Urinary Homocystine (Nonquantitative) Test System
FDA product code LPS · Class II (moderate risk) · 21 CFR 862.1377 · Clinical Chemistry
29510(k) clearances
0PMA approvals
17recalls
Manufacturers
- Diazyme Laboratories 4
- Axis-Shield Diagnostics, Ltd. 3
- Axis Biochemicals, Asa 2
- Catch Incorporated 2
- Bayer Diagnostics Corp. 2
- Anticancer, Inc. 2
- Ortho-Clinical Diagnostics 2
- Dade Behring, Inc. 2
- Tosoh Bioscience Inc 1
- Roche 1
- Teco Diagnostics 1
- Instrumentation Laboratory CO 1
- Polymedco, Inc. 1
- Intersect Systems, Inc. 1
- Diagnostic Products Corp. 1
- Bio-Rad 1
- Abbott Laboratories 1
- Drew Scientific , Ltd. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K123930 | Vitros Chemistry Products Hcy 2 Reagent, Calibrator Kit 27, Hcy 2 Performance Verifiers…LPS · Traditional | Ortho-Clinical Diagnostics, Inc. | 05/15/2013SE |
| K121053 | Diazyme Homocysteine Poc Test KitLPS · Traditional | Diazyme Laboratories | 07/31/2012SE |
| K121533 | ST Aia-Pack Homocysteine; ST Aia-Pack Homocysteine Calibrator Set; Aia-Pack Homocysteine…LPS · Traditional | Tosoh Bioscience, Inc. | 06/15/2012SE |
| K113793 | Homocysteine TestLPS · Traditional | Roche | 06/05/2012SE |
| K112790 | Axis-Shield 3-REAGENT Homocysteine Assay for SynchronLPS · Traditional | Axis-Shield Diagnostics, Ltd. | 05/07/2012SE |
| K083222 | Axis-Shield Liquid Stable (LS) 2-PART Homocysteine Reagent, Model FHRK100LPS · Traditional | Axis-Shield Diagnostics, Ltd. | 07/31/2009SE |
| K080851 | A/C Portable Enzymatic Homocysteine AssayLPS · Traditional | Anticancer, Inc. | 10/10/2008SE |
| K073640 | Architect Homocysteine Reagents, Calibrators and ControlsLPS · Traditional | Axis-Shield Diagnostics, Ltd. | 04/24/2008SE |
| K071971 | Diazyme Homocysteine 2 Reagent Enzymatic Assay Kit, and Calibrators, Model(S) Dzxxxa…LPS · Special | Diazyme Laboratories | 09/17/2007SE |
| K063701 | Teco Homocysteine Enzymatic AssayLPS · Traditional | Teco Diagnostics | 04/11/2007SE |
| K063206 | Dimension Vista Hcys Flex Reagent Cartridge; Protein 1 Calibrator; Protein 1 Control…LPS · Traditional | Dade Behring, Inc. | 12/28/2006SE |
| K062808 | Liquid Stable (LS) 2-PART Homocysteine ReagentLPS · Special | Catch Incorporated | 10/13/2006SE |
| K061598 | Hemosil Homocysteine and ControlsLPS · Traditional | Instrumentation Laboratory CO | 09/22/2006SE |
| K061588 | Vitros Chemistry Products Hcy Reagent, Vitros Chemistry Products Calibrator Kit 27, Hcy…LPS · Traditional | Ortho-Clinical Diagnostics, Inc. | 07/21/2006SE |
| K061296 | Diazyme Homocysteine Enzymatic Assay Kit for Cobas Integra and Homocysteine CalibratorLPS · Special | Diazyme Laboratories | 06/13/2006SE |
| K052788 | N Latex Hcy, N Protein Standard SL, N/T Protein Control L/M/HLPS · Traditional | Dade Behring, Inc. | 03/29/2006SE |
| K033706 | Polymedco Homocysteine Test for the Poly-Chem and Hitachi Chemistry SystemsLPS · Traditional | Polymedco, Inc. | 02/04/2004SE |
| K032012 | Homocysteine Microtiter Plate AssayLPS · Traditional | Diazyme Laboratories | 09/03/2003SE |
| K030754 | A/C Enzymatic Homocysteine AssayLPS · Traditional | Anticancer, Inc. | 07/11/2003SE |
| K013606 | Acs 180 Homocysteine AssayLPS · Traditional | Bayer Diagnostics Corp. | 12/21/2001SE |
| K013406 | Advia Centaur Homocysteine AssayLPS · Traditional | Bayer Diagnostics Corp. | 12/18/2001SE |
| K011692 | Homogeneous Enzymic Homocysteine ReagentLPS · Traditional | Intersect Systems, Inc. | 07/25/2001SE |
| K011689 | Homogeneous Enzymic Homocysteine ReagentLPS · Traditional | Catch, Inc. | 07/25/2001SE |
| K003597 | Immulite Homocysteine Model LKHO1 / Immulite 2000 Homocysteine Model L2KHO2LPS · Traditional | Diagnostic Products Corp. | 02/05/2001SE |
| K993107 | Bio-Rad Homocysteine by HPLCLPS · Traditional | Bio-Rad | 12/21/1999SE |
| K992858 | Abbott Axsym HomocysteineLPS · Traditional | Abbott Laboratories | 10/25/1999SE |
| K992274 | Modification to Imx HomocysteineLPS · Traditional | Axis Biochemicals, Asa | 10/06/1999SE |
| K982003 | DS30 Hcy Homocysteine Assay KitLPS · Traditional | Drew Scientific , Ltd. | 02/11/1999SE |
| K980907 | Axis Homocysteine Enzyme ImmunoassayLPS · Traditional | Axis Biochemicals, Asa | 10/16/1998SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0489-2025 Class II | cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on…Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can… | Roche Diagnostics Operations, Inc. | 10/17/2024Open, Classified |
| Z-0679-2020 Class II | Roche Homocysteine-In vitro test for the quantitative determination of total…Homocysteine Reagent, Calibration Failures and Quality Control Recovery Issues on cobas c 701 and 702 modules | Roche Diagnostics Operations, Inc. | 10/04/2019Terminated |
| Z-0744-2020 Class II | Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR1000 -…There is a potential performance issue as detected by an under-recovery of sample results during routine… | Axis-Shield Diagnostics, Ltd. | 09/16/2019Open, Classified |
| Z-0743-2020 Class II | Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR100 -…There is a potential performance issue as detected by an under-recovery of sample results during routine… | Axis-Shield Diagnostics, Ltd. | 09/16/2019Open, Classified |
| Z-0742-2020 Class II | Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHBC100 -…There is a potential performance issue as detected by an under-recovery of sample results during routine… | Axis-Shield Diagnostics, Ltd. | 09/16/2019Open, Classified |
| Z-0675-2019 Class II | ST AIA-PACK Homocysteine (HCY) is designed for IN VITRO DIAGNOSTIC USE ONLY for the… | Tosoh Bioscience Inc | 11/30/2018Terminated |
| Z-1227-2017 Class II | N Latex HCY REAGENT, REF/Catalog OPAX03 /SMN 10445973 , IVD Product Usage: In-vitro…The firm confirmed a reduced once-opened and on-board stability for N Latex Homocysteine (HCY) OPAX03 lot… | Siemens Healthcare Diagnostics, Inc. | 01/11/2017Terminated |
| Z-2241-2016 Class II | Dimension Vista Homocysteine Flex Reagent Cartridge (HCYS), Device Listing No.: D017878…Reagent lots # 15243MA and 15243MB shows a reduced stability once opened that does not meet the Instructions… | CSL Behring GmbH | 05/17/2016Terminated |
| Z-2063-2016 Class II | Liquid stable 2 part Homocysteine Reagent, for in vitro quantitative determination of…Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under… | Medtest Holdings, Inc. | 04/03/2015Terminated |
| Z-1622-2015 Class II | Homocysteine test system - Homocysteine Reagent. 05385415190; Homocysteine 100 Tests…Customers complained about under-recovery of non-Roche controls and discrepant low patient results with… | Roche Diagnostics Operations, Inc. | 03/23/2015Terminated |
| Z-1946-2015 Class II | Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT; 100 test format, 1000 test…Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under… | Axis-Shield Diagnostics, Ltd. | 03/20/2015Terminated |
| Z-0541-2014 Class II | Siemens Dimension Vista Homocysteine Flex Reagent Cartridge The HCYS method is an in…Dimension Vista HCYS lot 13064MA shows erratic recovery of QC and patient samples. | Siemens Healthcare Diagnostics, Inc. | 09/18/2013Terminated |
| Z-1960-2014 Class II | ADVIA Centaur HCY Diluent - 10mL Bottle Catalog number 09877493 (124533), SMN 10310370…ADVIA Centaur Homocysteine dilution recovery on the diluent identified the percent recovery for the 1:10… | Siemens Healthcare Diagnostics, Inc | 06/25/2013Terminated |
| Z-1556-2013 Class II | VITROS Chemistry Products-HCY Reagent packaged in a kit carton. Catalog# 6802002. Used…The firm is recalling the specific lot due to lower than expected results. | Ortho-Clinical Diagnostics | 04/01/2013Terminated |
| Z-0253-2013 Class III | Siemens Dimension Vista(R) Homocysteine Flex(R) Reagent Cartridge This is an in vitro…Cartridges are leaking. The leaking is observed when opening the wrapper that holds the reagent cartridge. | Siemens Healthcare Diagnostics, Inc. | 08/03/2012Terminated |
| Z-0921-2012 | Homogeneous Enzymic Homocysteine Reagent Two Part Reagent Method. Catalog Number…Homogeneous Enzymic Homocysteine Reagent Two Part Reagent Method will not calibrate due to Reagent R1 had… | Catch Incorporated | 06/27/2011Terminated |
| Z-0448-2009 | Homocysteine Reagent Test Kit. The Homocysteine test kits were manufactured under 2…A high homocysteine level can be reported as falsely low. | Catch Incorporated | 01/18/2007Terminated |