Cleared Traditional

K171072 - N Latex Cystatin C

Also marketed or referenced as:
N Protein Standard UY

K171072 is an FDA 510(k) clearance for N Latex Cystatin C, manufactured by Siemens Healthcare Diagnostics Products GmbH. The device is a Class 2 Chemistry device with product code NDY cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K171072 · Siemens Healthcare Diagnostics Products GmbH · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2017
Decision
32d
Days
Class 2
Risk

K171072 is an FDA 510(k) clearance for the N Latex Cystatin C. Classified as Test, Cystatin C (product code NDY), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics Products GmbH (Marburg, DE). The FDA issued a Cleared decision on May 12, 2017 after a review of 32 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 Products GmbH devices

FDA 510(k) Submission Details - K171072

510(k) Number K171072 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2017
Decision Date May 12, 2017
Days to Decision 32 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 88d · This submission: 32d
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 13
Devices cleared under the same product code (NDY) and FDA review panel - the closest regulatory comparables to K171072.
Cystatin C
K242585 · SENTINEL CH. SpA · May 2025
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