(699 days)
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.
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.
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 |
§ 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.”