Photometric Method, Magnesium
FDA product code JGJ · Class I (low risk) · 21 CFR 862.1495 · Clinical Chemistry
90510(k) clearances
0PMA approvals
12recalls
Manufacturers
- Em Diagnostic Systems, Inc. 7
- Technicon Instruments Corp. 6
- Abbott Laboratories 6
- Sigma Chemical Co. 2
- Eastman Kodak Company 2
- Abaxis, Inc. 2
- Olympus Corp. 2
- Data Medical Associates, Inc. 2
- Diagnostic Chemicals, Ltd. (Usa) 2
- Reagents Applications, Inc. 2
- Biotrol, USA, Inc. 2
- Medical Analysis Systems, Inc. 2
- Randox Laboratories, Ltd. 2
- American Dade 1
- Livonia Diagnostics, Inc. 1
- Anco Medical Reagents & Assoc. 1
- Bio-Analytics Laboratories, Inc. 1
- Siemens Healthcare Diagnostics, Inc. 1
- Mallinckrodt Critical Care 1
- Alta Diagnostics, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K181748 | MagnesiumJGJ · Traditional | Abbott Laboratories | 09/12/2018SE |
| K173294 | MagnesiumJGJ · Traditional | Abbott Laboratories | 05/18/2018SE |
| K162200 | Randox RX Daytona Plus Magnesium (MG)JGJ · Traditional | Randox Laboratories, Ltd. | 04/28/2017SE |
| K162399 | Atellica CH Magnesium (Mg)JGJ · Traditional | Siemens Healthcare Diagnostics, Inc. | 01/19/2017SE |
| K122302 | Ace Magnesium RegentJGJ · Special | Alfa Wassermann Diagnostics Technologies, LLC | 08/27/2012SE |
| K111915 | Magnesium AssayJGJ · Traditional | Sekisui Diagnostics P.E.I., Inc. | 12/02/2011SE |
| K092737 | Easyra MG Reagent, Model 10220JGJ · Special | Medica Corp. | 11/17/2009SE |
| K091910 | Piccolo Magnesium Test SystemJGJ · Special | Abaxis, Inc. | 10/01/2009SE |
| K063208 | Magnesium Assay (XB), Models 125-12, 125-50 and 125-S7JGJ · Traditional | Diagnostic Chemicals , Ltd. | 01/19/2007SE |
| K040508 | Vitalab Magnesium ReagentJGJ · Traditional | Clinical Data, Inc. | 03/08/2004SE |
| K040115 | Piccolo Magnesium Test SystemJGJ · Traditional | Abaxis, Inc. | 01/30/2004SE |
| K030010 | Atac Pak Magnesium ReagentJGJ · Traditional | Elan Diagnostics | 03/10/2003SE |
| K012326 | Wiener Lab.Mg-Color Aa, Model 2X50 ML Cat. N 1580001JGJ · Traditional | Wiener Laboratories Saic | 11/08/2001SE |
| K003835 | Jas Magnesium ReagentJGJ · Traditional | Jas Diagnostics, Inc. | 03/23/2001SE |
| K991761 | Magnesium Product No's, 112-01, 112-02JGJ · Traditional | A.P. Total Care, Inc. | 09/02/1999SE |
| K991717 | Careside MGJGJ · Traditional | Careside, Inc. | 08/10/1999SE |
| K981791 | MGJGJ · Traditional | Abbott Laboratories | 10/23/1998SE |
| K983416 | Roche Diagnostics Magnesium Reagent, Cat# 1551353JGJ · Traditional | Boehringer Mannheim Corp. | 10/21/1998SE |
| K981192 | MGJGJ · Traditional | Abbott Laboratories | 05/01/1998SE |
| K974606 | Randox MagnesiumJGJ · Traditional | Randox Laboratories, Ltd. | 02/12/1998SE |
| K964915 | MagnesiumJGJ · Traditional | Derma Media Lab., Inc. | 03/26/1997SE |
| K952426 | Magnesium ReagentJGJ · Traditional | Schiapparelli Biosystems, Inc. | 08/07/1995SE |
| K943001 | Magnesium QvetJGJ · Traditional | Prisma Systems | 12/29/1994SE |
| K944407 | Olympus Magnesium ReagentJGJ · Traditional | Olympus America, Inc. | 12/27/1994SE |
| K944202 | Abbott A-Gent Liquid Magnesium Reagent, ModifiedJGJ · Traditional | Abbott Laboratories | 11/14/1994SE |
| K935183 | Emds Magnesium (MG) TestJGJ · Traditional | Em Diagnostic Systems, Inc. | 12/09/1993SE |
| K930074 | In-Vitro Diagnostic Reagent SetJGJ · Traditional | Horizon Diagnostics, Inc. | 05/11/1993SE |
| K926144 | Urine Magnesium Method for Technicon Chem SystemsJGJ · Traditional | Heraeus Kulzer, Inc. | 01/27/1993SE |
| K924658 | Olympus Magnesium ReagentJGJ · Traditional | Olympus Corp. | 10/19/1992SE |
| K923927 | King Diagnostics Magnesium ReagentJGJ · Traditional | King Diagnostics, Inc. | 09/30/1992SE |
| K923411 | Olympus Magnesium ReagentJGJ · Traditional | Olympus Corp. | 08/18/1992SE |
| K921677 | Biotrol Magnesium (Magon)JGJ · Traditional | Biotrol, USA, Inc. | 05/26/1992SE |
| K920603 | Trace Magnesium - Arsenazo ReagentJGJ · Traditional | Trace America, Inc. | 03/11/1992SE |
| K913764 | Abbott Quickstart Magnesium Test, Item #5A32JGJ · Traditional | Em Diagnostic Systems, Inc. | 11/05/1991SE |
| K912825 | Magnesium Assay Kit, Cat.# 100-12JGJ · Traditional | Diagnostic Chemicals, Ltd. (Usa) | 07/26/1991SE |
| K912321 | Module: Nova Nucleus TMG Module Fluid PackJGJ · Traditional | Nova Biomedical Corp. | 06/17/1991SE |
| K905544 | Magnesium ReagentJGJ · Traditional | Amresco, Inc. | 12/27/1990SE |
| K903306 | Technicon Chem I System Magnesium MethodJGJ · Traditional | Technicon Instruments Corp. | 08/29/1990SE |
| K903341 | MagnesiumJGJ · Traditional | Catachem, Inc. | 08/22/1990SE |
| K902919 | Synermed Magnesium Reagent KitJGJ · Traditional | Synermed, Inc. | 07/31/1990SE |
| K901758 | Roche Reagent for MagnesiumJGJ · Traditional | Roche Diagnostic Systems, Inc. | 05/23/1990SE |
| K901124 | Chem I Clinical Analyzer Urine MagnesiumJGJ · Traditional | Technicon Instruments Corp. | 05/14/1990SE |
| K901265 | Coulter Magnesium ReagentJGJ · Traditional | Coulter Corp. | 03/29/1990SE |
| K894508 | Magnesium Test Item Number: 65419JGJ · Traditional | Em Diagnostic Systems, Inc. | 08/31/1989SE |
| K890798 | Revised Magnesium Test Item Number: SR1019JGJ · Traditional | Em Diagnostic Systems, Inc. | 03/31/1989SE |
| K891355 | Magnesium ReagentJGJ · Traditional | Medical Analysis Systems, Inc. | 03/28/1989SE |
| K883170 | Stanbio Magnesium Test Set, Cat. No 0130JGJ · Traditional | Stanbio Laboratory | 02/07/1989SE |
| K883967 | Beckman Liquid-Stat Magnesium Reagent & StandardJGJ · Traditional | Beckman Instruments, Inc. | 01/27/1989SE |
| K884600 | Technicon System RA-100/ASSIST MagnesiumJGJ · Traditional | Technicon Instruments Corp. | 01/23/1989SE |
| K885022 | Magnesium Test Item Number: SR1019JGJ · Traditional | Em Diagnostic Systems, Inc. | 01/17/1989SE |
| K883972 | Magnesium Reagent (Magon Sulfonate)JGJ · Traditional | Sigma Chemical Co. | 11/10/1988SE |
| K883326 | Technicon Ra(Tm) Systems - MagnesiumJGJ · Traditional | Technicon Instruments Corp. | 10/13/1988SE |
| K882256 | Magnesium Reagent SetJGJ · Traditional | Tech-Neal Scientific, Inc. | 08/08/1988SE |
| K880880 | Raichem(Tm) Magnesium Reagent, EnzymaticJGJ · Traditional | Reagents Applications, Inc. | 05/27/1988SE |
| K881300 | Magnesium Liquid Stable Reagent SetJGJ · Traditional | Medical Analysis Systems, Inc. | 05/17/1988SE |
| K874506 | Use of Technicon Ra Systems Reagents on Assist(R)JGJ · Traditional | Technicon Instruments Corp. | 01/22/1988SE |
| K874822 | Raichem(Tm) Magnesium ReagentJGJ · Traditional | Reagents Applications, Inc. | 01/21/1988SE |
| K874595 | Multichem (R) Magnesium ReagentJGJ · Traditional | Simmler, Inc. | 01/21/1988SE |
| K874576 | Kodak Ektachem DT Slides (MG)JGJ · Traditional | Eastman Kodak Company | 01/21/1988SE |
| K874847 | MagnesiumJGJ · Traditional | Tech-Co, Inc. | 12/18/1987SE |
| K873530 | Paramax Magnesium ReagentJGJ · Traditional | Baxter Healthcare Corp | 12/14/1987SE |
| K873180 | Biotrol Magnesium CalmagiteJGJ · Traditional | Biotrol, USA, Inc. | 09/02/1987SE |
| K870370 | Magnesium Reagent - Calmagite MethodJGJ · Traditional | Trace Scientific , Ltd. | 08/19/1987SE |
| K872311 | Abbott A-Gent Liquid Magnesium ReagentJGJ · Traditional | Abbott Laboratories | 07/09/1987SE |
| K870553 | Easy-Test Magnesium (MG) Item No. 16XXXJGJ · Traditional | Em Diagnostic Systems, Inc. | 03/06/1987SE |
| K863069 | MagnesiometerJGJ · Traditional | J. D. Assoc. | 12/31/1986SE |
| K861386 | Kodak Ektachem Clinical Chemistry Slides (MG)JGJ · Traditional | Eastman Kodak Company | 08/26/1986SE |
| K863002 | Emds(Tm) Magnesium Testpacks, #67671/95JGJ · Traditional | Em Diagnostic Systems, Inc. | 08/19/1986SE |
| K861668 | Magnesium ProcedureJGJ · Traditional | Data Medical Associates, Inc. | 05/27/1986SE |
| K855190 | Magnesium Reagent SetJGJ · Traditional | Technostics Intl. | 02/18/1986SE |
| K860215 | Magnesium Reagent SetJGJ · Traditional | Sterling Diagnostics, Inc. | 02/11/1986SE |
| K853853 | Technicon Chem 1 Sys Analytes Magnesium GGT, UricJGJ · Traditional | Technicon Instruments Corp. | 10/03/1985SE |
| K853592 | MagnesiumJGJ · Traditional | Pointe Scientific, Inc., | 09/16/1985SE |
| K852005 | MG ReagentJGJ · Traditional | Alpkem Corp. | 06/25/1985SE |
| K851657 | Demand MagnesiumJGJ · Traditional | Cooper Biomedical, Inc. | 05/10/1985SE |
| K850381 | Magnesium Reagent for Demand AnalyzerJGJ · Traditional | Advanced Biomedical Methods, Inc. | 03/01/1985SE |
| K844278 | Data-Chem MagnesiumJGJ · Traditional | Data Medical Associates, Inc. | 01/08/1985SE |
| K843893 | Magnesium Reagent SetJGJ · Traditional | Livonia Diagnostics, Inc. | 10/30/1984SE |
| K843031 | Magnesium Assay KitJGJ · Traditional | Diagnostic Chemicals, Ltd. (Usa) | 08/27/1984SE |
| K841259 | Determination of Magnesium in Serum orJGJ · Traditional | Sigma Chemical Co. | 05/07/1984SE |
| K840784 | Paramax Magnesium ReagentJGJ · Traditional | American Dade | 04/13/1984SE |
| K834075 | Magnesium B TestJGJ · Traditional | Wako Chemicals USA, Inc. | 02/03/1984SE |
| K821102 | Megnesium Reagent KitJGJ · Traditional | Anco Medical Reagents & Assoc. | 05/05/1982SE |
| K820976 | Gil Chem Magnesium ReagentJGJ · Traditional | Gilford Diagnostics | 04/26/1982SE |
| K810084 | Magnesium KitJGJ · Traditional | Bio-Analytics Laboratories, Inc. | 01/26/1981SE |
| K803088 | Magnesium Test KitJGJ · Traditional | Mallinckrodt Critical Care | 01/02/1981SE |
| K802091 | American Monitor Magnesium #'S 1036&4021JGJ · Traditional | American Monitor Corp. | 10/10/1980SE |
| K800327 | Magnesium ReagentJGJ · Traditional | Alta Diagnostics, Inc. | 03/25/1980SE |
| K792399 | Elvi MagnesiumJGJ · Traditional | Volu Sol Medical Industries | 12/07/1979SE |
| K771469 | Multistat III Magnesium TestJGJ · Traditional | Instrumentation Laboratory CO | 09/12/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0767-2025 Class II | Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material…Siemens Healthcare Diagnostics is recalling two lots of their Dimension Vista Total Magnesium (MG) Flex… | Siemens Healthcare Diagnostics, Inc. | 11/12/2024Open, Classified |
| Z-1816-2022 Class II | Dimension Magnesium (MG) Flex reagent cartridge Siemens Material Number (SMN)/REF…Dimension Magnesium (MG) Flex reagent cartridge lots may exhibit imprecision for Quality Control (QC) and… | Siemens Healthcare Diagnostics, Inc. | 08/17/2022Open, Classified |
| Z-0830-2022 Class II | Siemens Dimension Vista Magnesium Flex reagent cartridge (MG) Material # 10445158…Dimension Vista Magnesium Flex reagent cartridge lots exhibiting imprecision and intermittent Abnormal Assay… | Siemens Healthcare Diagnostics, Inc. | 01/28/2022Open, Classified |
| Z-0692-2022 Class II | AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850Lipemic interference for the Magnesium serum application failed to meet the performance claim as defined in… | Beckman Coulter Inc. | 12/08/2021Terminated |
| Z-0547-2021 Class II | Randox Rx Series Mg - Product Usage: For the quantitative in vitro determination of…Failing to meet the linearity performance claims quoted on the kit inserts-The linearity is reduced by… | Randox Laboratories Ltd. | 11/13/2020Terminated |
| Z-0546-2021 Class II | Randox Mg R1 - Product Usage: For the quantitative in vitro determination of Magnesium…Failing to meet the linearity performance claims quoted on the kit inserts-The linearity is reduced by… | Randox Laboratories Ltd. | 11/13/2020Terminated |
| Z-0971-2019 Class II | ARCHITECT MAGNESIUM, (a) REF 7D70-21, (b) 7D70-31 The Magnesium assay is used for the…Abbott internal testing has identified that the Magnesium urine application demonstrates depressed urine… | Abbott Laboratories, Inc | 01/02/2019Terminated |
| Z-0725-2017 Class II | Magnesium on RX Imola analyser IVDAccording to the firm, Carry over was observed when the amylase or pancreatic amylase test is run directly… | Randox Laboratories, Limited | 04/14/2016Terminated |
| Z-0339-2016 Class II | Dimension Vista System (MG) ; Flex reagent cartridge Catalog number K3057, SMN 10445158.…Erroneous low results on a small number of reagent wells. There is the potential for under-recovery on… | Siemens Healthcare Diagnostics, Inc. | 09/30/2015Terminated |
| Z-2692-2014 Class II | ABX PENTRA Magnesium RTU Reagent, Part No. A11A01646 Product Usage: ABX PENTRA Magnesium…Horiba Medical is recalling the ABX PENTRA Magnesium RTU Reagent because the on-board stability claims has… | Horiba Instruments, Inc dba Horiba Medical | 08/11/2014Terminated |
| Z-0318-2014 Class II | VITROS Chemistry Products Mg Slides packaged as 300 slides/pack catalog number 8255093…Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product… | Ortho-Clinical Diagnostics | 06/12/2013Terminated |
| Z-1433-2012 | Dimension Vista(R) MG Flex(R) Reagent Cartridge The Dimension Vista(R) MG method is an…Firm has confirmed a negative shift of approximately 0.2mg/dL [0.08 mmol/L] in patient and QC samples when… | Siemens Healthcare Diagnostics, Inc. | 02/17/2012Terminated |