Cleared Traditional

K062105 - DIAZYME CREATININE LIQUID REAGENTS ASSAY

K062105 is an FDA 510(k) clearance for DIAZYME CREATININE LIQUID REAGENTS ASSAY, manufactured by Diazyme Laboratories. The device is a Class 2 Chemistry device with product code JFY cleared through the Traditional 510(k) pathway after a 273-day FDA review.

K062105 · Diazyme Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2007
Decision
273d
Days
Class 2
Risk

K062105 is an FDA 510(k) clearance for the DIAZYME CREATININE LIQUID REAGENTS ASSAY. Classified as Enzymatic Method, Creatinine (product code JFY), Class II - Special Controls.

Submitted by Diazyme Laboratories (San Diego, US). The FDA issued a Cleared decision on April 23, 2007 after a review of 273 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 - K062105

510(k) Number K062105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2006
Decision Date April 23, 2007
Days to Decision 273 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
185d slower than avg
Panel avg: 88d · This submission: 273d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JFY Device Classification - Class 2, Special Controls

Product Code JFY Enzymatic Method, Creatinine
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 - JFY Enzymatic Method, Creatinine

All 34
Devices cleared under the same product code (JFY) and FDA review panel - the closest regulatory comparables to K062105.
ENZYMATIC CREATININE ASSAY (265 SERIES)
K070383 · Diagnostic Chemicals , Ltd. · Jun 2007
VITROS CHEMISTRY PRODUCTS URCR SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2722, 195 7927
K071215 · Ortho-Clinical Diagnostics, Inc. · May 2007
VITROS CHEMISTRY PRODUCTS CRSC SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2721, 195 7927
K071216 · Ortho-Clinical Diagnostics, Inc. · May 2007
WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR
K061775 · Wako Chemicals USA, Inc. · Feb 2007
VITROS CHEMISTRY PRODUCTS CREA SLIDES,MODEL# 6802584, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1,MODEL#1882208
K063591 · Ortho-Clinical Diagnostics, Inc. · Dec 2006
POLY-CHEM CREATININE
K061944 · Polymedco, Inc. · Nov 2006