Cystatin C

FDA 510(k) K242585 · SENTINEL CH. SpA

Substantially Equivalent

510(k) numberK242585

Submission

Device name
Cystatin C
Applicant
SENTINEL CH. SpA
Milan (Mi), IT
Received
August 30, 2024
Decision date
May 16, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

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)DeviceApplicantDecision
K181082ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)NDY · Traditional Siemens Healthcare Diagnostics, Inc.05/25/2018SE
K171072N Latex Cystatin C; N Protein Standard UYNDY · Traditional Siemens Healthcare Diagnostics Products GmbH05/12/2017SE
K161817Tina-quant Cystatin C Gen.2NDY · Special Roche Diagnostics Operations (Rdo)07/27/2016SE
K141143Cobas C Tina-Quant Cystatin C GEN.2 Assay, C.F.A.S. Cystatin C Calibrator, Cystatin C…NDY · Traditional Roche Diagnostics07/17/2014SE
K111664Diazyme Cystatin C Poc Test KitNDY · Traditional Diazyme Laboratories03/30/2012SE
K093137K-Assay Cystatin C Reagent, Calibrator and ControlNDY · Traditional Kamiya Biomedical Co.09/28/2010SE
K093960ST Aia-Pack Cystatin C, Model 025217NDY · Traditional Tosoh Bioscience, Inc.09/14/2010SE
K093680Diazyme Cystatin C AssayNDY · Traditional Diazyme Laboratories04/08/2010SE
K083906Advia Chemistry Cystatin C Reagent, Advia Chemistry Cystatin C Calibrator, Models P/N…NDY · Traditional Siemens Healthcare Diagnostics03/11/2009SE
K081875Gentian Cystatin C ImmunoassayNDY · Special Gentian AS08/20/2008SE

More from Gentian AS

510(k)DeviceDecision
K211058Lp(a) UltraDFC · Traditional 12/22/2022SE
K193001Albumin BCPCJW · Traditional 12/19/2019SE
K192118CRP VarioDCK · Special 11/08/2019SE
K173833CRP VarioNQD · Traditional 09/27/2018SE
K141728Ace CalibratorJIT · Abbreviated 07/28/2014SE
K102706CKMB Udr AssayJHS · Traditional 08/19/2011SE
K083602Kappa Light ChainsDFH · Traditional 09/03/2009SE
K083601Lambda Light ChainsDEH · Traditional 06/22/2009SE
K081533Sentinel Plasmaproteins Cal 3XJIX · Traditional 06/25/2008SE
K073634Multigent Creatinine (Enzymatic) AssayJFY · Traditional 06/19/2008SE

Questions and answers

When was Cystatin C cleared by the FDA?

Cystatin C (K242585) received a 510(k) decision of Substantially Equivalent on May 16, 2025, 259 days after the submission was received.

What is the product code of K242585?

The FDA product code is NDY – Test, Cystatin C, a Class II (moderate risk) device regulated under 21 CFR 862.1225.