LPS · Urinary Homocystine (Nonquantitative) Test System
Clinical Chemistry · 21 CFR 862.1377 · Class 2
Overview
| Product Code | LPS |
|---|---|
| Device Name | Urinary Homocystine (Nonquantitative) Test System |
| Regulation | 21 CFR 862.1377 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
A urinary homocystine (nonquantitative) test system is a device intended to identify homocystine (an analogue of the amino acid cystine) in urine. The identification of urinary homocystine is used in the diagnosis and treatment of homocystinuria (homosystine in urine), a heritable metabolic disorder which may cause mental retardation.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 29)
Showing 20 most recent of 29 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K123930 | VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND III | Ortho-Clinical Diagnostics, Inc. | May 15, 2013 | SESE |
| K121053 | DIAZYME HOMOCYSTEINE POC TEST KIT | Diazyme Laboratories | Jul 31, 2012 | SESE |
| K121533 | ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SET | Tosoh Bioscience, Inc. | Jun 15, 2012 | SESE |
| K113793 | HOMOCYSTEINE TEST | Roche | Jun 5, 2012 | SESE |
| K112790 | AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON | Axis-Shield Diagnostics, Ltd. | May 7, 2012 | SESE |
| K083222 | AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100 | Axis-Shield Diagnostics, Ltd. | Jul 31, 2009 | SESE |
| K080851 | A/C PORTABLE ENZYMATIC HOMOCYSTEINE ASSAY | Anticancer, Inc. | Oct 10, 2008 | SESE |
| K073640 | ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS | Axis-Shield Diagnostics, Ltd. | Apr 24, 2008 | SESE |
| K071971 | DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRATORS, MODEL(S) DZXXXA, DZXXXA-CAL | Diazyme Laboratories | Sep 17, 2007 | SESE |
| K063701 | TECO HOMOCYSTEINE ENZYMATIC ASSAY | Teco Diagnostics | Apr 11, 2007 | SESE |
| K063206 | DIMENSION VISTA HCYS FLEX REAGENT CARTRIDGE; PROTEIN 1 CALIBRATOR; PROTEIN 1 CONTROL LOW, MEDIUM, HIGH | Dade Behring, Inc. | Dec 28, 2006 | SESE |
| K062808 | LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT | Catch Incorporated | Oct 13, 2006 | SESE |
| K061598 | HEMOSIL HOMOCYSTEINE AND CONTROLS | Instrumentation Laboratory CO | Sep 22, 2006 | SESE |
| K061588 | VITROS CHEMISTRY PRODUCTS HCY REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 27, HCY PERFORMANCE VERIFIERS | Ortho-Clinical Diagnostics, Inc. | Jul 21, 2006 | SESE |
| K061296 | DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND HOMOCYSTEINE CALIBRATOR | Diazyme Laboratories | Jun 13, 2006 | SESE |
| K052788 | N LATEX HCY, N PROTEIN STANDARD SL, N/T PROTEIN CONTROL L/M/H | Dade Behring, Inc. | Mar 29, 2006 | SESE |
| K033706 | POLYMEDCO HOMOCYSTEINE TEST FOR THE POLY-CHEM AND HITACHI CHEMISTRY SYSTEMS | Polymedco, Inc. | Feb 4, 2004 | SESE |
| K032012 | HOMOCYSTEINE MICROTITER PLATE ASSAY | Diazyme Laboratories | Sep 3, 2003 | SESE |
| K030754 | A/C ENZYMATIC HOMOCYSTEINE ASSAY | Anticancer, Inc. | Jul 11, 2003 | SESE |
| K013606 | ACS 180 HOMOCYSTEINE ASSAY | Bayer Diagnostics Corp. | Dec 21, 2001 | SESE |
Top Applicants
- Diazyme Laboratories — 4 clearances
- Axis-Shield Diagnostics, Ltd. — 3 clearances
- Anticancer, Inc. — 2 clearances
- Axis Biochemicals, Asa — 2 clearances
- Bayer Diagnostics Corp. — 2 clearances
