Cleared Traditional

K080662 - GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR

K080662 is an FDA 510(k) clearance for GENZYME CYSTATIN C REAGENT ANF GENZYME ..., manufactured by Genzyme Corporation. The device is a Class 2 Chemistry device with product code NDY cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K080662 · Genzyme Corporation · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
66d
Days
Class 2
Risk

K080662 is an FDA 510(k) clearance for the GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR. Classified as Test, Cystatin C (product code NDY), Class II - Special Controls.

Submitted by Genzyme Corporation (Framingham, US). The FDA issued a Cleared decision on May 15, 2008 after a review of 66 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 Genzyme Corporation devices

FDA 510(k) Submission Details - K080662

510(k) Number K080662 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2008
Decision Date May 15, 2008
Days to Decision 66 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
22d faster than avg
Panel avg: 88d · This submission: 66d
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 20
Devices cleared under the same product code (NDY) and FDA review panel - the closest regulatory comparables to K080662.
ADVIA CHEMISTRY CYSTATIN C REAGENT, ADVIA CHEMISTRY CYSTATIN C CALIBRATOR, MODELS P/N 04851534, P/N 10376487
K083906 · Siemens Healthcare Diagnostics · Mar 2009
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
CYSTATIN C KIT FOR USE ON THE SPAPLUS ANALYZER
K072166 · The Binding Site · Jan 2008
GENTIAN CYSTATIN C IMMUNOASSAY
K071388 · Gentian AS · Nov 2007