Urinary Homocystine (Nonquantitative) Test System
The Urinary Homocystine (Nonquantitative) Test System is an in vitro diagnostic device used to detect the presence of homocystine in urine, which can indicate homocystinuria, an inherited metabolic disorder affecting amino acid metabolism. It is classified as a Class 2 (moderate risk) device, subject to general and special controls, and requires 510(k) premarket notification before marketing. The product code is LPS, regulated under 21 CFR 862.1377, within the Clinical Chemistry medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.
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Basic Information
- Product Code
- LPS
- Device Class
- FDA class 2
- Regulation Number
- 862.1377
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 29 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K123930 | VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND III | May 15, 2013 | Substantially Equivalent | Ortho-Clinical Diagnostics, Inc. |
| K121053 | DIAZYME HOMOCYSTEINE POC TEST KIT | Jul 31, 2012 | Substantially Equivalent | Diazyme Laboratories |
| K121533 | ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SET | Jun 15, 2012 | Substantially Equivalent | Tosoh Bioscience, Inc. |
| K113793 | HOMOCYSTEINE TEST | Jun 05, 2012 | Substantially Equivalent | Roche |
| K112790 | AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON | May 07, 2012 | Substantially Equivalent | Axis-Shield Diagnostics, Ltd. |
| K083222 | AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100 | Jul 31, 2009 | Substantially Equivalent | Axis-Shield Diagnostics, Ltd. |
| K080851 | A/C PORTABLE ENZYMATIC HOMOCYSTEINE ASSAY | Oct 10, 2008 | Substantially Equivalent | Anticancer, Inc. |
| K073640 | ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS | Apr 24, 2008 | Substantially Equivalent | Axis-Shield Diagnostics, Ltd. |
| K071971 | DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRATORS, MODEL(S) DZXXXA, DZXXXA-CAL | Sep 17, 2007 | Substantially Equivalent | Diazyme Laboratories |
| K063701 | TECO HOMOCYSTEINE ENZYMATIC ASSAY | Apr 11, 2007 | Substantially Equivalent | Teco Diagnostics |
| K063206 | DIMENSION VISTA HCYS FLEX REAGENT CARTRIDGE; PROTEIN 1 CALIBRATOR; PROTEIN 1 CONTROL LOW, MEDIUM, HIGH | Dec 28, 2006 | Substantially Equivalent | Dade Behring, Inc. |
| K062808 | LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT | Oct 13, 2006 | Substantially Equivalent | Catch Incorporated |
| K061598 | HEMOSIL HOMOCYSTEINE AND CONTROLS | Sep 22, 2006 | Substantially Equivalent | Instrumentation Laboratory CO |
| K061588 | VITROS CHEMISTRY PRODUCTS HCY REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 27, HCY PERFORMANCE VERIFIERS | Jul 21, 2006 | Substantially Equivalent | Ortho-Clinical Diagnostics, Inc. |
| K061296 | DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND HOMOCYSTEINE CALIBRATOR | Jun 13, 2006 | Substantially Equivalent | Diazyme Laboratories |
| K052788 | N LATEX HCY, N PROTEIN STANDARD SL, N/T PROTEIN CONTROL L/M/H | Mar 29, 2006 | Substantially Equivalent | Dade Behring, Inc. |
| K033706 | POLYMEDCO HOMOCYSTEINE TEST FOR THE POLY-CHEM AND HITACHI CHEMISTRY SYSTEMS | Feb 04, 2004 | Substantially Equivalent | Polymedco, Inc. |
| K032012 | HOMOCYSTEINE MICROTITER PLATE ASSAY | Sep 03, 2003 | Substantially Equivalent | Diazyme Laboratories |
| K030754 | A/C ENZYMATIC HOMOCYSTEINE ASSAY | Jul 11, 2003 | Substantially Equivalent | Anticancer, Inc. |
| K013606 | ACS 180 HOMOCYSTEINE ASSAY | Dec 21, 2001 | Substantially Equivalent | Bayer Diagnostics Corp. |
| K013406 | ADVIA CENTAUR HOMOCYSTEINE ASSAY | Dec 18, 2001 | Substantially Equivalent | Bayer Diagnostics Corp. |
| K011692 | HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT | Jul 25, 2001 | Substantially Equivalent | Intersect Systems, Inc. |
| K011689 | HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT | Jul 25, 2001 | Substantially Equivalent | Catch, Inc. |
| K003597 | IMMULITE HOMOCYSTEINE MODEL LKHO1 / IMMULITE 2000 HOMOCYSTEINE MODEL L2KHO2 | Feb 05, 2001 | Substantially Equivalent | Diagnostic Products Corp. |
| K993107 | BIO-RAD HOMOCYSTEINE BY HPLC | Dec 21, 1999 | Substantially Equivalent | Bio-Rad |
| K992858 | ABBOTT AXSYM HOMOCYSTEINE | Oct 25, 1999 | Substantially Equivalent | Abbott Laboratories |
| K992274 | MODIFICATION TO IMX HOMOCYSTEINE | Oct 06, 1999 | Substantially Equivalent | Axis Biochemicals, Asa |
| K982003 | DS30 HCY HOMOCYSTEINE ASSAY KIT | Feb 11, 1999 | Substantially Equivalent | Drew Scientific , Ltd. |
| K980907 | AXIS HOMOCYSTEINE ENZYME IMMUNOASSAY | Oct 16, 1998 | Substantially Equivalent | Axis Biochemicals, Asa |
FEI Numbers
This FDA classification entry is associated with 28 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 28 registration numbers. Click on an entry to view related FDA registrations.