GKL · Counter, Cell, Automated (Particle Counter)
Hematology · 21 CFR 864.5200 · Class 2
Overview
| Product Code | GKL |
|---|---|
| Device Name | Counter, Cell, Automated (Particle Counter) |
| Regulation | 21 CFR 864.5200 |
| Device Class | Class 2 |
| Review Panel | Hematology |
| 3rd-Party Reviewable | Yes |
Identification
An automated cell counter is a fully-automated or semi-automated device used to count red blood cells, white blood cells, or blood platelets using a sample of the patient's peripheral blood (blood circulating in one of the body's extremities, such as the arm). These devices may also measure hemoglobin or hematocrit and may also calculate or measure one or more of the red cell indices (the erythrocyte mean corpuscular volume, the mean corpuscular hemoglobin, or the mean corpuscular hemoglobin concentration). These devices may use either an electronic particle counting method or an optical counting method.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 130)
Showing 20 most recent of 130 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K152776 | Glocyte Automated Cell Counter System | Advanced Instruments, Inc. | May 27, 2016 | SESE |
| K091539 | IQ 200 URINE ANALIZER BODY FLUIDS MODULE | Iris Diagnostics | Aug 31, 2010 | SESE |
| K071652 | HEMOCUE WBC SYSTEM | Hemocue AB | Oct 25, 2007 | SESE |
| K051693 | MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM | Bayer Healthcare, LLC | Dec 7, 2005 | SESE |
| K050235 | IQ 200 URINE ANALYZER BODY FLUIDS MODULE | Iris International, Inc. | Mar 23, 2005 | SESE |
| K032677 | SYSMEX POCH-100I | Sysmex America, Inc. | Feb 11, 2004 | SESE |
| K022331 | ADVIA 120 HEMATOLOGY SYSTEM, CEREBROSPINAL FLUID METHOD | Bayer Diagnostics Corp. | Sep 11, 2002 | SESE |
| K001683 | SYSMEX R-500 | Sysmex Corporation of America | Aug 21, 2000 | SESE |
| K991070 | COULTER Z2 ANALYZER | Coulter Corp. | May 11, 1999 | SESE |
| K981950 | SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500 | Sysmex Corp. | Nov 3, 1998 | SESE |
| K981761 | SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER | Sysmex Corp. | Aug 14, 1998 | SESE |
| K971998 | ADVIA 120 HEMATOLOGY SYSTEM, IN VITRO DIAGNOSTIC SYSTEM | Bayer Corp. | Aug 29, 1997 | SESE |
| K964375 | SYSMEX SE/RAM-1 | Sysmex Corp. | Mar 13, 1997 | SESE |
| K962988 | COULTER GEN-S SYSTEM | Coulter Corp. | Oct 30, 1996 | SESE |
| K954607 | RETICULOCYTE METHOD | Bayer Corp. | Aug 30, 1996 | SESE |
| K954006 | YELLOW IRIS URINALYSIS WORKSTATION W/IRISCOPE BODY FLUID ANALYSIS CAPABILITY | Intl. Remote Imaging Systems | Mar 12, 1996 | SESE |
| K952308 | COULTER Z 1 | Coulter Corp. | Oct 6, 1995 | SESE |
| K934539 | THE YELLOW IRIS URINALYSIS WORKSTATION WITH IRISCOPE BODY FLUID ANALYSIS CAPABILITY | Intl. Remote Imaging Systems | Mar 30, 1994 | SESE |
| K930685 | TECHNICON H* 3TM RTC SYSTEM (IN-VITRO DIAG.SYST.) | Heraeus Kulzer, Inc. | Jun 22, 1993 | SESE |
| K923121 | QBC HEMACAN HEMATOLOGY SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | Sep 22, 1992 | SESE |
Top Applicants
- Coulter Electronics, Inc. — 17 clearances
- Toa Medical Electronics USA, Inc. — 15 clearances
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 11 clearances
- Technicon Instruments Corp. — 8 clearances
- Abbott Diagnostics — 7 clearances
