Definition: An Automated Multicolor Fluorescent Imaging Cytometer And Absorbance Spectrometer Which Utilizes Specific Single-use Reagent Cartridges To Identify And Enumerate Specific Hematologic Subpopulations And Parameters (e.g., Hemoglobin) Using Spectrophoto
| Device Type ID | 2447 |
| Device Name | Automated Multicolor Fluorescent Imaging Cytometric Analysis System |
| Physical State | System May Include Image Cytometer, Assay-specific Single-use Reagent Cartridges And Reagents, Specimen And Process Controls, Dedicated Instrument Control, Data Acquisition Software And Other Essential Hardware Components. |
| Technical Method | System Identifies And Enumerates Specific Leukocyte Populations Using Immunophenotyping Methods And Image Cytometry. System Performs Quantification And Enumeration Of Cells Using Specific Fluorescently Labeled Conjugated Antibodies To Bind To Leukocy |
| Target Area | Human Whole Blood |
| Regulation Description | Automated Differential Cell Counter. |
| Regulation Medical Specialty | Hematology |
| Review Panel | Hematology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 864.5220 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PMG |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2447 |
| Device | Automated Multicolor Fluorescent Imaging Cytometric Analysis System |
| Product Code | PMG |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Automated Differential Cell Counter. |
| CFR Regulation Number | 864.5220 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BECTON, DICKINSON & CO. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BECTON, DICKINSON AND COMPANY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |