Cleared Traditional

K071388 - GENTIAN CYSTATIN C IMMUNOASSAY

K071388 is an FDA 510(k) clearance for GENTIAN CYSTATIN C IMMUNOASSAY, manufactured by Gentian AS. The device is a Class 2 Chemistry device with product code NDY cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K071388 · Gentian AS · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2007
Decision
172d
Days
Class 2
Risk

K071388 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 November 6, 2007 after a review of 172 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.

FDA 510(k) Submission Details - K071388

510(k) Number K071388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2007
Decision Date November 06, 2007
Days to Decision 172 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
84d slower than avg
Panel avg: 88d · This submission: 172d
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 21
Devices cleared under the same product code (NDY) and FDA review panel - the closest regulatory comparables to K071388.
GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR
K080662 · Genzyme Corporation · May 2008
DIAZYME CYSTATIN C: ASSAY KIT (DZ133A-K), CALIBRATOR (DZ133A-CAL), CONTROLS (DZ133A-CON)
K072270 · Diazyme Laboratories · Feb 2008
CYSTATIN C KIT FOR USE ON THE SPAPLUS ANALYZER
K072166 · The Binding Site · Jan 2008
CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH
K063647 · Thermo Electron OY · Mar 2007
DIMENSION VISTA CYSC FLEX REAGENT CARTRIDGE, PROTEIN 3 CALIBRATOR AND CYSTATIN CONTROL LOW AND HIGH
K063351 · Dade Behring, Inc. · Jan 2007
CYSTATIN C IMMUNOPARTICLES, CONTROL SET, CALIBRATOR
K041627 · Dako A/S · Sep 2004
K071388 · GENTIAN CYSTATIN C IMMUNOASSAY
Download PDF FDA Summary Gentian AS