample preparation and operation.
7. Type of Ground Truth Used
The primary ground truth used for the performance studies was comparison to a legally marketed predicate device. Specifically:
- For accuracy, the results from the new device (MultiTEST CD3/CD45/CD4) were compared to those obtained using the predicate devices (TriTEST CD3/CD8/CD45 and TriTEST CD3/CD4/CD45).
- For other performance metrics (reproducibility, stability, linearity), the ground truth was implied by the expected biological ranges for "normal" and "abnormal" donors and the device's ability to consistently and accurately measure these populations against established laboratory methods.
8. Sample Size for the Training Set
The document does not provide information on a specific "training set" for an algorithm in the way that an AI deep learning model would have. The "MultiSET software" includes automated quality control algorithms, but no details are given about a distinct training set for these algorithms. The development of such software would have involved internal validation and calibration using various samples, but this information is not disclosed in the 510(k) summary.
9. How Ground Truth for the Training Set Was Established
As no specific training set is outlined in the document, how ground truth for such a set was established is not provided. If the "MultiSET software" involved machine learning or complex algorithms, its development would have required internal validation and calibration, likely using well-characterized samples or a gold standard method. However, this is outside the scope of the information provided in the 510(k) summary.
§ 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.”