Cleared Traditional

K111664 - DIAZYME CYSTATIN C POC TEST KIT

K111664 is an FDA 510(k) clearance for DIAZYME CYSTATIN C POC TEST KIT, 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 290-day FDA review.

K111664 · Diazyme Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2012
Decision
290d
Days
Class 2
Risk

K111664 is an FDA 510(k) clearance for the DIAZYME CYSTATIN C POC TEST KIT. 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 March 30, 2012 after a review of 290 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 - K111664

510(k) Number K111664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2011
Decision Date March 30, 2012
Days to Decision 290 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
202d slower than avg
Panel avg: 88d · This submission: 290d
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 14
Devices cleared under the same product code (NDY) and FDA review panel - the closest regulatory comparables to K111664.
ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)
K181082 · Siemens Healthcare Diagnostics, Inc. · May 2018
N Latex Cystatin C
K171072 · Siemens Healthcare Diagnostics Products GmbH · May 2017
COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR, CYSTATIN C GEN.2 CONTROL SET
K141143 · Roche Diagnostics · Jul 2014
K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL
K093137 · Kamiya Biomedical Co. · Sep 2010
ST AIA-PACK CYSTATIN C, MODEL 025217
K093960 · Tosoh Bioscience, Inc. · Sep 2010
DIAZYME CYSTATIN C ASSAY
K093680 · Diazyme Laboratories · Apr 2010