(97 days)
CYTO-STAT® CD3-FITC/CD56-RD1 Monoclonal Antibody Reagent is a two-color fluorescent reagent comprised of two murine monoclonal antibodies. Each antibody is labeled with a different color fluorochrome. The reagent allows simultaneous identification and enumeration of total CD3+ and CD3-/CD56+ lymphocytes in whole blood by flow cytometry. An isotypic control, CYTO-STAT®/COULTER CLONE® MslgG1-RD1/MsIgG1-FITC, is used to monitor nonspecific staining.
CYTO-STAT®COULTER CLONE® MsIgG1-RD1/MsJgG1-PC5 Isotypic Control is a two-color fluorescent reagent comprised of two 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® or CYTO-STAT®/COULTER CLONE® Monoclonal Antibody Reagents comprised of two MsIgGl subclass monoclonal antibodies conjugated to RD1 and FITC.
CD3+ 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+ lymphocytes, in conjunction with CD4+ (inducer) and CD8+ (suppressor/cytotoxic) T lymphocytes and corresponding T4T8 ratios, may aid in the diagnosis and/or prognosis of immunodeficiency disease such as infection with human immunodeficiency virus (HV), the etiologic agent of acquired immunodeficiency syndrome (AIDS). Altered percentages of CD3+ lymphocytes recorded following organ (for example, kidney, heart, liver, lung) transplantation suggests T lymphocyte quantitation may be useful as an aid in monitoring these cellular populations.
NK (Natural Killer) lymphocyte populations have been functionally defined as a lymphocyte population capable of mediating non-MHC restricted cytoxicity against targets such as certain tumor and virus-infected cells.
As part of a Two Color Lymphocyte Immunophenotyping Panel which includes the B lymphocyte reagent, CYTO-STAT®/COULTER® CLONE® CD3(IgG1)-FITC/B4-RD1, CYTO-STAT® CD3-FITC/CD56-RD1 provides the ability to comprehensively identify and enumerate an individual's major lymphocyte subsets: T, B and NK. The reagent also finctions as a quality control check for a specimen in terms of total lymphocyte percentage and CD3+ lymphocyte measurements across the panel.
CYTO-STAT® CD3-FITC/CD56-RD1 is a two-color fluorescent reagent comprised of two murine monoclonal antibodies. Each antibody is labeled with a different color fluorochrome. The reagent allows simultaneous identification and enumeration of total CD3+ and CD3-/CD56+ lymphocytes in whole blood by flow cytometry. An isotypic control, CYTO-STAT®/COULTER® CLONE® MsIgG1-RD1/MsIgG1-FITC, is used to monitor nonspecific staining.
CYTO-STAT®/COULTER® CLONE® MsIgG1-RD1/MsIgG1-FITC is a two-color fluorescent reagent comprised of two murine monoclonal antibodies. Each 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® OR CYTO-STAT®/COULTER® CLONE® Monoclonal Antibody Reagents comprised of two monoclonal antibodies of the MsIgG1 subclass conjugated to RD1 and FITC.
Acceptance Criteria and Study for CYTO-STAT® CD3-FITC/CD56-RD1 Monoclonal Antibody Reagent
This response describes the acceptance criteria and the study that proves the device meets those criteria, based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy: Identify and enumerate appropriate numbers of targeted lymphocytes (CD3+, CD3-/CD56+, and CD19+) in whole blood specimens. | Achieved: "Results analyzed in terms of minimums, maximums, means ± 1 SD, confidence intervals, regression analyses and analyses of variance demonstrated that CD3/CD56 and CD3/B4 identify and enumerate appropriate numbers of the targeted lymphocytes in whole blood specimens." The device also provides "mature T (CD3+) lymphocyte values comparable to those of CD3/B4" and "appropriate values for NK (CD3-CD56+) and B (CD19+) lymphocytes." |
| Linearity: Demonstrate linearity of the assay for CD3+ and CD3-/CD56+ lymphocyte concentrations across a defined range. | Achieved: "Results analyzed in terms of regression and correlation analyses for recovered vs. expected absolute counts demonstrated Linearity of the assay." |
| Precision (Within Run / Intralaboratory): Demonstrate within-day precision for CD3+ and CD3-/CD56+ lymphocyte concentrations. | Achieved: "Results analyzed in terms of mean ± 1 SD and CV demonstrated Within Day (Intralaboratory) Precision of the assay." |
| Precision (Interlaboratory): Demonstrate interlaboratory precision for CD3+ and CD3-/CD56+ lymphocyte concentrations across different laboratories. | Achieved: "Results analyzed in terms of mean ± 1 SD and CV demonstrated Interlaboratory Precision of the assay." |
2. Sample Size Used for the Test Set and Data Provenance
- Accuracy Study:
- Sample Size: Not explicitly stated as a number, but "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."
- Data Provenance: Prospective collection from "geographically diverse populations" (country of origin not specifically mentioned, but the manufacturer is based in Miami, Florida, USA, and has international affiliates, suggesting a potential for multi-country data, though not confirmed). The data appears to be prospective as specimens were "collected" and "processed as lysed preparations and assayed in parallel."
- Linearity Study:
- Sample Size: A "concentrated COULTER™ CYTO-TROL Cells sample serially diluted to achieve a range of CD3+ and CD3-/CD56+ lymphocyte concentrations." The number of dilutions or individual measurements is not specified beyond "Three replicate measurements."
- Data Provenance: Not explicitly stated, but likely laboratory-generated data using a control sample.
- Precision (Within Run) Study:
- Sample Size: "Ten replicate measurements" for each of CD3+ and CD3-/CD56+ lymphocyte concentrations. The levels were obtained by "selective screening of normal whole blood specimens."
- Data Provenance: Not explicitly stated, but likely laboratory-generated data.
- Precision (Interlaboratory) Study:
- Sample Size: "Ten replicate measurements" on "a single normal whole blood specimen" across "different laboratories."
- Data Provenance: Not explicitly stated, but data from multiple laboratories testing the same specimen.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish ground truth for the test set. The ground truth appears to be based on comparative performance with a legally marketed predicate device (CYTO-STAT®/COULTER CLONE® CD3(IgG1)-FITC/B4-RD1) and established methods (flow cytometry and white blood cell counts/5-part differentials).
4. Adjudication Method for the Test Set
No adjudication method is described or implied in the provided text. The evaluation seems to be based on statistical analyses of the obtained measurements against those from the predicate device and expected biological ranges.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was mentioned. This device is a reagent used in flow cytometry, not an AI-assisted diagnostic tool that would involve human "readers" or AI for image interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a reagent for flow cytometry, not an algorithm. The "performance" described is of the reagent's ability to accurately identify and enumerate cell populations when used with a flow cytometer.
7. The Type of Ground Truth Used
The ground truth for the assessment of the new device (CD3/CD56) was established by comparison to:
- A legally marketed predicate device: "Specimens were assayed with CD3/B4 for comparison purposes." The predicate device is identified as CYTO-STAT®/COULTER CLONE® CD3(IgG1)-FITC/B4-RD1.
- Established clinical methods: "White blood cell counts and 5-part differentials were obtained for all specimens."
- Biological expectations: The goal was to identify and enumerate "appropriate numbers" of targeted lymphocytes.
8. The Sample Size for the Training Set
The document does not describe a "training set" in the context of machine learning or AI. This device is a reagent, and its development would typically involve optimization and validation rather than training in the AI sense.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no mention of a training set for an algorithm in this context. The development process would have involved establishing the optimal antibody concentrations and fluorochrome conjugates for accurate and specific binding.
§ 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.”