NDY · Test, Cystatin C
Clinical Chemistry · 21 CFR 862.1225 · Class 2
Overview
| Product Code | NDY |
|---|---|
| Device Name | Test, Cystatin C |
| Regulation | 21 CFR 862.1225 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 22)
Showing 20 most recent of 22 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K242585 | Cystatin C | SENTINEL CH. SpA | May 16, 2025 | SESE |
| K181082 | ADVIA Chemistry Cystatin C_2 Assay (CYSC_2) | Siemens Healthcare Diagnostics, Inc. | May 25, 2018 | SESE |
| K171072 | N Latex Cystatin C; N Protein Standard UY | Siemens Healthcare Diagnostics Products GmbH | May 12, 2017 | SESE |
| K161817 | Tina-quant Cystatin C Gen.2 | Roche Diagnostics Operations (Rdo) | Jul 27, 2016 | SESE |
| K141143 | COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR, CYSTATIN C GEN.2 CONTROL SET | Roche Diagnostics | Jul 17, 2014 | SESE |
| K111664 | DIAZYME CYSTATIN C POC TEST KIT | Diazyme Laboratories | Mar 30, 2012 | SESE |
| K093137 | K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL | Kamiya Biomedical Co. | Sep 28, 2010 | SESE |
| K093960 | ST AIA-PACK CYSTATIN C, MODEL 025217 | Tosoh Bioscience, Inc. | Sep 14, 2010 | SESE |
| K093680 | DIAZYME CYSTATIN C ASSAY | Diazyme Laboratories | Apr 8, 2010 | SESE |
| K083906 | ADVIA CHEMISTRY CYSTATIN C REAGENT, ADVIA CHEMISTRY CYSTATIN C CALIBRATOR, MODELS P/N 04851534, P/N 10376487 | Siemens Healthcare Diagnostics | Mar 11, 2009 | SESE |
| K081875 | GENTIAN CYSTATIN C IMMUNOASSAY | Gentian AS | Aug 20, 2008 | SESE |
| K080811 | TINA-QUANT CYSTATIN C, CALIBRATOR F.A.S. CYSTATIN C AND CYSTATIN C ANDCYSTATIN C CONTROL SET | Roche Diagnostics Corp. | Jun 20, 2008 | SESE |
| K080384 | HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER | The Binding Site, Ltd. | Jun 6, 2008 | SESE |
| K080662 | GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR | Genzyme Corporation | May 15, 2008 | SESE |
| K072270 | DIAZYME CYSTATIN C: ASSAY KIT (DZ133A-K), CALIBRATOR (DZ133A-CAL), CONTROLS (DZ133A-CON) | Diazyme Laboratories | Feb 1, 2008 | SESE |
| K072166 | CYSTATIN C KIT FOR USE ON THE SPAPLUS ANALYZER | The Binding Site | Jan 24, 2008 | SESE |
| K071388 | GENTIAN CYSTATIN C IMMUNOASSAY | Gentian AS | Nov 6, 2007 | SESE |
| K063647 | CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH | Thermo Electron OY | Mar 12, 2007 | SESE |
| K063351 | DIMENSION VISTA CYSC FLEX REAGENT CARTRIDGE, PROTEIN 3 CALIBRATOR AND CYSTATIN CONTROL LOW AND HIGH | Dade Behring, Inc. | Jan 22, 2007 | SESE |
| K041627 | CYSTATIN C IMMUNOPARTICLES, CONTROL SET, CALIBRATOR | Dako A/S | Sep 3, 2004 | SESE |
Top Applicants
- Dade Behring, Inc. — 3 clearances
- Diazyme Laboratories — 3 clearances
- Gentian AS — 2 clearances
- Dako A/S — 1 clearance
- Genzyme Corporation — 1 clearance
