Test, Cystatin C
FDA product code NDY · Class II (moderate risk) · 21 CFR 862.1225 · Clinical Chemistry
22510(k) clearances
0PMA approvals
4recalls
Manufacturers
- Dade Behring, Inc. 3
- Diazyme Laboratories 3
- Gentian AS 2
- The Binding Site, Ltd. 2
- Roche Diagnostics Corp. 2
- Siemens Healthcare Diagnostics, Inc. 2
- Dako A/S 1
- Thermo Electron OY 1
- Genzyme Corp. 1
- Tosoh Bioscience Inc 1
- Kamiya Biomedical Co. 1
- Roche Diagnostics Operations (Rdo) 1
- Siemens Healthcare Diagnostics Products GmbH 1
- SENTINEL CH. SpA 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242585 | Cystatin CNDY · Traditional | SENTINEL CH. SpA | 05/16/2025SE |
| K181082 | ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)NDY · Traditional | Siemens Healthcare Diagnostics, Inc. | 05/25/2018SE |
| K171072 | N Latex Cystatin C; N Protein Standard UYNDY · Traditional | Siemens Healthcare Diagnostics Products GmbH | 05/12/2017SE |
| K161817 | Tina-quant Cystatin C Gen.2NDY · Special | Roche Diagnostics Operations (Rdo) | 07/27/2016SE |
| K141143 | Cobas C Tina-Quant Cystatin C GEN.2 Assay, C.F.A.S. Cystatin C Calibrator, Cystatin C…NDY · Traditional | Roche Diagnostics | 07/17/2014SE |
| K111664 | Diazyme Cystatin C Poc Test KitNDY · Traditional | Diazyme Laboratories | 03/30/2012SE |
| K093137 | K-Assay Cystatin C Reagent, Calibrator and ControlNDY · Traditional | Kamiya Biomedical Co. | 09/28/2010SE |
| K093960 | ST Aia-Pack Cystatin C, Model 025217NDY · Traditional | Tosoh Bioscience, Inc. | 09/14/2010SE |
| K093680 | Diazyme Cystatin C AssayNDY · Traditional | Diazyme Laboratories | 04/08/2010SE |
| K083906 | Advia Chemistry Cystatin C Reagent, Advia Chemistry Cystatin C Calibrator, Models P/N…NDY · Traditional | Siemens Healthcare Diagnostics | 03/11/2009SE |
| K081875 | Gentian Cystatin C ImmunoassayNDY · Special | Gentian AS | 08/20/2008SE |
| K080811 | Tina-Quant Cystatin C, Calibrator F.A.S. Cystatin C and Cystatin C Andcystatin C Control…NDY · Traditional | Roche Diagnostics Corp. | 06/20/2008SE |
| K080384 | Human Cystatin C Kit for Use on Modular P AnalyserNDY · Traditional | The Binding Site, Ltd. | 06/06/2008SE |
| K080662 | Genzyme Cystatin C Reagent Anf Genzyme Cystatin C CalibratorNDY · Traditional | Genzyme Corporation | 05/15/2008SE |
| K072270 | Diazyme Cystatin C: Assay Kit (DZ133A-K), Calibrator (DZ133A-CAL), Controls (DZ133A-CON)NDY · Traditional | Diazyme Laboratories | 02/01/2008SE |
| K072166 | Cystatin C Kit for Use on the Spaplus AnalyzerNDY · Traditional | The Binding Site | 01/24/2008SE |
| K071388 | Gentian Cystatin C ImmunoassayNDY · Traditional | Gentian AS | 11/06/2007SE |
| K063647 | Cystatin C Antiserum, Calibrator, Control and Control HighNDY · Traditional | Thermo Electron OY | 03/12/2007SE |
| K063351 | Dimension Vista Cysc Flex Reagent Cartridge, Protein 3 Calibrator and Cystatin Control…NDY · Traditional | Dade Behring, Inc. | 01/22/2007SE |
| K041627 | Cystatin C Immunoparticles, Control Set, CalibratorNDY · Traditional | Dako A/S | 09/03/2004SE |
| K041878 | N Latex CystatinNDY · Traditional | Dade Behring, Inc. | 08/16/2004SE |
| K003503 | N Latex Cystatin CNDY · Traditional | Dade Behring, Inc. | 03/13/2001SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2425-2024 Class II | RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox…Cystatin C Reagent marketed without a 510 (k) | Randox Laboratories Ltd. | 06/07/2024Open, Classified |
| Z-1369-2024 Class II | Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox…Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods | Randox Laboratories Ltd. | 02/14/2024Open, Classified |
| Z-0099-2021 Class II | GENTIAN Cystatin C Calibrator and Calibrator Kit, for the following models: 1. Gentian C…The firm has identified lots of calibrators that have shown to measure incorrect high values over time… | Gentian AS | 09/02/2020Terminated |
| Z-2099-2018 Class II | ST-AIA PACK Cystatin C; Part Number: 025217 Assay, Kidney MarkerAsfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or… | Tosoh Bioscience Inc | 03/05/2018Terminated |