Photometric Method, Iron (Non-Heme)
FDA product code JIY · Class I (low risk) · 21 CFR 862.1410 · Clinical Chemistry
67510(k) clearances
0PMA approvals
19recalls
Manufacturers
- Em Diagnostic Systems, Inc. 7
- Data Medical Associates, Inc. 5
- Technicon Instruments Corp. 2
- Catachem, Inc. 2
- Eastman Kodak Company 2
- Dade Behring, Inc. 2
- Pointe Scientific, Inc., 2
- Olympus Corp. 2
- American Dade 2
- American Monitor Corp. 2
- Clinical Data, Inc. 2
- Diagnostic Chemicals , Ltd. 2
- Stanbio Laboratory 2
- Emd Chemicals, Inc. 1
- Gamma Enterprises, Inc. 1
- Sandare Chemical Co., Inc. 1
- Livonia Diagnostics, Inc. 1
- Anco Medical Reagents & Assoc. 1
- J. D. Assoc. 1
- The Dow Chemical Co. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K061793 | Dimension Vista Iron Flex Reagent Cartridge and CalibratorJIY · Special | Dade Behring, Inc. | 08/07/2006SE |
| K060264 | Dimension Iron Flex Reagent Cartridge (IRON-DF85)JIY · Traditional | Dade Behring, Inc. | 03/08/2006SE |
| K051115 | Sentinel Iron LiquidJIY · Traditional | Sentinel Ch. Srl | 08/25/2005SE |
| K033983 | Vitalab Iron ReagentJIY · Traditional | Clinical Data, Inc. | 05/21/2004SE |
| K030528 | Atac Iron Reagent, Atac Tibc Column Kit and Iron Calibrator (500 Ug/Dl)JIY · Traditional | Clinical Data | 06/17/2003SE |
| K020816 | Iron-Pc-Sl Assay Model # 151-10, 151-26JIY · Traditional | Diagnostic Chemicals , Ltd. | 05/14/2002SE |
| K013097 | Wiener Lab.Fer-Color Aa, Model 5X 20 ML Cat.N 1492003JIY · Traditional | Wiener Laboratories Saic | 11/13/2001SE |
| K981241 | IronJIY · Traditional | Abbott Laboratories | 05/01/1998SE |
| K973933 | Serum Iron-Sl Assay, Catalogue Numbers 157-10, 157-30JIY · Traditional | Diagnostic Chemicals , Ltd. | 11/04/1997SE |
| K972363 | Il Test IronJIY · Traditional | Instrumentation Laboratory CO | 08/15/1997SE |
| K964913 | Iron ReagentJIY · Traditional | Derma Media Lab., Inc. | 02/20/1997SE |
| K961588 | Total Iron (Nitro-Paps) Reagent SetJIY · Traditional | Pointe Scientific, Inc., | 11/18/1996SE |
| K935712 | Iron/Tibc ReagentJIY · Traditional | Horizon Diagnostics, Inc. | 09/20/1995SE |
| K944911 | Ace Iron ReagentJIY · Traditional | Schiapparelli Biosystems, Inc. | 02/10/1995SE |
| K943029 | Iron QvetJIY · Traditional | Prisma Systems | 12/02/1994SE |
| K944462 | Dma Iron ProcedureJIY · Traditional | Data Medical Associates, Inc. | 11/15/1994SE |
| K935287 | Iron -Ii (Fe-Ii) Method/Tech Chem 1(R) 1+TM SystemJIY · Traditional | Miles, Inc. | 01/03/1994SE |
| K935176 | Iron TestJIY · Traditional | Em Diagnostic Systems, Inc. | 12/16/1993SE |
| K930166 | Iron Test #'S 42376/93,42324/R1A,42324/R1B,42324/RJIY · Traditional | Em Diagnostic Systems, Inc. | 04/21/1993SE |
| K924691 | Olympus Iron ReagentJIY · Traditional | Olympus Corp. | 12/18/1992SE |
| K923565 | Olympus Iron ReagentJIY · Traditional | Olympus Corp. | 09/28/1992SE |
| K911170 | Therapeutic Drug Monit Control, Set II, Level IIJIY · Traditional | Analytical Control Systems, Inc. | 05/01/1991SE |
| K910143 | Kodak Extachem Clinical Chemistry Slides (Fe)JIY · Traditional | Eastman Kodak Company | 02/04/1991SE |
| K902877 | Total Iron for Manual/AutomatedJIY · Traditional | Catachem, Inc. | 07/27/1990SE |
| K902173 | Coulter Serum Iron/Uibc ReagentJIY · Traditional | Coulter Corp. | 06/12/1990SE |
| K901561 | Iron/Total Iron Binding CapacityJIY · Traditional | Tech-Co, Inc. | 05/17/1990SE |
| K900902 | Iron Liquid Stable ReagentJIY · Traditional | Medical Analysis Systems, Inc. | 03/19/1990SE |
| K895249 | Systemate(Tm) Iron Item Number: 65417JIY · Traditional | Em Diagnostic Systems, Inc. | 10/31/1989SE |
| K892838 | Iron System Pack ReagentsJIY · Traditional | Boehringer Mannheim Corp. | 06/16/1989SE |
| K892863 | Easy-Test Iron (Iron) Item No. 16686JIY · Traditional | Em Diagnostic Systems, Inc. | 06/07/1989SE |
| K890573 | Kenlor Total Iron, Uibc/Tibc Assay KitJIY · Traditional | Kenlor Industries, Inc. | 03/24/1989SE |
| K890395 | Biotrol Iron ReagentJIY · Traditional | Biotrol, USA, Inc. | 03/08/1989SE |
| K890304 | Iron Reagents Item Number: SR1017JIY · Traditional | Em Diagnostic Systems, Inc. | 02/10/1989SE |
| K890034 | Photometric Method, Iron (Non-Heme) (75JIY)JIY · Traditional | American Monitor Corp. | 02/03/1989SE |
| K884355 | Kodak Ektachem Clinical Chemistry Slides (Fe)JIY · Traditional | Eastman Kodak Company | 12/16/1988SE |
| K883792 | Total Iron for Continuous Flow InstrumentsJIY · Traditional | Catachem, Inc. | 10/12/1988SE |
| K881202 | Iron TestJIY · Traditional | Sclavo, Inc. | 04/28/1988SE |
| K881167 | Iron ProcedureJIY · Traditional | Data Medical Associates, Inc. | 04/28/1988SE |
| K881104 | Paramax Iron ReagentJIY · Traditional | Baxter Healthcare Corp | 04/28/1988SE |
| K880467 | Stanbio Cab Total Iron Procedure, LiquicolorJIY · Traditional | Stanbio Laboratory | 03/24/1988SE |
| K874918 | Iron ProcedureJIY · Traditional | Data Medical Associates, Inc. | 02/11/1988SE |
| K874263 | Wako(Tm) Fe CJIY · Traditional | Wako Chemicals USA, Inc. | 11/23/1987SE |
| K870986 | Liquid-Stat Iron Reagent Kit & Tibc Reagent KitJIY · Traditional | Beckman Instruments, Inc. | 04/13/1987SE |
| K871284 | Flow Pac Total Iron REAGENTS:2183,2349,2312,014339JIY · Traditional | American Research Products Co. | 04/08/1987SE |
| K870144 | Iron(Irn) Testpack, Item No. 67659/95JIY · Traditional | Em Diagnostic Systems, Inc. | 02/20/1987SE |
| K864819 | Raichem (Tm)Serum Iron and Tibc ReagentsJIY · Traditional | Reagents Applications, Inc. | 02/12/1987SE |
| K864882 | Ferrozine (Colorimetric) Iron Binding CapacityJIY · Traditional | Pointe Scientific, Inc., | 01/21/1987SE |
| K863109 | FerrofastJIY · Traditional | J. D. Assoc. | 11/24/1986SE |
| K863266 | Iron ProcedureJIY · Traditional | Data Medical Associates, Inc. | 09/11/1986SE |
| K861652 | Iron ProcedureJIY · Traditional | Data Medical Associates, Inc. | 05/29/1986SE |
| K860799 | Analyte Iron/Technicon Chem 1 SystemJIY · Traditional | Technicon Instruments Corp. | 04/03/1986SE |
| K860478 | Serum Iron & Iron Binding Reagent SetJIY · Traditional | Sterling Diagnostics, Inc. | 03/14/1986SE |
| K852161 | Serum Iron/Vibc Reagent SetJIY · Traditional | Livonia Diagnostics, Inc. | 06/10/1985SE |
| K851394 | Sandare Iron ProcedureJIY · Traditional | Sandare Chemical Co., Inc. | 04/30/1985SE |
| K845020 | Syste Mate Iron, Hem No. 67224JIY · Traditional | Em Diagnostic Systems, Inc. | 01/28/1985SE |
| K843255 | Technicon RA-1000 Sys Iron for SerumJIY · Traditional | Technicon Instruments Corp. | 09/14/1984SE |
| K841887 | Paramax Iron Blank ReagentJIY · Traditional | American Dade | 06/22/1984SE |
| K841886 | Paramax Iron ReagentJIY · Traditional | American Dade | 06/22/1984SE |
| K833017 | Serum Iron & TIBC#65084 & 65085JIY · Traditional | Emd Chemicals, Inc. | 11/03/1983SE |
| K831201 | Serum IRON-PTF-600JIY · Traditional | American Monitor Corp. | 05/25/1983SE |
| K821184 | Spin Chem Reagents & StandardsJIY · Traditional | Smithkline Diagnostics, Inc. | 05/24/1982SE |
| K812840 | Serum Iron Reagent SetJIY · Traditional | Anco Medical Reagents & Assoc. | 12/03/1981SE |
| K812777 | Direct Iron Reagent SetJIY · Traditional | The Dow Chemical Co. | 10/19/1981SE |
| K800677 | Reagents for Determ. Serum Iron in HumanJIY · Traditional | Diagnostic Solutions, Inc. | 05/28/1980SE |
| K782160 | Total Iron in SerumJIY · Traditional | Fisher Scientific Co., LLC | 01/26/1979SE |
| K781865 | Iron Binding Capicity Model 0370JIY · Traditional | Stanbio Laboratory | 12/04/1978SE |
| K771838 | Serum IronJIY · Traditional | Gamma Enterprises, Inc. | 11/03/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0742-2026 Class II | Iron Deficiency TestDistribution without premarket approval/clearance. | Get Tested International AB | 11/03/2025Open, Classified |
| Z-1549-2024 Class II | Atellica CH Iron3 - IVD use in the quantitative measurement of iron in human serum and…Potential for falsely elevated Chol_2, LDLC, and Trig_2 results on the Atellica CH and Atellica CI analyzers… | Siemens Healthcare Diagnostics, Inc. | 03/13/2024Open, Classified |
| Z-0326-2024 Class II | Alinity c Iron Reagent, Reference Number 08P3920A high recovery of Iron assay has been observed at some customer sites. Internal studies confirmed the… | Sentinel CH SpA | 09/29/2023Open, Classified |
| Z-0325-2024 Class II | IRON assay, Reference Numbers 6K95-41 and 6K95-30A high recovery of Iron assay has been observed at some customer sites. Internal studies confirmed the… | Sentinel CH SpA | 09/29/2023Open, Classified |
| Z-1498-2022 Class II | Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use in the quantitative…Falsely Elevated Atellica CH Microalbumin_2 (ALB_2) Results due to Reagent Carryover from the Iron_2 Assay.… | Siemens Healthcare Diagnostics, Inc. | 06/28/2022Open, Classified |
| Z-0402-2017 Class III | Dimension IRON Flex reagent cartridgesSiemens Healthcare Diagnostics has become aware of deferoxamine interference with Dimension and Dimension… | Siemens Healthcare Diagnostics, Inc. | 08/25/2016Terminated |
| Z-0401-2017 Class III | Dimension Vista IRON Flex reagent cartridgesSiemens Healthcare Diagnostics has become aware of deferoxamine interference with Dimension and Dimension… | Siemens Healthcare Diagnostics, Inc. | 08/25/2016Terminated |
| Z-0933-2017 Class III | Sterling Diagnostics, Inc. Serum Iron/IBC (Colorimetric) for IN VITRO DIAGNOSTIC USE in…Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of… | Sterling Diagnostics, Inc. | 07/20/2016Terminated |
| Z-0313-2014 Class II | VITROS Chemistry Products Fe Slides packaged as 300 slides/pack catalog number 1515808…Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product… | Ortho-Clinical Diagnostics | 06/12/2013Terminated |
| Z-0452-2013 Class II | Dimension Vista(R) IRON Flex(R) reagent cartridge (K3085) The IRON method is an in vitro…Siemens Healthcare Diagnostics has confirmed the potential for falsely elevated results with IRON Flex(R)… | Siemens Healthcare Diagnostics, Inc. | 10/08/2012Terminated |
| Z-0906-2010 | Pointe Scientific Iron Reagent (R2), for the quantitative determination of serum iron…Turbidity formation could occur, resulting in invalid test results being reported out. | Pointe Scientific, Inc. | 11/16/2009Terminated |
| Z-0905-2010 | Pointe Scientific, Inc. Iron Color Reagent, Pointe Scientific, Inc., Canton, MI.…Turbidity formation could occur, resulting in invalid test results being reported out. | Pointe Scientific, Inc. | 11/16/2009Terminated |
| Z-0904-2010 | Pointe Scientific, Inc. Iron Buffer Reagent, Pointe Scientific, Inc., Canton, MI.…Turbidity formation could occur, resulting in invalid test results being reported out. | Pointe Scientific, Inc. | 11/16/2009Terminated |
| Z-0903-2010 | Pointe Scientific Iron (Ferrozine) R2 Reagent Set, for the quantitative determination of…Turbidity formation could occur, resulting in invalid test results being reported out. | Pointe Scientific, Inc. | 11/16/2009Terminated |
| Z-0902-2010 | Pointe Scientific Iron (Ferrozine) R1 Reagent Set, for the quantitative determination of…Turbidity formation could occur, resulting in invalid test results being reported out. | Pointe Scientific, Inc. | 11/16/2009Terminated |
| Z-0901-2010 | Pointe Scientific Iron (Ferrozine) Reagent Set, for the quantitative determination of…Turbidity formation could occur, resulting in invalid test results being reported out. | Pointe Scientific, Inc. | 11/16/2009Terminated |
| Z-0900-2010 | Pointe Scientific Total Iron Reagent Set, for the quantitative determination of serum…Turbidity formation could occur, resulting in invalid test results being reported out. | Pointe Scientific, Inc. | 11/16/2009Terminated |
| Z-0899-2010 | Pointe Scientific Iron/TIBC Reagent Set, for the quantitative determination of serum…Turbidity formation could occur, resulting in invalid test results being reported out. | Pointe Scientific, Inc. | 11/16/2009Terminated |
| Z-0007-2009 | Roche Diagnostics IRON2, Iron Gen. 2, COBAS INTEGRA, cobas c systems, Roche Diagnostics…Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader. | Roche Diagnostics Corp. | 06/11/2008Terminated |