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CALTAG CD3/CD19/CD45 is a fluorescent reagent containing a combination of CD3. CD19 and CD45 monoclonal antibodies conjugated to fluorescein. phycoerythrin and the tandem fluorochrome PE-Cy5, respectively, This reagent permits the simultaneous identification of CD3+ mature T lymphocytes, CQ19+ inature Bilymphocytes, and CD45+ leukocytes including lymphocytes, monocytes and granulocytes, by flow cytometric methods.

The CALTAG CD3/CD19/CD45 monoclonal antibody combination binds to the surfaces of viable blood cells that express the corresponding antigens. To identify cells bearing these antigenic determinants, peripheral blood leukocytes are incubated with the monoclonal antibody, and washed to remove unbound antibody. Prior to removal of unbound antibody, lysis solution is added to lyse red blood cells. An appropriate fixative solution is added to lysed and washed cells. Stained and fixed cells are subsequently analyzed by flow cytometric methods.

The document provided describes the Caltag CD3 FITC/CD19 R-PE/CD45 TRI-COLOR™ Mouse Monoclonal Antibody Combination and its substantial equivalence to predicate devices and single antibody components. It outlines non-clinical and clinical tests conducted to support this claim.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state formal "acceptance criteria" in a pass/fail format with specific thresholds. Instead, it presents data to demonstrate substantial equivalence through comparisons (expected values, specificity, and correlation) to predicate devices and single antibody components. The "performance" is the reported mean percentage of positive cells and correlation statistics.

Below is a summary of the relevant performance characteristics presented. The "Acceptance Criteria" are implied by the equivalency claims and strong correlations observed.

Correlation (vs. Caltag CD3 FITC single antibody):

• Mean % positive (component): 69.7%
• Mean % positive (single): 68.3%
• r² value: 94.8%
• Slope: 1.01
• Y intercept: 0.33
• Linear regression: y = 0.33 + 1.01x |
  | Expected Value (CD19 R-PE component) | Range of positive cells for healthy normal donors should be comparable to single CD19 R-PE antibody (Caltag & Coulter). | Device Combination: 13.3% ± 4.5 (Range: 4-22%) for 155 normal donors.
  Single Antibody (Caltag CD19 R-PE): 13.0% ± 4.2 (Range: 5-21%) for 155 normal donors.

Correlation (vs. Caltag CD19 R-PE single antibody):

• Mean % positive (component): 16.8%
• Mean % positive (single): 16.4%
• r² value: 98.9%
• Slope: 1.02
• Y intercept: 0.08
• Linear regression: y = 0.08 + 1.02x

Correlation (vs. Coulter CD19 RD1 single antibody):

• Mean % positive (component): 16.8%
• Mean % positive (Coulter): 16.2%
• r² value: 98.1%
• Slope: 0.95
• Y intercept: 1.29
• Linear regression: y = 1.29 + 0.95x |
  | Expected Value (CD45 TRI-COLOR component) | Range of positive cells for healthy normal donors should be comparable to single CD45 TRI-COLOR antibody. | Device Combination: 100.0% ± 0.1 (Range: 100-100%) for 155 normal donors.
  Single Antibody (Caltag CD45 TRI-COLOR): 99.0% ± 0.9 (Range: 97-100%) for 40 normal donors. (Again, indicating comparable performance). |
  | Specificity (CD3 FITC) | Low non-specific binding to monocytes, granulocytes, platelets, and RBCs. | Mean non-specific binding:
• Monocytes: 1.4%
• Granulocytes: 0.8%
• Platelets: 0.4%
• RBCs: 0.3% (Very low, suggesting good specificity). |
  | Specificity (CD19 R-PE) | Low non-specific binding to monocytes, granulocytes, platelets, and RBCs. | Mean non-specific binding:
• Monocytes: 0.8%
• Granulocytes: 0.5%
• Platelets: 0.3%
• RBCs: 0.3% (Very low, suggesting good specificity). |
  | Specificity (CD45 TRI-COLOR) | High specific binding to lymphocytes, monocytes, and granulocytes; low non-specific binding to platelets and RBCs. | Mean specific binding:
• Lymphocytes: 100.0%
• Monocytes: 100.0%
• Granulocytes: 100.0%
  Mean non-specific binding:
• Platelets: 0.5%
• RBCs: 0.3% (Excellent specific binding to target leukocytes and very low non-specific binding). |
  | Correlation (General) | Strong correlation (high r² value, slope near 1, y-intercept near 0) between the component antibodies in the combination and their respective single antibody counterparts, indicating equivalent performance in quantifying cell populations. | r² values of 94.8% (CD3), 98.9% (CD19 vs Caltag single), and 98.1% (CD19 vs Coulter single) are all very high, demonstrating strong correlation. Slopes are close to 1 (1.01, 1.02, 0.95) and Y-intercepts are close to 0 (0.33, 0.08, 1.29), supporting substantial equivalence. |

2. Sample size used for the test set and the data provenance:

• Expected Value Study:
  • Sample Size: 155 apparently healthy normal donors (16 to 72 years old, mean age 41).
  • Data Provenance: Prospective collection from geographically diverse areas of the United States (Eastern, SouthCentral, and Western regions). The study was conducted in three independent laboratories. The population included adult Caucasians, Blacks, Orientals, and Hispanics.
• Specificity Study:
  • Sample Size: Not explicitly stated as a distinct number, but "blood samples were obtained from healthy normal donors of Caucasian, Black, Hispanic and Oriental ethnic origins." At least 5 donors are represented in the tables (one for each ethnic origin listed).
  • Data Provenance: Healthy normal donors of various ethnic origins.
• Correlation Study:
  • Sample Size: 175 donors (including 155 normal and 20 abnormal donors). This seems to be a mixed prospective/retrospective set or a different prospective collection from the "expected value" study, as the previous one only mentioned normal donors.
  • Data Provenance: Not explicitly detailed beyond "donors." Given the context of healthy normals and ethnically diverse data in the expected value study, it's likely similar.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This device is a reagent for flow cytometry, which quantifies cell populations based on antibody binding. The "ground truth" here is the physical presence of the antigens on the cells and their subsequent detection by flow cytometry. There is no mention of experts establishing a visual "ground truth" like in imaging studies. The accuracy of the flow cytometer's measurements, itself, establishes the "ground truth" for quantification based on the reagents' performance. The comparison is made against established single antibodies (predicate devices), implying that their performance is the accepted standard.

4. Adjudication method for the test set:

Not applicable. This is not a study requiring adjudication of expert interpretations, but rather a quantitative measurement of antibody binding and cell population percentages by flow cytometry.

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:

Not applicable. This document describes an in vitro diagnostic reagent, not an AI or imaging device that involves human readers or an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The device itself is a reagent kit. Its performance is evaluated in a standalone manner as an IVD product (antibody binding to cells), without human interpretation as the primary outcome measure. The flow cytometer, an automated instrument, performs the analysis.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" is implicitly established by:

• Known antigen expression: CD3 on T lymphocytes, CD19 on B lymphocytes, CD45 on all leukocytes.
• Flow cytometry measurements: The quantification of positive cell populations by the flow cytometer, using the combination reagent compared to established single reagents. The specificity data further supports this by showing where the antibodies do and do not bind.
• Predicate device performance: The performance of the predicate single antibodies serves as the accepted standard for defining the "true" percentages of cell populations.

8. The sample size for the training set:

The concept of "training set" is not applicable in the context of this traditional IVD reagent validation. This is a chemical reagent, not an algorithmic model that learns from data.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for this type of device.

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