Test, Cystatin C
The Test, Cystatin C (product code NDY) is an in vitro diagnostic test used to measure serum cystatin C levels, a marker of kidney function that provides an alternative to creatinine for estimating glomerular filtration rate. It is classified as an FDA Class 2 device within the Clinical Chemistry specialty, requiring 510(k) premarket clearance. No specific regulation number has been assigned to this product code. The device is not flagged as an implant or life-sustaining device.
Basic Information
- Product Code
- NDY
- Device Class
- FDA class 2
- Regulation Number
- 862.1225
- 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 22 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K242585 | Cystatin C | May 16, 2025 | Substantially Equivalent | Sentinel CH. S.p.A. |
| K181082 | ADVIA Chemistry Cystatin C_2 Assay (CYSC_2) | May 25, 2018 | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. |
| K171072 | N Latex Cystatin C; N Protein Standard UY | May 12, 2017 | Substantially Equivalent | Siemens Healthcare Diagnostics Products GmbH |
| K161817 | Tina-quant Cystatin C Gen.2 | Jul 27, 2016 | Substantially Equivalent | Roche Diagnostics Operations (RDO) |
| K141143 | COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR, CYSTATIN C GEN.2 CONTROL SET | Jul 17, 2014 | Substantially Equivalent | Roche Diagnostics |
| K111664 | DIAZYME CYSTATIN C POC TEST KIT | Mar 30, 2012 | Substantially Equivalent | DIAZYME LABORATORIES |
| K093137 | K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL | Sep 28, 2010 | Substantially Equivalent | KAMIYA BIOMEDICAL CO. |
| K093960 | ST AIA-PACK CYSTATIN C, MODEL 025217 | Sep 14, 2010 | Substantially Equivalent | Tosoh BioScience, Inc. |
| K093680 | DIAZYME CYSTATIN C ASSAY | Apr 08, 2010 | Substantially Equivalent | DIAZYME LABORATORIES |
| K083906 | ADVIA CHEMISTRY CYSTATIN C REAGENT, ADVIA CHEMISTRY CYSTATIN C CALIBRATOR, MODELS P/N 04851534, P/N 10376487 | Mar 11, 2009 | Substantially Equivalent | SIEMENS HEALTHCARE DIAGNOSTICS |
| K081875 | GENTIAN CYSTATIN C IMMUNOASSAY | Aug 20, 2008 | Substantially Equivalent | GENTIAN AS |
| K080811 | TINA-QUANT CYSTATIN C, CALIBRATOR F.A.S. CYSTATIN C AND CYSTATIN C ANDCYSTATIN C CONTROL SET | Jun 20, 2008 | Substantially Equivalent | ROCHE DIAGNOSTICS CORP. |
| K080384 | HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER | Jun 06, 2008 | Substantially Equivalent | THE BINDING SITE, LTD. |
| K080662 | GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR | May 15, 2008 | Substantially Equivalent | GENZYME CORPORATION |
| K072270 | DIAZYME CYSTATIN C: ASSAY KIT (DZ133A-K), CALIBRATOR (DZ133A-CAL), CONTROLS (DZ133A-CON) | Feb 01, 2008 | Substantially Equivalent | DIAZYME LABORATORIES |
| K072166 | CYSTATIN C KIT FOR USE ON THE SPAPLUS ANALYZER | Jan 24, 2008 | Substantially Equivalent | THE BINDING SITE |
| K071388 | GENTIAN CYSTATIN C IMMUNOASSAY | Nov 06, 2007 | Substantially Equivalent | GENTIAN AS |
| K063647 | CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH | Mar 12, 2007 | Substantially Equivalent | THERMO ELECTRON OY |
| K063351 | DIMENSION VISTA CYSC FLEX REAGENT CARTRIDGE, PROTEIN 3 CALIBRATOR AND CYSTATIN CONTROL LOW AND HIGH | Jan 22, 2007 | Substantially Equivalent | DADE BEHRING, INC. |
| K041627 | CYSTATIN C IMMUNOPARTICLES, CONTROL SET, CALIBRATOR | Sep 03, 2004 | Substantially Equivalent | DAKO A/S |
| K041878 | N LATEX CYSTATIN | Aug 16, 2004 | Substantially Equivalent | DADE BEHRING, INC. |
| K003503 | N LATEX CYSTATIN C | Mar 13, 2001 | Substantially Equivalent | DADE BEHRING, INC. |
FEI Numbers
This FDA classification entry is associated with 23 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 23 registration numbers. Click on an entry to view related FDA registrations.