21 CFR 864.5220 — Counter, Differential Cell
Hematology (HE) · Part 864 Subpart F—Automated and Semi-Automated Hematology Devices · § 864.5220
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.
Classification Rationale
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.”
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GKZ | Counter, Differential Cell | 2 | 379 | |
| LIZ | Assay, T Lymphocyte Surface Marker | 2 | 7 | 3rd Party |
| LJD | Assay, B Lymphocyte Marker | 2 | 1 | 3rd Party |
| MAM | Dna-Probe, B And T Lymphocyte | 2 | 2 | 3rd Party |
| NID | Assay, Proliferation, In Vitro, T Lymphocyte | 2 | 2 | 3rd Party |
| OYE | Flow Cytometric Reagents And Accessories. | 2 | 8 | 3rd Party |
| PDX | Flow Cytometry Calibrator | 2 | 0 | 3rd Party |
| PMG | Automated Multicolor Fluorescent Imaging Cytometric Analysis System | 2 | 1 | SaMD, 3rd Party |
| POV | Semen Analysis Device | 2 | 28 | 3rd Party |
Special Controls
GKZ — Counter, Differential Cell
*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.”
eCFR
GKZ — Counter, Differential Cell
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.”
Ecfr Llm
LIZ — Assay, T Lymphocyte Surface Marker
*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.”
eCFR
LJD — Assay, B Lymphocyte Marker
*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.”
eCFR
MAM — Dna-Probe, B And T Lymphocyte
*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.”
eCFR
NID — Assay, Proliferation, In Vitro, T Lymphocyte
*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.”
eCFR
OYE — Flow Cytometric Reagents And Accessories.
*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.”
eCFR
PDX — Flow Cytometry Calibrator
*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.”
eCFR
PMG — Automated Multicolor Fluorescent Imaging Cytometric Analysis System
*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.”
eCFR
POV — Semen Analysis Device
*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.”
eCFR
