Counter, Cell, Automated (Particle Counter)
FDA product code GKL · Class II (moderate risk) · 21 CFR 864.5200 · Hematology
130510(k) clearances
0PMA approvals
6recalls
Manufacturers
- Coulter Electronics, Inc. 17
- Toa Medical Electronics USA, Inc. 15
- Bd Becton Dickinson Vacutainer Systems Preanalytic 11
- Technicon Instruments Corp. 8
- Abbott Diagnostics 7
- Diagnostic Technology, Inc. 5
- Hycel, Inc. 5
- Instrumentation Laboratory CO 4
- Sysmex Corp. 4
- Coulter Corp. 3
- Ortho Instruments 3
- Intl. Remote Imaging Systems 3
- Contraves Medical Instruments, Inc. 2
- J.T. Baker Chemical Co. 2
- Hamilton Thorne Research 2
- Future Impex Corp. 2
- Baker Instructions Corp. 2
- Mallinckrodt Critical Care 2
- Texas Intl. Laboratories, Inc. 2
- Seragen Diagnostics, Inc. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K152776 | Glocyte Automated Cell Counter SystemGKL · Traditional | Advanced Instruments, Inc. | 05/27/2016SE |
| K091539 | Iq 200 Urine Analizer Body Fluids ModuleGKL · Traditional | Iris Diagnostics | 08/31/2010SE |
| K071652 | Hemocue WBC SystemGKL · Traditional | Hemocue AB | 10/25/2007SE |
| K051693 | Modification to Bayer Advia 2120 Hematology Analyzer with Autoslide SystemGKL · Traditional | Bayer Healthcare, LLC | 12/07/2005SE |
| K050235 | Iq 200 Urine Analyzer Body Fluids ModuleGKL · Traditional | Iris International, Inc. | 03/23/2005SE |
| K032677 | Sysmex POCH-100IGKL · Traditional | Sysmex America, Inc. | 02/11/2004SE |
| K022331 | Advia 120 Hematology System, Cerebrospinal Fluid MethodGKL · Special | Bayer Diagnostics Corp. | 09/11/2002SE |
| K001683 | Sysmex R-500GKL · Traditional | Sysmex Corporation of America | 08/21/2000SE |
| K991070 | Coulter Z2 AnalyzerGKL · Traditional | Coulter Corp. | 05/11/1999SE |
| K981950 | Sysmex R-3500, Automated Reticculocyte Analyzer, Model R-3500GKL · Traditional | Sysmex Corp. | 11/03/1998SE |
| K981761 | Sysmex KX-21, Automated Hematology AnalyzerGKL · Traditional | Sysmex Corp. | 08/14/1998SE |
| K971998 | Advia 120 Hematology System, in Vitro Diagnostic SystemGKL · Traditional | Bayer Corp. | 08/29/1997SE |
| K964375 | Sysmex SE/RAM-1GKL · Traditional | Sysmex Corp. | 03/13/1997SE |
| K962988 | Coulter Gen-S SystemGKL · Traditional | Coulter Corp. | 10/30/1996SE |
| K954607 | Reticulocyte MethodGKL · Traditional | Bayer Corp. | 08/30/1996SE |
| K954006 | Yellow Iris Urinalysis Workstation W/Iriscope Body Fluid Analysis CapabilityGKL · Traditional | Intl. Remote Imaging Systems | 03/12/1996SE |
| K952308 | Coulter Z 1GKL · Traditional | Coulter Corp. | 10/06/1995SE |
| K934539 | The Yellow Iris Urinalysis Workstation with Iriscope Body Fluid Analysis CapabilityGKL · Traditional | Intl. Remote Imaging Systems | 03/30/1994SE |
| K930685 | Technicon H* 3TM RTC System (In-Vitro Diag.Syst.)GKL · Traditional | Heraeus Kulzer, Inc. | 06/22/1993SE |
| K923121 | QBC Hemacan Hematology SystemGKL · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 09/22/1992SE |
| K920719 | Ivos AnalyzerGKL · Traditional | Hamilton Thorne Research | 06/29/1992SE |
| K914256 | Yellow Iris Urinalysis Wrksta W/Iriscope Bdy FluGKL · Traditional | Intl. Remote Imaging Systems | 05/01/1992SE |
| K912494 | Sysmex(Tm) R-3000 Automated Reticulocyte AnalyzerGKL · Traditional | Toa Medical Electronics USA, Inc. | 09/10/1991SE |
| K911173 | Sysmex F-310GKL · Traditional | Toa Medical Electronics USA, Inc. | 07/26/1991SE |
| K911172 | Sysmex F-610GKL · Traditional | Toa Medical Electronics USA, Inc. | 07/26/1991SE |
| K910849 | Sysmex F-810GKL · Traditional | Toa Medical Electronics USA, Inc. | 07/26/1991SE |
| K910679 | Genesis I Automated Cell CounterGKL · Traditional | Alicia Diagnostics, Inc. | 05/07/1991SE |
| K894539 | Sysmex R-1000 Automated Reticulocyte AnalyzerGKL · Traditional | Toa Medical Electronics USA, Inc. | 09/26/1989SE |
| K885332 | Coulter Flow Reticulocyte ReagentGKL · Traditional | Coulter Electronics, Inc. | 02/22/1989SE |
| K884618 | Nova Celltrak 11 Auto. Hema. Analyzer, CalibratorsGKL · Traditional | Nova Biomedical Corp. | 01/24/1989SE |
| K885132 | Facsmate Sample Handling DeviceGKL · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 12/28/1988SE |
| K884471 | KVM Blood Cell CounterGKL · Traditional | Kvm Instruments, Inc. | 12/27/1988SE |
| K880636 | Reticcount SoftwareGKL · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 03/21/1988SE |
| K874320 | Cellect Labtrak SoftwareGKL · Traditional | Instrumentation Laboratory CO | 01/27/1988SE |
| K872145 | Cellsoft(Tm)-Casa (Series 1000,2000 & 3000)GKL · Traditional | Cryo Corp. | 11/13/1987SE |
| K873271 | Digicell 300 SystemGKL · Traditional | Contraves Medical Instruments, Inc. | 11/06/1987SE |
| K873252 | Digicell 500GKL · Traditional | Contraves Medical Instruments, Inc. | 11/06/1987SE |
| K873172 | Hamilton-Thorn Motility Analyzer HTM-2000GKL · Traditional | Hamilton Thorne Research | 11/06/1987SE |
| K872166 | Facscan Flow Cytometer - Reticcount Reti. Enu. KitGKL · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 09/30/1987SE |
| K871830 | Napsac(Tm)GKL · Traditional | Beecher Medical Diagnostic Instrumentation | 09/09/1987SE |
| K873103 | Technicon H*1 Jr.(Tm) SystemGKL · Traditional | Technicon Instruments Corp. | 08/28/1987SE |
| K870603 | System 9000 Automated Cell CounterGKL · Traditional | Baker Instructions Corp. | 03/31/1987SE |
| K863332 | Atac 4300 Hematology Cell CounterGKL · Traditional | Turpen Laboratory Systems, Inc. | 09/29/1986SE |
| K863291 | Il Cellect 8GKL · Traditional | Instrumentation Laboratory CO | 09/04/1986SE |
| K863290 | Il Cellect 7GKL · Traditional | Instrumentation Laboratory CO | 09/04/1986SE |
| K863085 | Coulter Counter Model T-540GKL · Traditional | Coulter Electronics, Inc. | 09/04/1986SE |
| K863084 | Coulter Counter Model T-890GKL · Traditional | Coulter Electronics, Inc. | 09/04/1986SE |
| K862374 | Cellect 8E Automated Blood Cell CountersGKL · Traditional | Instrumentation Laboratory CO | 09/04/1986SE |
| K861780 | Coulter Counter Model S Plus JuniorGKL · Traditional | Coulter Electronics, Inc. | 08/06/1986SE |
| K860586 | PHA-2 Conversion Program for Platelet AnalysisGKL · Traditional | Diagnostic Technology, Inc. | 05/07/1986SE |
| K860166 | Picoscale Blood Cell Counter, Model PS-5GKL · Traditional | Diagnostic Technology, Inc. | 04/04/1986SE |
| K854678 | Erma PC-602 PC-603 Blood Cell CounterGKL · Traditional | Future Impex Corp. | 02/24/1986SE |
| K854677 | Erma PC-604 Blood Cell CounterGKL · Traditional | Future Impex Corp. | 02/24/1986SE |
| K853030 | Technicon H*1 System (HDW)GKL · Traditional | Technicon Instruments Corp. | 02/05/1986SE |
| K853722 | PLT-4 Platelet AnalyzerGKL · Traditional | Texas Intl. Laboratories, Inc. | 01/17/1986SE |
| K854114 | Coulter Counter Model T-660GKL · Traditional | Coulter Electronics, Inc. | 11/05/1985SE |
| K853036 | Picoscale Laborscale, #PSL-1 & Analyser, #PSA-1GKL · Traditional | Diagnostic Technology, Inc. | 11/05/1985SE |
| K853429 | Coulter Counter Model M5GKL · Traditional | Coulter Electronics, Inc. | 10/10/1985SE |
| K851943 | Coulter Volume AdapterGKL · Traditional | Coulter Electronics, Inc. | 08/30/1985SE |
| K851736 | Coulter Channelyzer 256GKL · Traditional | Coulter Electronics, Inc. | 07/30/1985SE |
| K850171 | Sysmex E-3000, Fully Automated Hematology SysGKL · Traditional | Toa Medical Electronics USA, Inc. | 05/13/1985SE |
| K850386 | System 8000 Cell CounterGKL · Traditional | Baker Instructions Corp. | 05/02/1985SE |
| K845019 | Cell-Dyn 1000 Automated Hematology AnalyzerGKL · Traditional | Abbott Diagnostics | 03/26/1985SE |
| K841803 | A1 Systeme 8201/2GKL · Traditional | Med USA | 02/25/1985SE |
| K843303 | Coulter Counter Model M4GKL · Traditional | Coulter Electronics, Inc. | 12/05/1984SE |
| K843164 | Coulter Counter Model ZMGKL · Traditional | Coulter Electronics, Inc. | 11/13/1984SE |
| K844042 | Blood Dilution VialGKL · Traditional | American Scientific Products | 10/23/1984SE |
| K842140 | Picoscal Blood Cell Counter PS-4GKL · Traditional | Diagnostic Technology, Inc. | 08/16/1984SE |
| K842346 | Coulter Automatic Sample HandlerGKL · Traditional | Coulter Electronics, Inc. | 07/27/1984SE |
| K840649 | Danam Elec. SA-1000GKL · Traditional | Danam Electronics | 07/19/1984SE |
| K841504 | Quick-Count Plus 2GKL · Traditional | Seragen Diagnostics, Inc. | 06/11/1984SE |
| K840658 | QBC Centrifugal Hematology AnalyzGKL · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 04/17/1984SE |
| K840170 | Cell-Dyn 100 Whole Blood PlateletGKL · Traditional | Abbott Diagnostics | 03/02/1984SE |
| K834568 | Coulter Counter M2GKL · Traditional | Coulter Electronics, Inc. | 02/10/1984SE |
| K834372 | PHA-1 Programmable Hematology AnalyzGKL · Traditional | Diagnostic Technology, Inc. | 02/10/1984SE |
| K834026 | RDW Parameter for the Technicon H6000GKL · Traditional | Technicon Instruments Corp. | 01/30/1984SE |
| K833971 | Quick-CountGKL · Traditional | Seragen Diagnostics, Inc. | 01/30/1984SE |
| K832890 | Hemacomp 7 or Hematil 7GKL · Traditional | Texas Intl. Laboratories, Inc. | 10/19/1983SE |
| K832643 | Cell-Dyn 900 Hematology AnalyzerGKL · Traditional | Abbott Diagnostics | 09/26/1983SE |
| K832627 | Technicon H6000 SystemGKL · Traditional | Technicon Instruments Corp. | 09/12/1983SE |
| K832420 | Facs AnalyzerGKL · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 09/01/1983SE |
| K832038 | Cell-Dyn 300 Hematology AnalyzerGKL · Traditional | Abbott Diagnostics | 07/18/1983SE |
| K831368 | Cell-Dyn 400 Hemotology AnalyzerGKL · Traditional | Abbott Diagnostics | 07/18/1983SE |
| K830507 | Sysmex CC-170GKL · Traditional | Toa Medical Electronics USA, Inc. | 05/13/1983SE |
| K830508 | Sysmex CC-180GKL · Traditional | Toa Medical Electronics USA, Inc. | 05/09/1983SE |
| K830506 | Sysmex CC-150GKL · Traditional | Toa Medical Electronics USA, Inc. | 05/09/1983SE |
| K830505 | Sysmex CC-130GKL · Traditional | Toa Medical Electronics USA, Inc. | 05/09/1983SE |
| K830451 | QBC Centrifugal Hematology SysGKL · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 04/27/1983SE |
| K823886 | Profile 750 Blood Cell CounterGKL · Traditional | Mallinckrodt Critical Care | 03/01/1983SE |
| K823344 | Hematology AnalyzerGKL · Traditional | Abbott Diagnostics | 12/28/1982SE |
| K822758 | Sysmex PDA-410 (Particle Distrib. AnalyGKL · Traditional | Toa Medical Electronics USA, Inc. | 10/18/1982SE |
| K821575 | Sysmex CC-800GKL · Traditional | Sysmex/Toa Medical Electronics, Inc. | 07/02/1982SE |
| K821238 | CC-700 Seven Parameter, Automated HemaaGKL · Traditional | Dysmex | 05/28/1982SE |
| K812031 | LPC IIGKL · Traditional | Labtronix Corp. | 08/12/1981SE |
| K811978 | Technicon H6000 (90/HR) Hematology SysGKL · Traditional | Technicon Instruments Corp. | 08/12/1981SE |
| K803071 | Pla-MateGKL · Traditional | Labex, Inc. | 07/24/1981SE |
| K803218 | Cell Dyn 800 Hematology AnalyzerGKL · Traditional | Abbott Diagnostics | 06/09/1981SE |
| K803128 | Series 810 Platelet AnalyzerGKL · Traditional | J.T. Baker Chemical Co. | 04/03/1981SE |
| K802636 | Platelet Counting KitGKL · Traditional | Streck Laboratories, Inc. | 12/11/1980SE |
| K802094 | Ortho SpectrumGKL · Traditional | Ortho Instruments | 10/10/1980SE |
| K802208 | Leukocyte Vol. Analysis ApparatusGKL · Traditional | Coulter Electronics, Inc. | 09/17/1980SE |
| K801545 | Ortho Automated Cell CounterGKL · Traditional | Ortho Instruments | 09/09/1980SE |
| K801155 | Technicon H6000 Hematology SystemGKL · Traditional | Technicon Instruments Corp. | 06/09/1980SE |
| K800346 | HemosafeGKL · Traditional | Med Lab Systems, Inc. | 04/16/1980SE |
| K792668 | Coulter Counter-Blood Cell CounterGKL · Traditional | Coulter Electronics, Inc. | 01/29/1980SE |
| K792537 | Coulter Counter Model S PlusGKL · Traditional | Coulter Electronics, Inc. | 01/29/1980SE |
| K791867 | Royco Model 921 Cell CounterGKL · Traditional | Royco Instruments | 11/05/1979SE |
| K790026 | Analyzer, Model CC-720GKL · Traditional | Sysmex Corp. | 02/08/1979SE |
| K782102 | Hycel Counter 211GKL · Traditional | Hycel, Inc. | 01/03/1979SE |
| K782101 | Hycel Counter 222GKL · Traditional | Hycel, Inc. | 01/03/1979SE |
| K782100 | Hycel Counter 333GKL · Traditional | Hycel, Inc. | 01/03/1979SE |
| K781562 | HemacheckGKL · Traditional | Vickers America Medical Corp. | 11/15/1978SE |
| K781628 | Hemo-W SystemGKL · Traditional | Coulter Electronics, Inc. | 10/27/1978SE |
| K781146 | Hemac Laser Hematology SystemGKL · Traditional | Ortho Instruments | 09/14/1978SE |
| K780911 | Sysmex Platelet Counter, PL-110GKL · Traditional | Toa Medical Electronics USA, Inc. | 06/28/1978SE |
| K780910 | System Auto. Blood Cell Counter CC-110GKL · Traditional | Toa Medical Electronics USA, Inc. | 06/28/1978SE |
| K780909 | Sysmex Auto. Blood Cell Counter, CC-120GKL · Traditional | Toa Medical Electronics USA, Inc. | 06/28/1978SE |
| K780224 | Microcell Counter Model CC-108GKL · Traditional | Toa Medical Electronics USA, Inc. | 05/19/1978SE |
| K771512 | Counter Model S Plus Blood Cell CounterGKL · Traditional | Coulter Electronics, Inc. | 11/09/1977SE |
| K771728 | Auto. Leucocyte Differ. Analyzer D/90GKL · Traditional | Technicon Instruments Corp. | 11/07/1977SE |
| K771790 | Detectoterge Azide FreeGKL · Traditional | J.T. Baker Chemical Co. | 10/07/1977SE |
| K771353 | Platelet Counter & Hematocrit Acces.GKL · Traditional | Hycel, Inc. | 08/10/1977SE |
| K771107 | Counter 700 & HC-700 Hemo 0 Ref.GKL · Traditional | Hycel, Inc. | 07/11/1977SE |
| K770666 | Hemalog 8/90GKL · Traditional | Technicon Instruments Corp. | 05/06/1977SE |
| K770385 | Latelet Determin. Kit, Cat No. 2521GKL · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 04/08/1977SE |
| K761289 | Ultra Logic 800 Hematology Ana. (UL-800)GKL · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 03/28/1977SE |
| K770034 | Counter, Blood Cell & HematocritGKL · Traditional | Mallinckrodt Critical Care | 02/16/1977SE |
| K760765 | Whole Blood Platelet Counter -2510GKL · Traditional | Clay Adams, Div. Becton Dickinson & Co. | 12/30/1976SE |
| K760582 | HA/3 Hematology AnalyzerGKL · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 11/11/1976SE |
| K760581 | HA/5 Hematology AnalyzerGKL · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 11/09/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0640-2019 Class II | GloCyte RBC Reagent - Product Usage: The GloCyte Automated Cell Counter System is…RBC Reagent failure. High fluorescent counts during RBC Reagent + Diluent QC check that will result in… | Advanced Instruments, LLC | 02/07/2018Terminated |
| Z-1390-2016 Class III | BD-Retic-Count Reticulocyte Reagent System; Hematology: Used for in vitro diagnosticsThe carton label for one lot of BD Retic-Count Reticulocyte Reagent System had the incorrect storage… | Becton, Dickinson and Company, BD Biosciences | 03/18/2016Terminated |
| Z-1000-2015 Class II | CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046. Hematology: Single color…One lot of CD8 PE is contaminated with CD4 FITC and may cause an unexpected staining pattern and incorrect… | BD Biosciences, Systems & Reagents | 12/19/2014Terminated |
| Z-2114-2013 Class II | ADVIA 120 Hematology Analyzer, Catalog Numbers SMN 10360958 and 10360959 . The ADVIA 120…The ADVIA 120 optics cover or hood is located on the very top of the ADVIA 120 analyzer. When the optics… | Siemens Healthcare Diagnostics | 06/26/2013Terminated |
| Z-1956-2011 | Coulter GEN's The COULTER LH 500 Analyzer is a quantitative, automated hematology…This recall was initiated because Beckman Coulter identified a problem with some date fields that are… | Beckman Coulter Inc. | 01/31/2011Terminated |
| Z-0315-2008 | COULTER GEN*S System, Part Number: 6605381, Beckman Coulter, Brea, CA. (Hematology…Patient Mis-identification can occur: 1)- When a positive identifier (Sample ID or Cassette/Position) is… | Beckman Coulter Inc | 04/18/2007Terminated |