Product code LPS
- Device name
- Urinary Homocystine (Nonquantitative) Test System
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation number
- 862.1377
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K123930 | VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND III | Ortho-Clinical Diagnostics, Inc. | 2013-05-15 |
| K121053 | DIAZYME HOMOCYSTEINE POC TEST KIT | Diazyme Laboratories | 2012-07-31 |
| K121533 | ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SET | Tosoh Bioscience, Inc. | 2012-06-15 |
| K113793 | HOMOCYSTEINE TEST | Roche | 2012-06-05 |
| K112790 | AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON | Axis-Shield Diagnostics, Ltd. | 2012-05-07 |
| K083222 | AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100 | Axis-Shield Diagnostics, Ltd. | 2009-07-31 |
| K080851 | A/C PORTABLE ENZYMATIC HOMOCYSTEINE ASSAY | Anticancer, Inc. | 2008-10-10 |
| K073640 | ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS | Axis-Shield Diagnostics, Ltd. | 2008-04-24 |
| K071971 | DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRATORS, MODEL(S) DZXXXA, DZXXXA-CAL | Diazyme Laboratories | 2007-09-17 |
| K063701 | TECO HOMOCYSTEINE ENZYMATIC ASSAY | Teco Diagnostics | 2007-04-11 |
| K063206 | DIMENSION VISTA HCYS FLEX REAGENT CARTRIDGE; PROTEIN 1 CALIBRATOR; PROTEIN 1 CONTROL LOW, MEDIUM, HIGH | Dade Behring, Inc. | 2006-12-28 |
| K062808 | LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT | Catch Incorporated | 2006-10-13 |
| K061598 | HEMOSIL HOMOCYSTEINE AND CONTROLS | Instrumentation Laboratory CO | 2006-09-22 |
| K061588 | VITROS CHEMISTRY PRODUCTS HCY REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 27, HCY PERFORMANCE VERIFIERS | Ortho-Clinical Diagnostics, Inc. | 2006-07-21 |
| K061296 | DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND HOMOCYSTEINE CALIBRATOR | Diazyme Laboratories | 2006-06-13 |
| K052788 | N LATEX HCY, N PROTEIN STANDARD SL, N/T PROTEIN CONTROL L/M/H | Dade Behring, Inc. | 2006-03-29 |
| K033706 | POLYMEDCO HOMOCYSTEINE TEST FOR THE POLY-CHEM AND HITACHI CHEMISTRY SYSTEMS | Polymedco, Inc. | 2004-02-04 |
| K032012 | HOMOCYSTEINE MICROTITER PLATE ASSAY | Diazyme Laboratories | 2003-09-03 |
| K030754 | A/C ENZYMATIC HOMOCYSTEINE ASSAY | Anticancer, Inc. | 2003-07-11 |
| K013606 | ACS 180 HOMOCYSTEINE ASSAY | Bayer Diagnostics Corp. | 2001-12-21 |
| K013406 | ADVIA CENTAUR HOMOCYSTEINE ASSAY | Bayer Diagnostics Corp. | 2001-12-18 |
| K011689 | HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT | Catch, Inc. | 2001-07-25 |
| K011692 | HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT | Intersect Systems, Inc. | 2001-07-25 |
| K003597 | IMMULITE HOMOCYSTEINE MODEL LKHO1 / IMMULITE 2000 HOMOCYSTEINE MODEL L2KHO2 | Diagnostic Products Corp. | 2001-02-05 |
| K993107 | BIO-RAD HOMOCYSTEINE BY HPLC | Bio-Rad | 1999-12-21 |
| K992858 | ABBOTT AXSYM HOMOCYSTEINE | Abbott Laboratories | 1999-10-25 |
| K992274 | MODIFICATION TO IMX HOMOCYSTEINE | Axis Biochemicals, Asa | 1999-10-06 |
| K982003 | DS30 HCY HOMOCYSTEINE ASSAY KIT | Drew Scientific , Ltd. | 1999-02-11 |
| K980907 | AXIS HOMOCYSTEINE ENZYME IMMUNOASSAY | Axis Biochemicals, Asa | 1998-10-16 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00817089021464 | Diazyme | DIAZYME LABORATORIES, INC. | 2020-07-21 |
| 00811727015877 | Pointe Homocysteine for BS480 | HORIBA INSTRUMENTS INCORPORATED | 2020-05-28 |
| 07613336121290 | Homocysteine Enzymatic Assay | Roche Diagnostics GmbH | 2020-03-16 |
| 00817089020955 | Diazyme | DIAZYME LABORATORIES, INC. | 2016-11-03 |
| 00817089020306 | Diazyme | DIAZYME LABORATORIES, INC. | 2016-11-03 |
| 00817089020948 | Diazyme | DIAZYME LABORATORIES, INC. | 2016-11-03 |
| 00842768006715 | N Latex HCY | Siemens Healthcare Diagnostics Products GmbH | 2016-09-24 |
| 00842768006128 | DImension Vista® Homocysteine Flex® reagent cartridge | Siemens Healthcare Diagnostics Products GmbH | 2016-09-24 |
| 05055273208894 | HCY | RANDOX LABORATORIES LIMITED | 2016-09-24 |
| 04560189212817 | ST AIA-PACK Homocysteine Pretreatment Set | TOSOH CORPORATION | 2016-09-24 |
| 14560189212777 | ST AIA-PACK Homocysteine | TOSOH CORPORATION | 2016-09-24 |
| 08426950453024 | HemosIL Homocysteine | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 04015630927326 | Homocysteine Enzymatic Assay | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630929979 | Homocysteine Enzymatic Assay | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630933631 | Homocysteine Enzymatic Assay | Roche Diagnostics GmbH | 2016-09-20 |
| 00817302020014 | CAROLINA LIQUID CHEMISTRIES CORP. ® HCY RGT. KIT BL-201 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2016-09-01 |
| 00817302020090 | CAROLINA LIQUID CHEMISTRIES CORP.® HCY LEVEL 1 CONTROL KIT PART# CC051 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2016-09-01 |
| 00817302022285 | CAROLINA LIQUID CHEMISTRIES CORP.® HCY RGT. KIT Product No. ST201 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2016-09-01 |
| 00817302022278 | CAROLINA LIQUID CHEMISTRIES CORP.® HCY RGT. KIT AU-201-300 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2016-09-01 |
| 00817302020113 | CAROLINA LIQUID CHEMISTRIES CORP.® HCY LEVEL 3 CONTROL KIT PART# CC053 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2016-09-01 |
| 00817302020106 | CAROLINA LIQUID CHEMISTRIES CORP.® HCY LEVEL 2 CONTROL KIT PART# CC052 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2016-09-01 |
| 00817302020021 | CAROLINA LIQUID CHEMISTRIES CORP.® HCY RGT. KIT AU-201 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2016-09-01 |
| 10758750030156 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. | 2016-08-10 |
| 05055845400282 | Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent | AXIS-SHIELD DIAGNOSTICS LIMITED | 2016-07-01 |
| 05055845400169 | Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent Kit | AXIS-SHIELD DIAGNOSTICS LIMITED | 2016-07-01 |
| 05055845400084 | 3-Reagent Homocysteine Assay for SYNCHRON UniCel | AXIS-SHIELD DIAGNOSTICS LIMITED | 2016-07-01 |
| 05055845400015 | Axis® Homocysteine EIA | AXIS-SHIELD DIAGNOSTICS LIMITED | 2016-06-13 |
| 00380740001254 | ARCHITECT | Abbott GmbH | 2016-06-06 |
| 00380740001230 | ARCHITECT | Abbott GmbH | 2016-06-06 |
| 00380740001223 | ARCHITECT | Abbott GmbH | 2016-06-06 |