Cleared Traditional

K072270 - DIAZYME CYSTATIN C: ASSAY KIT (DZ133A-K), CALIBRATOR (DZ133A-CAL), CONTROLS (DZ133A-CON)

K072270 is an FDA 510(k) clearance for DIAZYME CYSTATIN C: ASSAY KIT (DZ133A-K), manufactured by Diazyme Laboratories. The device is a Class 2 Chemistry device with product code NDY cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K072270 · Diazyme Laboratories · Chemistry device
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Feb 2008
Decision
170d
Days
Class 2
Risk

K072270 is an FDA 510(k) clearance for the DIAZYME CYSTATIN C: ASSAY KIT (DZ133A-K), CALIBRATOR (DZ133A-CAL), CONTROLS (.... Classified as Test, Cystatin C (product code NDY), Class II - Special Controls.

Submitted by Diazyme Laboratories (Poway, US). The FDA issued a Cleared decision on February 1, 2008 after a review of 170 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.

View all Diazyme Laboratories devices

FDA 510(k) Submission Details - K072270

510(k) Number K072270 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2007
Decision Date February 01, 2008
Days to Decision 170 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d slower than avg
Panel avg: 88d · This submission: 170d
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 K072270.
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
GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR
K080662 · Genzyme Corporation · May 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
CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH
K063647 · Thermo Electron OY · Mar 2007