Cleared Traditional

K041627 - CYSTATIN C IMMUNOPARTICLES, CONTROL SET, CALIBRATOR

K041627 is an FDA 510(k) clearance for CYSTATIN C IMMUNOPARTICLES, manufactured by Dako A/S. The device is a Class 2 Chemistry device with product code NDY cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K041627 · Dako A/S · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2004
Decision
79d
Days
Class 2
Risk

K041627 is an FDA 510(k) clearance for the CYSTATIN C IMMUNOPARTICLES, CONTROL SET, CALIBRATOR. Classified as Test, Cystatin C (product code NDY), Class II - Special Controls.

Submitted by Dako A/S (Glostrup, DK). The FDA issued a Cleared decision on September 3, 2004 after a review of 79 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 Dako A/S devices

FDA 510(k) Submission Details - K041627

510(k) Number K041627 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2004
Decision Date September 03, 2004
Days to Decision 79 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
9d faster than avg
Panel avg: 88d · This submission: 79d
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 15
Devices cleared under the same product code (NDY) and FDA review panel - the closest regulatory comparables to K041627.
HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER
K080384 · The Binding Site, Ltd. · Jun 2008
DIAZYME CYSTATIN C: ASSAY KIT (DZ133A-K), CALIBRATOR (DZ133A-CAL), CONTROLS (DZ133A-CON)
K072270 · Diazyme Laboratories · Feb 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
N LATEX CYSTATIN C
K003503 · Dade Behring, Inc. · Mar 2001