Cleared Traditional

Cystatin C (K242585) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 7
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
TINA-QUANT CYSTATIN C, CALIBRATOR F.A.S. CYSTATIN C AND CYSTATIN C ANDCYSTATIN C CONTROL SET
K080811 · Roche Diagnostics Corp. · Jun 2008
HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER
K080384 · The Binding Site, Ltd. · Jun 2008
DIMENSION VISTA CYSC FLEX REAGENT CARTRIDGE, PROTEIN 3 CALIBRATOR AND CYSTATIN CONTROL LOW AND HIGH
K063351 · Dade Behring, Inc. · Jan 2007
N LATEX CYSTATIN
K041878 · Dade Behring, Inc. · Aug 2004