Cleared Traditional

K242585 - Cystatin C

K242585 is an FDA 510(k) clearance for Cystatin C, manufactured by SENTINEL CH. SpA. The device is a Class 2 Chemistry device with product code NDY cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K242585 · SENTINEL CH. SpA · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2025
Decision
259d
Days
Class 2
Risk

K242585 is an FDA 510(k) clearance for the Cystatin C. Classified as Test, Cystatin C (product code NDY), Class II - Special Controls.

Submitted by SENTINEL CH. SpA (Milan (Mi), IT). The FDA issued a Cleared decision on May 16, 2025 after a review of 259 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1225 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all SENTINEL CH. SpA devices

FDA 510(k) Submission Details - K242585

510(k) Number K242585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2024
Decision Date May 16, 2025
Days to Decision 259 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
171d slower than avg
Panel avg: 88d · This submission: 259d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NDY Device Classification - Class 2, Special Controls

Product Code NDY Test, Cystatin C
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1225
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - NDY Test, Cystatin C

All 12
Devices cleared under the same product code (NDY) and FDA review panel - the closest regulatory comparables to K242585.
ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)
K181082 · Siemens Healthcare Diagnostics, Inc. · May 2018
COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR, CYSTATIN C GEN.2 CONTROL SET
K141143 · Roche Diagnostics · Jul 2014
DIAZYME CYSTATIN C POC TEST KIT
K111664 · Diazyme Laboratories · Mar 2012
K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL
K093137 · Kamiya Biomedical Co. · Sep 2010
DIAZYME CYSTATIN C ASSAY
K093680 · Diazyme Laboratories · Apr 2010
ADVIA CHEMISTRY CYSTATIN C REAGENT, ADVIA CHEMISTRY CYSTATIN C CALIBRATOR, MODELS P/N 04851534, P/N 10376487
K083906 · Siemens Healthcare Diagnostics · Mar 2009