Tina-quant Cystatin C Gen.2
FDA 510(k) K161817 · Roche Diagnostics Operations (Rdo)
510(k) numberK161817
Submission
- Device name
- Tina-quant Cystatin C Gen.2
- Applicant
- Roche Diagnostics Operations (Rdo)
Indianapolis, IN, US - Received
- July 1, 2016
- Decision date
- July 27, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NDY – Test, Cystatin C
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1225
- Specialty
- Clinical Chemistry
Other 510(k)s with product code NDY
| 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 |
| 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 |
More from Gentian AS
| 510(k) | Device | Decision |
|---|---|---|
| K193053 | Tina-quant Hemoglobin A1cDx Gen.3PDJ · Traditional | 03/26/2020SE |
| K192072 | Tina-quant C-Reactive Protein IVDCN · Traditional | 02/21/2020SE |
| K183517 | Ammonia IIJIF · Traditional | 02/08/2019SE |
| K182095 | Tina-quant Transferrin ver.2 (urine application)DDG · Traditional | 11/05/2018SE |
| K171080 | ALP IFCC Gen.2CJE · Special | 05/10/2017SE |
| K160571 | cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 AssayPDJ · Traditional | 12/19/2016SE |
| K162593 | HDL-Cholesterol Gen.4LBS · Traditional | 10/19/2016SE |
| K160570 | Creatine KinaseJHS · Traditional | 05/25/2016SE |
| K152245 | ONLINE TDM Vancomycin Gen.3LEH · Traditional | 01/08/2016SE |
| K151578 | Carbamazepine Gen 4KLT · Traditional | 10/22/2015SE |
Questions and answers
When was Tina-quant Cystatin C Gen.2 cleared by the FDA?
Tina-quant Cystatin C Gen.2 (K161817) received a 510(k) decision of Substantially Equivalent on July 27, 2016, 26 days after the submission was received.
What is the product code of K161817?
The FDA product code is NDY – Test, Cystatin C, a Class II (moderate risk) device regulated under 21 CFR 862.1225.