Fluorometer, For Clinical Use
FDA product code KHO · Class I (low risk) · 21 CFR 862.2560 · Clinical Chemistry
38510(k) clearances
0PMA approvals
31recalls
Manufacturers
- The Perkin-Elmer Corp. 5
- Abbott Laboratories 2
- Tosoh Corp. 2
- Lkb Instruments, Inc. 2
- Pb Diagnostic Systems, Inc. 2
- Baxter Healthcare Corp 2
- Miles Laboratories, Inc. 2
- Dynatech Corp. 1
- Radiometer Medical Aps 1
- Dynatech Laboratories, Inc. 1
- Pharmacia, Inc. 1
- Cyberfluor, Inc. 1
- Helena Laboratories 1
- Abbott Diagnostics 1
- Innotron of Oregon, Inc. 1
- American Diagnostic Corp. 1
- Syva Co. 1
- Bio-Rad 1
- Varian Assoc., Inc. 1
- Waters Assoc., Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K112161 | AQT90 Flex Analyzer, AQT90 Flex Myoglobin Test Kit, AQT90 Flex LQC Multi-Check, LVLS…KHO · Traditional | Radiometer Medical Aps | 01/20/2012SE |
| K973547 | Triage StatmeterKHO · Traditional | Biosite Incorporated | 01/13/1998SE |
| K971103 | Aia Nexia-Automated Enzyme Immunoassay SystemKHO · Traditional | Tosoh Medics, Inc. | 06/27/1997SE |
| K962919 | Vitros Immunodiagnostic SystemKHO · Traditional | Johnson & Johnson Clinical Diagnostics, Inc. | 10/18/1996SE |
| K952719 | Biocircuits Ios (In-Office System)KHO · Traditional | Biocircuits Corp. | 11/22/1995SE |
| K950415 | Fluoroscan NeonatalKHO · Traditional | Isolab, Inc. | 09/05/1995SE |
| K935047 | Auto DelfiaKHO · Traditional | Wallac OY | 05/23/1994SE |
| K930689 | Autobead Thyroid UptakeKHO · Traditional | Bio-Chem Laboratory Systems, Inc. | 11/10/1993SE |
| K926131 | Opus Magnum AnalyzerKHO · Traditional | Pb Diagnostic Systems, Inc. | 06/07/1993SE |
| K923021 | AIA-1200DX - Automated Enzyme Immunoassay SystemKHO · Traditional | Tosoh Corp. | 07/21/1992SE |
| K920888 | Microlite Microtiter Plate Luminometer ML2200KHO · Traditional | Dynatech Laboratories, Inc. | 03/19/1992SE |
| K913130 | Stratus Iintellect Immunoassay SystemKHO · Traditional | Baxter Healthcare Corp | 09/27/1991SE |
| K901674 | AIA-600 Automated Enzyme Immunoassay SystemKHO · Traditional | Tosoh Corp. | 05/02/1990SE |
| K895240 | Delfia Plate Fluorometer 1232KHO · Traditional | Pharmacia, Inc. | 10/04/1989SE |
| K894159 | Opus Immunoassay SystemKHO · Traditional | Pb Diagnostic Systems, Inc. | 08/03/1989SE |
| K890908 | Stratus(R) II Fluorometric Analyzer & AccessoriesKHO · Traditional | Baxter Healthcare Corp | 03/24/1989SE |
| K872803 | Cyberfluor 615 ImmunoanalyzerKHO · Traditional | Cyberfluor, Inc. | 09/02/1987SE |
| K871550 | PFI-20 Polarizing FluorimeterKHO · Traditional | The Perkin-Elmer Corp. | 07/01/1987SE |
| K860309 | Hemafluor Reagent KitKHO · Traditional | Helena Laboratories | 07/14/1986SE |
| K851984 | Lkb-Wallac 1230 Arcus FluorometerKHO · Traditional | Lkb Instruments, Inc. | 05/24/1985SE |
| K830624 | Fluorometer, General UseKHO · Traditional | Abbott Diagnostics | 04/05/1983SE |
| K822942 | Innotron Fluorimeter Series ONE-10KHO · Traditional | Innotron of Oregon, Inc. | 12/09/1982SE |
| K823112 | Clinistat Tda SeriesKHO · Traditional | Miles Laboratories, Inc. | 11/29/1982SE |
| K822772 | Microfluor ReaderKHO · Traditional | Dynatech Corp. | 10/27/1982SE |
| K822701 | Fluorostat FluorometerKHO · Traditional | Miles Laboratories, Inc. | 10/08/1982SE |
| K813540 | A FluorometerKHO · Traditional | American Diagnostic Corp. | 12/31/1981SE |
| K813146 | Syva Advance TM FluorometerKHO · Traditional | Syva Co. | 11/27/1981SE |
| K811019 | LKB 4460 FluorimeterKHO · Traditional | Lkb Instruments, Inc. | 04/29/1981SE |
| K802579 | Cybrex TM FPQ Fluorescene PolarizationKHO · Traditional | Abbott Laboratories | 11/12/1980SE |
| K791329 | Fluoromatic Analyzer and AutosamplerKHO · Traditional | Bio-Rad | 07/30/1979SE |
| K790236 | Spectrophotometer Model 650-40KHO · Traditional | The Perkin-Elmer Corp. | 03/15/1979SE |
| K790235 | Spectrophotometer Model 3000KHO · Traditional | The Perkin-Elmer Corp. | 03/15/1979SE |
| K780242 | Spectrophotometer, Fluorescence M.650-10KHO · Traditional | The Perkin-Elmer Corp. | 03/27/1978SE |
| K780362 | Spectrofluorometer SF-330KHO · Traditional | Varian Assoc., Inc. | 03/22/1978SE |
| K780122 | HTSH RiaKHO · Traditional | Abbott Laboratories | 02/03/1978SE |
| K780031 | Fluorescence Detector Model 420KHO · Traditional | Waters Assoc., Inc. | 01/20/1978SE |
| K760506 | Hemaflour ZPKHO · Traditional | Buchler Instruments, Inc. | 10/28/1976SE |
| K760261 | Detector, Model LC-100 FluorescenceKHO · Traditional | The Perkin-Elmer Corp. | 09/27/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2423-2020 Class II | AIA-900 Analyzer, Part no. 022930, UDI 04560189283992The Substrate Monitoring System in the AIA-900 Analyzer did not detect an empty substrate bottle. The issue… | Tosoh Bioscience Inc | 05/22/2020Terminated |
| Z-1420-2020 Class II | AIA-360 Automated Immunoassay Analyzer, Product Code 019945A display screen software issue on the analyzer causes the display to freeze when display screen is touched… | Tosoh Bioscience Inc | 01/10/2020Terminated |
| Z-1293-2019 Class II | VITROS ECi Immunodiagnostic System Refurbished Product Code: 6801059 For use in the in…Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS Systems | Ortho-Clinical Diagnostics | 02/20/2019Terminated |
| Z-1292-2019 Class II | VITROS ECi/ECiQ Immunodiagnostic System Product Code: 1922814 For use in the in vitro…Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS Systems | Ortho-Clinical Diagnostics | 02/20/2019Terminated |
| Z-0509-2019 Class II | AIA-900 Automated Immunoassay Analyzer, product code 022930 /022930R Product Usage: The…Tosoh Bioscience has become aware of a potential issue with the axis base of the turntable rotation drive… | Tosoh Bioscience Inc | 10/05/2018Terminated |
| Z-0469-2019 Class II | AIA-900 Analyzer, Product code 022930, 022930RTosoh Bioscience has become aware of a potential issue with the pickup arm and pickup arm motor on the… | Tosoh Bioscience Inc | 10/05/2018Terminated |
| Z-0600-2019 Class II | AIA-900Analyzer, Product code 022930, 022930R The AIA-2000 analyzer and AIA-900 analyzer…Tosoh Bioscience has become aware of a potential issue with the AIA-900 and AIA-2000 analyzers that could… | Tosoh Bioscience Inc | 09/28/2018Terminated |
| Z-0599-2019 Class II | AIA-2000 Analyzer, Product code 022100, 022100R, 022101, 022101R The AIA-2000 analyzer…Tosoh Bioscience has become aware of a potential issue with the AIA-900 and AIA-2000 analyzers that could… | Tosoh Bioscience Inc | 09/28/2018Terminated |
| Z-0485-2019 Class II | Tosoh AIA-900 immunoassay AnalyzerA software issue may cause the liquid volume detection entries for 2nd and 3rd reagent bottles to be… | Tosoh Bioscience Inc | 09/28/2018Terminated |
| Z-0475-2019 Class II | AIA-2000 Analyzer, Model Nos. AIA-2000LA, AIA-2000ST - Product Usage: The AIA-2000 is…There is a possibility that the liquid suction pump on some AIA-2000 analyzers may not perform as intended… | Tosoh Bioscience Inc | 09/28/2018Terminated |
| Z-0559-2019 Class II | AIA-360 Analyzer, product code 019945/019945R The Tosoh AIA-360 Automated Immunoassay…The firm has implemented new product labeling changes for the Tosoh AIA-360 Analyzer. These labeling changes… | Tosoh Bioscience Inc | 08/23/2018Terminated |
| Z-0602-2019 Class II | AIA-900 Automated Immunoassay Analyzer performs three methods of immunoassay: an…The firm has become aware of a potential issue that may affect the mixing motor drive harness and mixing… | Tosoh Bioscience Inc | 09/28/2017Terminated |
| Z-0492-2018 Class II | TosohSorter 9tray, Product Code 022931and TosohSorter 19tray, Product Code 022932.…This recall has been initiated due to a potential malfunction of the photo interrupter (Pl). The potential… | Tosoh Bioscience Inc | 06/11/2017Terminated |
| Z-0491-2018 Class II | TosohAutomated Enzyme Immunoassay Analyzer AIA-900, Product Catalog No. 022930. Product…This recall has been initiated due to a potential malfunction of the photo interrupter (Pl). The potential… | Tosoh Bioscience Inc | 06/11/2017Terminated |
| Z-0613-2019 Class II | AIA-360 Analyzer is capable of performing two methods of immunoassay: an…The firm has become aware of a potential issue with the AIA-360 analyzer that could prevent the table home… | Tosoh Bioscience Inc | 03/22/2017Terminated |
| Z-1108-2017 Class II | Spare Disk Remover Module; Product Number: 61001820 Intended for in vitro quantitative…The firm became aware that the ball bushing axels are defective in the GSP instrument. During exposure to… | PerkinElmer Life and Analytical Sciences… | 01/05/2017Terminated |
| Z-1107-2017 Class II | Genetic Screening Processor (GSP); PerkinElmer Part Number= 2021-0010 Intended for in…The firm became aware that the ball bushing axels are defective in the GSP instrument. During exposure to… | PerkinElmer Life and Analytical Sciences… | 01/05/2017Terminated |
| Z-1102-2017 Class III | DELFIA PC with V3.0 Software, Fluorometer, for clinical use Product Number: 1235-8100…AutoDELFIA System with Version 3.0 Software: Potential plate loading failures | PerkinElmer Health Sciences, Inc. | 12/21/2016Terminated |
| Z-1101-2017 Class III | Program Update Package AutoDELFIA 3.0, Fluorometer, for clinical use Product Number:…AutoDELFIA System with Version 3.0 Software: Potential plate loading failures | PerkinElmer Health Sciences, Inc. | 12/21/2016Terminated |
| Z-1100-2017 Class III | AutoDELFIA Plate Processor , Fluorometer, for clinical use Product Number: 1235-5110…AutoDELFIA System with Version 3.0 Software: Potential plate loading failures | PerkinElmer Health Sciences, Inc. | 12/21/2016Terminated |
| Z-1971-2015 Class II | Infinite 200 in vitro diagnostic. Product Usage: The Tecan Infinite 200 is a…A firmware bug causes incorrect values to be displayed for specific measured luminescence values. | Tecan US, Inc. | 05/29/2015Terminated |
| Z-1970-2015 Class II | Infinite 200 PRO in vitro diagnostic. Product Usage: The Tecan Infinite 200 PRO is a…A firmware bug causes incorrect values to be displayed for specific measured luminescence values. | Tecan US, Inc. | 05/29/2015Terminated |
| Z-1969-2015 Class II | Infinite M1000 in vitro diagnostic. Product Usage: The Tecan Infinite M1000 is a…A firmware bug causes incorrect values to be displayed for specific measured luminescence values. | Tecan US, Inc. | 05/29/2015Terminated |
| Z-1968-2015 Class II | Infinite M1000 PRO in vitro diagnostic. Product Usage: The Tecan Infinite M1000 PRO is a…A firmware bug causes incorrect values to be displayed for specific measured luminescence values. | Tecan US, Inc. | 05/29/2015Terminated |
| Z-1967-2015 Class II | Infinite F500, in vitro diagnostic. Product Usage: The Tecan Infinite F500 is a…A firmware bug causes incorrect values to be displayed for specific measured luminescence values. | Tecan US, Inc. | 05/29/2015Terminated |
| Z-0992-2015 Class III | Infinite 200PRO The Tecan Infinite 200 is a multifunctional microplate reader with…Incorrect lumi firmware version installed (E.027 instead of V2.00) | Tecan US, Inc. | 11/10/2014Terminated |
| Z-0991-2015 Class III | Infinite 200 The Tecan Infinite 200 is a multifunctional microplate reader with injector…Incorrect lumi firmware version installed (E.027 instead of V2.00) | Tecan US, Inc. | 11/10/2014Terminated |
| Z-1830-2013 Class II | AIA Analyzer Pipette Tips used on Tosoh AIA-2000, AIA-1800, AIA-900 and AIA-600II…Visual inspection of the pipette tips indicated that some of the tips were not uniform in size/length which… | Tosoh Smd Inc | 05/15/2013Terminated |
| Z-1116-2012 | Perkin Elmer Genetic Screening Processor (GSP) Product code: 2021-0010. It is intended…GSP instruments with defective washer modules may cause a false negative screening result being reported for… | PerkinElmer Life and Analytical Sciences… | 01/09/2012Terminated |
| Z-0924-2012 | VITROS ECiQ Immunodiagnostic System, Catalog No. 1922814 --- COMMON/USUAL NAME: VITROS…Software defect; Ortho Clinical Diagnostics received complaints of observed results from diluted samples… | Ortho-Clinical Diagnostics | 08/24/2011Terminated |
| Z-0923-2012 | VITROS ECi Immunodiagnostic System, Catalog No. 8633893 --- COMMON/USUAL NAME: VITROS…Software defect; Ortho Clinical Diagnostics received complaints of observed results from diluted samples… | Ortho-Clinical Diagnostics | 08/24/2011Terminated |