Cleared Traditional

K181082 - ADVIA Chemistry Cystatin C_2 Assay (CYS...

K181082 is the FDA 510(k) clearance for ADVIA Chemistry Cystatin C_2 Assay (CYS... by Siemens Healthcare Diagnostics, Inc.. It is a Class 2 Chemistry device (product code NDY) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K181082 · Siemens Healthcare Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2018
Decision
31d
Days
Class 2
Risk

K181082 is an FDA 510(k) clearance for the ADVIA Chemistry Cystatin C_2 Assay (CYSC_2). Classified as Test, Cystatin C (product code NDY), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics, Inc. (Newark, US). The FDA issued a Cleared decision on May 25, 2018 after a review of 31 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Siemens Healthcare Diagnostics, Inc. devices

Submission Details

510(k) Number K181082 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2018
Decision Date May 25, 2018
Days to Decision 31 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
57d faster than avg
Panel avg: 88d · This submission: 31d
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 12
Devices cleared under the same product code (NDY) and FDA review panel - the closest regulatory comparables to K181082.
Cystatin C
K242585 · SENTINEL CH. SpA · May 2025
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