Cleared Traditional

K063647 - CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH

K063647 is an FDA 510(k) clearance for CYSTATIN C ANTISERUM, manufactured by Thermo Electron OY. The device is a Class 2 Chemistry device with product code NDY cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K063647 · Thermo Electron OY · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
95d
Days
Class 2
Risk

K063647 is an FDA 510(k) clearance for the CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH. Classified as Test, Cystatin C (product code NDY), Class II - Special Controls.

Submitted by Thermo Electron OY (Vantaa, FI). The FDA issued a Cleared decision on March 12, 2007 after a review of 95 days - within the typical 510(k) review window.

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.

View all Thermo Electron OY devices

FDA 510(k) Submission Details - K063647

510(k) Number K063647 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2006
Decision Date March 12, 2007
Days to Decision 95 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
7d slower than avg
Panel avg: 88d · This submission: 95d
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 17
Devices cleared under the same product code (NDY) and FDA review panel - the closest regulatory comparables to K063647.
TINA-QUANT CYSTATIN C, CALIBRATOR F.A.S. CYSTATIN C AND CYSTATIN C ANDCYSTATIN C CONTROL SET
K080811 · Roche Diagnostics Corp. · Jun 2008
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
CYSTATIN C IMMUNOPARTICLES, CONTROL SET, CALIBRATOR
K041627 · Dako A/S · Sep 2004
N LATEX CYSTATIN
K041878 · Dade Behring, Inc. · Aug 2004