MAM · Dna-Probe, B And T Lymphocyte
Hematology · 21 CFR 864.5220 · Class 2
Overview
| Product Code | MAM |
|---|---|
| Device Name | Dna-Probe, B And T Lymphocyte |
| Regulation | 21 CFR 864.5220 |
| Device Class | Class 2 |
| Review Panel | Hematology |
| 3rd-Party Reviewable | Yes |
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.”
Special Controls
*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.”
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K923951 | CD8 CYTOSPHERES KIT | Coulter Electronics, Inc. | Apr 25, 1994 | SESE |
| P880016 | ONCOR B/T GENE REARRANGEMENT TEST | Oncor, Inc. | Oct 10, 1989 | APPR |
Top Applicants
- Coulter Electronics, Inc. — 1 clearance
- Oncor, Inc. — 1 clearance
