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Ortho-mune OK-COMBO Control is intended for use as negative control for immunophenotying of human lymphocytes in whole blood by flow cytometry using Orthomune OK-COMBO immunophenotyping reagents. Ortho-mune OK-COMBO immunophenotyping reagents are blends of two purified monoclonal antibodies conjugated to fluorescein isothiocyanate and phycoerythrin, respectively. The negative control is used to check for nonspecific background staining and to set the negative/positive rergions of the fluorescent cytograms.

Device Description

Ortho-mune OK-COMBO Control IgG2-FITC/IgG2-PE Monoclonal Antibody (Murine) is a blend of murine monoclonal antibodies, not specific for human cellular antigens, conjugated to the fluorochromes, fluorescein isothiocyanate (FITC) and phycoerythrin (PE), respectively.

AI/ML Overview

Here's an analysis of the provided text, outlining the acceptance criteria and study details for the Ortho-mune™ OK-COMBO Control IgG2-FITC/IgG2-PE Monoclonal Antibody (Murine):

Device: Ortho-mune™ OK-COMBO Control IgG2-FITC/IgG2-PE Monoclonal Antibody (Murine)
Intended Use: Negative control for immunophenotyping of human lymphocytes in whole blood by flow cytometry using Ortho-mune OK-COMBO immunophenotyping reagents. Used to check for non-specific background staining and to set negative/positive regions of fluorescent cytograms.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" with numerical thresholds for performance. Instead, the study aims to demonstrate substantial equivalence to a predicate device (Simultest™ IMK Plus Reagent B-Control) and acceptable reproducibility and linearity. Therefore, the "acceptance criteria" are implied by the comparative performance and good internal consistency.

Performance Metric	Acceptance Criteria (Implied by Equivalence/Acceptability)	Reported Device Performance (Ortho-mune OK-COMBO Control)
Equivalence to Predicate Device
Mean % Events in Positive Region (Normal Donors)	Similar mean % and range as the predicate (Simultest IMK Control), with small ΔMean and CI. (e.g., ΔMean approaching 0, CI covering 0).	FITC: Mean 0.32% (SD 0.50, Range 0-1.32). ΔMean vs. predicate: 0.07 (CI 0.07).
		PE: Mean 0.38% (SD 0.78, Range 0-1.95). ΔMean vs. predicate: 0.13 (CI 0.12).
Mean % Events in Positive Region (AIDS/ARC Patients)	Similar mean % and range as the predicate (Simultest IMK Control), with small ΔMean and CI.	FITC: Mean 0.43% (SD 0.34, Range 0-1.10). ΔMean vs. predicate: 0.11 (CI 0.08).
		PE: Mean 0.44% (SD 0.56, Range 0-1.55). ΔMean vs. predicate: 0.13 (CI 0.12).
Reproducibility
Within Laboratory Reproducibility (CV)	Low coefficient of variation (CV) across different sample types, suggesting consistent results within a laboratory. (No specific threshold given, but values generally below ~1% are good in flow cytometry).	CD19 Depleted: 0.403%. CD4 Depleted: 0.151%. CD8 Depleted: 0.084%. Normal: 0.215%. (These are "All Sites" CVs based on aggregated variance; individual site CVs are lower).
Between Laboratory Reproducibility (CV)	Low coefficient of variation (CV) across different laboratories, suggesting consistent results between labs. (No specific threshold given, but generally <5% is considered good for inter-lab variability).	CD19 Depleted: 0.024%. CD4 Depleted: 0.052%. CD8 Depleted: 0.028%. Normal: 0.023%.
Linearity (Ortho-mune OK-COMBO Control with OK-COMBO Reagents)	Slope close to 1, intercept close to 0, and high correlation coefficient (R close to 1) for various lymphocyte subsets (CD3+CD4+, Total CD19+), indicating accurate measurement across a broad range.	CD3+CD4+: Slope = 0.999 (CI 0.002), Intercept = 6.516 (CI 3.118), R = 1.000 (All Donors). Individual donor slopes range from 0.999-1.000, R=1.000.
		TOTAL CD19+: Slope = 1.003 (CI 0.008), Intercept = -5.916 (CI 4.016), R = 1.000 (All Donors). Individual donor slopes range from 1.002-1.007, R=1.000.
Concomitant use with Ortho-mune Reagents vs. Predicate Reagents	Ortho-mune reagents with OK-COMBO Control should yield equivalent mean % and range of positive stained cells compared to Simultest reagents with their control.	The tables G-J (Normal Donors, AIDS/ARC Patients) and M-N (FACScan Comparison) generally show very similar mean percentages and overlapping ranges for comparable markers (e.g., OKT3 vs. LEU4, OKB19A vs. LEU12, OKT4A vs. LEU3a, OKT8 vs. LEU2a) between the OK-COMBO system and the Simultest system. The document concludes "These data demonstrate equivalent performance."
Performance across different Flow Cytometers	Ortho-mune OK-COMBO reagents with OK-COMBO Control should yield equivalent mean % and range of positive stained cells when run on ORTHO CYTORONABSOLUTE and FACScan.	Tables K and L show comparable mean percentages and overlapping ranges for OKT3, OKB19A, OKT4A, and OKT8 when analyzed on both ORTHO CYTORONABSOLUTE and FACScan.

2. Sample Size Used for the Test Set and Data Provenance

Equivalence to Predicate Device (Percent of Events in Positive Region):
- Normal Donors: N = 203 whole blood specimens.
- AIDS/ARC Patients: N = 84 whole blood specimens.
- Provenance: "three external, geographically distinct sites." Implies prospective collection, but not explicitly stated. Country of origin not specified.
Reproducibility Studies:
- N = 11 donors (processed to produce CD4 depleted, CD8 depleted, CD19 depleted, and normal sample types).
- Number of Replicates: 10 replicates per sample type per site for within-laboratory, aggregated results for between-laboratory.
- Provenance: "three independent laboratories." Implies prospective collection. Country of origin not specified.
Linearity Study:
- N = 4 normal donor samples (whole blood, EDTA) processed to generate low, normal, and high numbers of lymphocyte subsets.
- Number of Replicates: Triplicate staining for each sample.
- Provenance: Normal donor samples; not explicitly stated if from external sites or internal. Country of origin not specified.
Comparison of Ortho-Mune Reagents + Control vs. Predicate Reagents + Control:
- Normal Donors (Tables G, H): N = 191 (CD3/CD19), N = 190 (CD4/CD8) whole blood specimens.
- AIDS/ARC Patients (Tables I, J): N = 85 (CD3/CD19), N = 83 (CD4/CD8) whole blood specimens.
- FACScan Comparison (Tables K, L, M, N): N = 29 (OKT3/OKB19A), N = 49 (OKT4A/OKT8) normal donor whole blood samples.
- Provenance: Not explicitly stated for all these specific comparisons, but generally "Whole blood specimens from normal donors and AIDS/ARC patients" were used.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This study does not involve "experts" establishing a disease diagnosis or image ground truth for the test set. Instead, it involves laboratory measurements using flow cytometry. The accuracy of the measurements relies on the instrument (ORTHO CYTORONABSOLUTE laser flow cytometer) and established laboratory protocols for staining and analysis. The "ground truth" for the test samples in the linearity study, for example, was derived from automated hematology analyzers and further calculations based on dilutions and flow cytometry results (expected X-axis values).

4. Adjudication Method for the Test Set

Not applicable. This is a technical performance study of a control reagent in a laboratory setting, not a clinical study requiring expert adjudication of diagnoses.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, this is not an MRMC study. It is a technical performance study of a laboratory reagent demonstrating equivalence to a predicate and acceptable performance characteristics. It does not involve human readers interpreting results with or without AI assistance.

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

Yes, the study primarily evaluates the standalone performance of the Ortho-mune OK-COMBO Control reagent in conjunction with flow cytometers. The primary data presented (mean percentages, ranges, reproducibility CVs, linearity slopes/intercepts/R-values) are objective measurements generated by the instruments and the reagents, not subject to human interpretation in the sense of a diagnostic decision. The device itself is a "negative control" reagent, used for instrument calibration and assessment of non-specific staining, rather than a diagnostic algorithm that produces an output for human interpretation.

7. The Type of Ground Truth Used

The ground truth is based on:

Comparative Performance: The established performance data of the legally marketed predicate device, Simultest™ IMK Plus Reagent B-Control. The goal is to show the new device produces equivalent results.
Internal Consistency: For reproducibility and linearity, the "ground truth" is derived from consistency across replicates, laboratories, and expected values based on known dilutions or physiological ranges (e.g., in normal vs. AIDS/ARC patient samples).
Instrument Measurements: The quantitative outputs from the ORTHO CYTORONABSOLUTE laser flow cytometer and automated hematology analyzers.

8. The Sample Size for the Training Set

Not applicable. This is a performance study for a laboratory reagent. There is no "training set" in the context of machine learning or AI algorithms; the reagents are chemical/biological products whose performance characteristics are intrinsically determined by their composition and manufacturing process.

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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