(143 days)
CYTO-STAT® triCHROME™ CD45-FITC/CD19-RD1/CD3-PC5 Monoclonal Antibody Reagent is a three-color fluorescent reagent comprised of three murine monoclonal antibody is labeled with a different color fluorochrome. The reagent allows simultaneous identification of total CD3+ and CD19+ lymphocytes in whole blood by flow cytometry. An isotypic control, CYTO-STAT® triCHROME™ CD45-FITCMsIgG1-PCS, is used to monitor nonspecific staining.
CYTO-STAT® triCHROME™ CD45-FITCMsIgG1-RD1/MsIgG1-PC5 Isotypic Control is a three-color fluorescent reagent comprised of three murine monoclonal antibody is labeled with a different color fluorochrome. This product is intended for use as a quality control reagent to monitor the levels of nonspecific antibody binding in cell surface staining procedures which use CYTO-STAT® triCHROME™ Monoclonal Antibody Reagents comprised of CD45-FITC and two MsIgG1 subclass monoclonal antibodies conjugated to RD1 and PC5.
CD3+ and/or CD19+ lymphocyte percentages and absolute counts may be used as aids to evaluate immune competency underlying known or unknown disease states and to monitor lymphocyte levels following organ transplantation.
To illustrate, identification of abnormal levels of CD3+ lymphocytes may aid in the diagnosis and/or prognosis of unidentified disease conditions in patients with low white blood cell counts. Measurement of CD3+ and/or CD19+ lymphocytes, in conjunction with CD4+ (inducer) and CD8+ (suppressor/cytotoxic) T lymphocytes and corresponding T4/T8 ratios, may aid in the diagnosis and/or prognosis of immunodeficiency disease such as infection with human immunodeficiency virus (HIV), the etiologic agent of acquired immunodeficiency syndrome (AIDS). Altered percentages of CD3+ lymphocytes recorded following organ (for example, kidney, hear, liver, lung) transplantation suggests T and/or B Jymphocyte quantitation may be useful as an aid in monitoring these cellular populations.
As part of a Three Color Lymphocyte Immunophenotyping Panel which includes the NK (Natural Killer) lymphocyte reagent, CYTO-STAT® triCHROME™ CD45-FITC/CD56-RD1/CD3-PCS, CYTO-STAT® triCHROME™ CD45-FITC/CD19-RDI/CD3-PC5 provides the ability to comprehensively identify and enumerate an individual's major lymphocyte subsets: T. B and NK. The reagent also functions as a quality control check for a specimen in terms of total lymphocyte percentage and CD3+ lymphocyte measurements across the panel.
CYTO-STAT® triCHROME™ CD45-FITC/CD19-RD1/CD3-PC5 is a three-color fluorescent reagent comprised of three murine monoclonal antibodies. Each antibody is labeled with a different color fluorochrome. The reagent allows simultaneous identification and enumeration of total CD3+ and CD19+ lymphocytes in whole blood by flow cytometry. An isotypic control. CYTO-STAT® triCHROME™ CD45-FITC/MsIgG1-RD1/MsIgG1-PC5, is used to monitor nonspecific staining.
CYTO-STAT® triCHROME CD45-FITC/MsIgG1-PC5 is a three-color fluorescent reagent comprised of three murine monoclonal antibody is labeled with a different color fluorochrome. This product is intended for use as a quality control reagent to monitor the levels of nonspecific antibody binding in cell surface staining procedures which use CYTO-STAT® triCHROME™ Monoclonal Antibody Reagents comprised of CD45-FITC and two monoclonal antibodies of the MsIgG1 subclass conjugated to RD1 and PC5.
The provided text describes the performance testing for the CYTO-STAT® triCHROME™ CD45-FITC/CD19-RD1/CD3-PC5 Monoclonal Antibody Reagent. The objective of the study was to demonstrate that this new reagent meets performance specifications and provides comparable results to a predicate device, CD3/B4.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state numerical acceptance criteria (e.g., specific percentage agreement or correlation coefficients that must be met). Instead, it describes the types of performance that were evaluated and the conclusion that the device met these specifications.
| Acceptance Criterion | Reported Device Performance | Study Type |
|---|---|---|
| Accuracy: Identifies and enumerates targeted lymphocytes similarly to the predicate device (CD3/B4). | "Results analyzed in terms of minimums, maximums, means ± 1 SD, confidence intervals, regression analyses and analyses of variance demonstrated that CD45/CD19/CD3 and CD3/B4 identify and enumerate essentially identical numbers of the targeted lymphocytes in whole blood specimens." | Comparative (with predicate) |
| Linearity: Maintains accuracy across a range of lymphocyte concentrations. | "Results analyzed in terms of regression and correlation analyses for recovered vs. expected absolute counts demonstrated Linearity of the assay." | Analytical (serial dilution) |
| Precision (Within-Run/Intralaboratory): Consistent results within a single run/laboratory. | "Results analyzed in terms of mean ± 1 SD and CV demonstrated Within Day (Intralaboratory) Precision of the assay." | Analytical (replicate measurements) |
| Precision (Interlaboratory): Consistent results across different laboratories. | "Results analyzed in terms of mean ± 1 SD and CV demonstrated Interlaboratory Precision of the assay." | Analytical (replicate measurements) |
2. Sample Size and Data Provenance
- Test Set Sample Size: For the Accuracy study, "Normal and abnormal whole blood specimens were collected from geographically diverse populations of males and females unselected as to race and ranging in age from 19 to 84 years." The exact number of specimens is not specified in the provided text.
- Data Provenance: The data is prospective, as specimens were collected specifically for this testing. The geographic diversity implies the data is likely from the USA (where Coulter Corporation is headquartered).
3. Number of Experts and Qualifications for Ground Truth
This type of device (monoclonal antibody reagent for flow cytometry) does not typically involve human expert adjudication for establishing ground truth in the same way an imaging device might. The "ground truth" for the comparative effectiveness aspect is the performance of the predicate device (CD3/B4). For linearity and precision studies, the "ground truth" is derived from the expected values based on dilutions or control samples, measured by the flow cytometer itself, without human expert interpretation.
Therefore:
- Number of experts: Not applicable in the context of human interpretation of results.
- Qualifications of experts: Not applicable.
4. Adjudication Method for the Test Set
Not applicable, as the evaluation involves flow cytometry measurements against a predicate device's results and analytical performance metrics, not human adjudication of discrete findings.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not performed. This type of study is more relevant for diagnostic imaging devices where multiple human readers interpret cases. The reported study compares the performance of the new reagent to a predicate reagent using flow cytometry measurements, not human interpretation.
6. Standalone Performance Study
Yes, a standalone performance study was performed in several ways:
- Linearity: The linearity study assesses the algorithm's (flow cytometer's) ability to accurately measure concentrations across a range without comparison to a human reader.
- Precision (Intralaboratory and Interlaboratory): These studies evaluate the consistency and reproducibility of the device's measurements in isolation (though compared across labs for interlaboratory precision).
- While the accuracy study compares to a predicate, the fundamental measurements (CD3+, CD19+ percentages and absolute counts) are generated by the algorithm/device in a standalone fashion. The comparison is between two device-generated outputs.
7. Type of Ground Truth Used
The primary "ground truth" used for Accuracy was the predicate device's performance (CD3/B4) for identifying and enumerating CD3+ and CD19+ lymphocytes. For Linearity, it was the expected absolute counts from serially diluted samples. For Precision, it was the mean and standard deviation of replicate measurements indicating the device's inherent variability.
8. Sample Size for the Training Set
The document does not mention a training set. This product is a reagent for flow cytometry, not an algorithm that requires machine learning training data. The "training" of the system would involve calibration and setup of the flow cytometer itself, not a specific dataset for the reagent.
9. How Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set for a machine learning algorithm.
§ 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.”