Analyzer, Chemistry, Micro, For Clinical Use
FDA product code JJF · Class I (low risk) · 21 CFR 862.2170 · Clinical Chemistry
57510(k) clearances
0PMA approvals
9recalls
Manufacturers
- Technicon Instruments Corp. 3
- Syva Co. 3
- Kone Instruments, Inc. 3
- Beckman Instruments, Inc. 3
- Olympus Corp. 2
- Roche Molecular Systems, Inc. 2
- Hi Chem, Inc. 2
- Instrumentation Laboratory CO 2
- Lkb Instruments, Inc. 2
- Alpkem Corp. 2
- Nova Biomedical Corp. 2
- Associated Electro-Medical Services, Inc. 2
- Macomb Chemical Co. 1
- Coulter Electronics, Inc. 1
- Roche Diagnostic Systems, Inc. 1
- Bd Becton Dickinson Vacutainer Systems Preanalytic 1
- DiaSorin, Inc. 1
- Medico Electronic, Inc. 1
- Gilford Instrument Laboratories, Inc. 1
- Pm America, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K052794 | Eti-Max 3000JJF · Traditional | DiaSorin, Inc. | 03/31/2006SE |
| K040332 | Polymedco Spotchem Ez Chemistry AnalyzerJJF · Traditional | Arkray, Inc. | 06/16/2004SE |
| K033734 | Lightcycler Instrument Version 1.2JJF · Traditional | Roche Diagnostics Corp. | 12/17/2003SE |
| K013654 | Precision Systems Analette Chemistry AnalyzerJJF · Traditional | Precision Systems, Inc. | 06/05/2002SE |
| K012966 | Roche Cobas Taqman AnalyzerJJF · Traditional | Roche Molecular Systems, Inc. | 02/01/2002SE |
| K993634 | Careside AnalyzerJJF · Traditional | Careside, Inc. | 12/02/1999SE |
| K973628 | Vitalab Flexor/Vitalab Selectra 2/VITALAB VivaJJF · Traditional | Vital Scientific N.V. | 03/13/1998SE |
| K980056 | Careside AnalyzerJJF · Traditional | Exigent Diagnostics, Inc. | 03/06/1998SE |
| K973177 | Mago Automated Eia ProcessorJJF · Traditional | Diamedix Corp. | 10/09/1997SE |
| K971491 | Synermed Ir 200 Chemistry AnalyzerJJF · Traditional | Synermed, Inc. | 06/26/1997SE |
| K964506 | Roche Cobas Amplicor AnalyzerJJF · Traditional | Roche Molecular Systems, Inc. | 05/21/1997SE |
| K965103 | Winmax Software SystemsJJF · Traditional | Diagnostic Products Corp. | 05/09/1997SE |
| K964409 | HCL - 200 Biochemistry AnalyzerJJF · Traditional | Hcl Laboratory Systems, Inc. | 01/22/1997SE |
| K961209 | Brio Automatic Samplinc UnitJJF · Traditional | Seac S.R.L. | 12/24/1996SE |
| K943978 | Waters Pico Tag Chem Pack/Free Amino Acid AnalysisJJF · Traditional | Waters Chromatography Division | 05/02/1995SE |
| K942676 | Synchron CX3 DeltaJJF · Traditional | Beckman-Diagnostic Systems Group | 11/02/1994SE |
| K925093 | System 6300 Series High Performance Amino Acid AnaJJF · Traditional | Beckman Instruments, Inc. | 11/16/1993SE |
| K912055 | Syva EdmsJJF · Traditional | Syva Co. | 06/10/1991SE |
| K903357 | Syva(R) Ets(R) Plus SystemJJF · Traditional | Syva Co. | 09/27/1990SE |
| K893768 | Modified PK300 Automatic Eia AnalyzerJJF · Traditional | Olympus Corp. | 08/15/1989SE |
| K883350 | Reconditioned Astra(Tm) 4JJF · Traditional | Associated Electro-Medical Services, Inc. | 03/16/1989SE |
| K883298 | Reconditioned Astra (TM) 8JJF · Traditional | Associated Electro-Medical Services, Inc. | 03/16/1989SE |
| K883020 | RFA-300 Rapid Flow Analyzer W/ComputerJJF · Traditional | Alpkem Corp. | 09/02/1988SE |
| K872120 | Seralyzer III Blood Chemistry AnalyzerJJF · Traditional | Miles Laboratories, Inc. | 10/28/1987SE |
| K871486 | (Fpia) Assay BufferJJF · Traditional | Windsor Laboratories, Inc. | 05/08/1987SE |
| K870777 | Progress Plus Selective Chemistry AnalyzerJJF · Traditional | Kone Instruments, Inc. | 03/13/1987SE |
| K863245 | Syva Ets SystemJJF · Traditional | Syva Co. | 03/13/1987SE |
| K864834 | Olympus PK300JJF · Traditional | Olympus Corp. | 02/20/1987SE |
| K864236 | Synchron CX3JJF · Traditional | Beckman Instruments, Inc. | 12/31/1986SE |
| K852385 | Hybritech Immunochemistry AnalyzerJJF · Traditional | Hybritech, Inc. | 07/12/1985SE |
| K851933 | Clinical Chemistry Analytical SystemJJF · Traditional | Allied Instrumentation Laboratory | 06/10/1985SE |
| K851542 | RFA-300 Rapid Flow Analyzer W/ComputerJJF · Traditional | Alpkem Corp. | 05/10/1985SE |
| K851172 | Cobas MiraJJF · Traditional | Roche Diagnostic Systems, Inc. | 05/02/1985SE |
| K850999 | Technicon Gen 2 Sys & Analytes LD, Alp CK, Un, inJJF · Traditional | Technicon Instruments Corp. | 04/08/1985SE |
| K844586 | Il Genesis 21, Clinical Chemistry Analytical SysJJF · Traditional | Instrumentation Laboratory CO | 12/11/1984SE |
| K840200 | Progress Selective Dhemistry AnalyzJJF · Traditional | Kone Instruments, Inc. | 04/04/1984SE |
| K833998 | Qca Chemistry AnalyzerJJF · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 01/30/1984SE |
| K833804 | Shaban 9865 IL#78637 Junction BlocJJF · Traditional | Shaban Mfg. Co. | 01/13/1984SE |
| K833154 | Nova 9 Sodium/Potassium/Total CalciumJJF · Traditional | Nova Biomedical Corp. | 12/08/1983SE |
| K833153 | Nova 10 Sodium/Potassium/Total CalciuJJF · Traditional | Nova Biomedical Corp. | 11/25/1983SE |
| K831227 | Compur Easy Touch Chemistry Analyzer-JJF · Traditional | Worthington Diagnostic Systems | 06/02/1983SE |
| K830095 | Rapid Chem Analyzer IIJJF · Traditional | Macomb Chemical Co. | 01/28/1983SE |
| K821583 | Ames/Gilford Optimate Clin. Chem & TherJJF · Traditional | Gilford Instrument Laboratories, Inc. | 06/24/1982SE |
| K820541 | MicrolyteJJF · Traditional | Kone Instruments, Inc. | 05/24/1982SE |
| K820748 | Poli-Mak Model F-4 (FinalJJF · Traditional | Pm America, Inc. | 04/06/1982SE |
| K820415 | 4150 Alpha Amino Acid AnalyzerJJF · Traditional | Lkb Instruments, Inc. | 03/11/1982SE |
| K803004 | Amino Acid Analyser SystemJJF · Traditional | Lkb Instruments, Inc. | 12/22/1980SE |
| K802398 | Electroly Te Chemistry AnalyzerJJF · Traditional | Instrumentation Laboratory CO | 10/31/1980SE |
| K802264 | Wash Solution Kit, #88102JJF · Traditional | Hi Chem, Inc. | 10/31/1980SE |
| K802392 | Astra Printer Paper #88112-CHLORIDE SilvJJF · Traditional | Hi Chem, Inc. | 10/23/1980SE |
| K790197 | Reagent Kit, Lancer GlucoseJJF · Traditional | Sherwood Medical Industries | 03/12/1979SE |
| K790335 | Hycel MJJF · Traditional | Hycel, Inc. | 02/27/1979SE |
| K781606 | MEPA-1 Blood AnalyzerJJF · Traditional | Medico Electronic, Inc. | 10/03/1978SE |
| K781442 | Beckman Astra SystemJJF · Traditional | Beckman Instruments, Inc. | 10/03/1978SE |
| K771821 | Stac SystemJJF · Traditional | Technicon Instruments Corp. | 11/07/1977SE |
| K771939 | Stac System-Addi. AnalytesJJF · Traditional | Technicon Instruments Corp. | 11/03/1977SE |
| K771513 | Kem-O-MatJJF · Traditional | Coulter Electronics, Inc. | 08/22/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0547-2020 Class II | V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180During in-house testing it was determined that their is a possibility that during a sample run, the… | Vital Scientific N.V. | 11/15/2018Open, Classified |
| Z-0038-2020 Class II | V-Twin, Catalog # 6002-800, UDI: 03661540600180 - Product Usage: An in vitro diagnostic…The action is being initiated because the cooling indicator board was improperly installed. This was first… | Vital Scientific N.V. | 09/07/2018Terminated |
| Z-2558-2019 Class II | V-Twin, Model # 6002-800, UDI: 03661540600180 Product Usage: An in-vitro diagnostic…Instrument stopped working due to a software lockup, and no patient results are produced. | Vital Scientific N.V. | 01/18/2016Open, Classified |
| Z-2209-2012 Class II | COBAS AmpliPrep Sample Tube Input Barcode Clips, catalog number 03137040001. Input…Certain lots of COBAS AmpliPrep (CAP) S-tube Input (Box of 12 bags 12x24 S-tube and 12x24 S-clip) can cause… | Roche Molecular Systems, Inc. | 02/01/2012Terminated |
| Z-0156-2020 Class II | V-Twin, Catalog # 6002-800, UDI # 03661540600180 Product Usage: automated chemistry…The action was initiated due power supply failure. During a power supply failure the instruments… | Vital Scientific N.V. | 01/10/2012Terminated |
| Z-0155-2020 Class II | Viva-E, Catalog # 6002-380, UDI # 03661540600050 Product Usage: automated chemistry…The action was initiated due power supply failure. During a power supply failure the instruments… | Vital Scientific N.V. | 01/10/2012Terminated |
| Z-0154-2020 Class II | Viva - JR, catalog # 6002-940, UDI # 03661540600210 Product Usage: automated chemistry…The action was initiated due power supply failure. During a power supply failure the instruments… | Vital Scientific N.V. | 01/10/2012Terminated |
| Z-0459-2008 | Roche Diagnostics LightCycler Capillaries (100uL) for use in conjunction with the…False Negative Results: Air bubbles in the lens or the area surrounding the lens of the LightCycler 100 uL… | Roche Diagnostics Corp. | 08/30/2007Terminated |
| Z-1106-2007 | Amplilink Software versions 1.1, 1.3, 1.4, 2.41. COBAS Amplicor CTA & NGA TestsFor select COBAS AMPLICOR Tests run on the COBAS AMPLICOR Analyzer in conjunction with AMPLILINK software, a… | Roche Molecular Systems, Inc. | 05/21/2007Terminated |