Definition: To Identify And Classify Cells Or Other Particles In Suspension By Their Inherent Physical Properties Or Associated Fluorescent Molecules In Order To Provide Information About The Distribution Or Number Cells In Suspension Or Their Level Of Protein E
| Device Type ID | 2440 |
| Device Name | Flow Cytometric Reagents And Accessories. |
| Physical State | May Include Flow Cytometers, Monoclonal Antibodies, Lysis Reagents, Processing Reagents, Automated Processing Devices Or Pipetting Devices. |
| Technical Method | Particles In Suspension May Be Treated With Fluorescent Conjugated Antibodies Or Fluorogenic Compounds Followed By Interrogation In A Flow Cytometer That Enumerates And Characterizes Each Particle Based On Its Physical And Fluorescent Characteristics |
| Target Area | Peripheral Whole Blood Specimens, Lymphoid Biopsies, And Neoplastic Tissues. |
| 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 | OYE |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2440 |
| Device | Flow Cytometric Reagents And Accessories. |
| Product Code | OYE |
| 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 | 3 | |
BECKMAN COULTER | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
BECKMAN COULTER, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BECTON, DICKINSON & CO. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
BECTON, DICKINSON AND COMPANY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Device Operational Issue | 30 |
Output Problem | 3 |
Fluid Leak | 2 |
Leak / Splash | 2 |
Pressure Problem | 1 |
Mechanical Problem | 1 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
Charred | 1 |
Thermal Decomposition Of Device | 1 |
Fire | 1 |
| Total Device Problems | 43 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | BD Biosciences, Systems & Reagents | II | Jun-26-2015 |
| 2 | BD Biosciences, Systems & Reagents | II | Jul-02-2014 |
| 3 | Beckman Coulter Inc. | II | Oct-11-2018 |
| 4 | Beckman Coulter Inc. | II | Apr-10-2018 |
| 5 | Beckman Coulter Inc. | II | Sep-19-2017 |
| 6 | Beckman Coulter Inc. | II | Apr-17-2017 |
| 7 | Beckman Coulter Inc. | II | Nov-21-2016 |
| 8 | Beckman Coulter Inc. | II | Sep-28-2016 |
| 9 | Becton, Dickinson And Company, BD Biosciences | III | Feb-01-2019 |
| 10 | Becton, Dickinson And Company, BD Biosciences | III | Jul-13-2018 |