(460 days)
Ortho-mune OK-COMBO CD3-FITC/CD4-PE is intended for use in identification and enumeration of CD3+ and CD4+ human T lymphocytes in whole blood by flow cytometry. The intended use is the same as the intended use of the predicate device, Simultest CD3/CD4 (Leu-4/3a) commercially distributed by Becton Dickinson Immunocytometry Systems.
Ortho-mune OK-COMBO CD3-FITC/CD4-PE (OKT3/OKT4A) Monoclonal Antibody (Murine) is a blend of the individual purified monoclonal antibodies OKT3 and OKT4A conjugated to the fluorochromes fluorescein isothiocyanate and phycoerythrin respectively.
The provided text describes a 510(k) summary for the Ortho-mune OK-COMBO CD3-FITC/CD4-PE (OKT3/OKT4A) Monoclonal Antibody (Murine) device, which is intended for the identification and enumeration of CD3+ and CD4+ human T lymphocytes in whole blood by flow cytometry. The study aims to demonstrate substantial equivalence to a predicate device, Simultest™ CD3/CD4 Ortho-mune™ OK-COMBO (Leu™-4 / 3a) CD3-FITC/CD4-PE (OKT™3 /OKT4A) Monoclonal Antibody (Murine).
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Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by achieving a statistically significant correlation between the performance of the new device (Ortho-mune OK-COMBO CD3-FITC/CD4-PE) and the predicate device (Simultest CD3/CD4), as well as between different flow cytometers used with the new device. The benchmark for significance is a p-value (SL) of 0.0001, indicating a very high probability of correlation. The Pearson Product Moment Correlation Coefficient is the metric used to assess this.
Table 1: Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance (Correlation Coefficient) |
|---|---|---|
| Normal Donors (N=202) | Pearson Correlation significantly high (e.g., SL |
§ 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.”