Cleared Special

GENTIAN CYSTATIN C IMMUNOASSAY (K081875) - FDA 510(k) Clearance

Class II Chemistry device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K081875 · Gentian AS · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2008
Decision
49d
Days
Class 2
Risk

K081875 is an FDA 510(k) clearance for the GENTIAN CYSTATIN C IMMUNOASSAY. Classified as Test, Cystatin C (product code NDY), Class II - Special Controls.

Submitted by Gentian AS (San Diego, US). The FDA issued a Cleared decision on August 20, 2008 after a review of 49 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Gentian AS devices

Submission Details

510(k) Number K081875 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2008
Decision Date August 20, 2008
Days to Decision 49 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 88d · This submission: 49d
Pathway characteristics
Modification to existing cleared device.

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 21
Devices cleared under the same product code (NDY) and FDA review panel - the closest regulatory comparables to K081875.
Cystatin C
K242585 · SENTINEL CH. SpA · May 2025
ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)
K181082 · Siemens Healthcare Diagnostics, Inc. · May 2018
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
N LATEX CYSTATIN C
K003503 · Dade Behring, Inc. · Mar 2001