Cleared Traditional

K050283 - CREATININE LIQUICOLOR

K050283 is the FDA 510(k) clearance for CREATININE LIQUICOLOR by Stanbio Laboratory. It is a Class 2 Chemistry device (product code JFY) cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K050283 · Stanbio Laboratory · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2005
Decision
143d
Days
Class 2
Risk

K050283 is an FDA 510(k) clearance for the CREATININE LIQUICOLOR. Classified as Enzymatic Method, Creatinine (product code JFY), Class II - Special Controls.

Submitted by Stanbio Laboratory (Boerne, US). The FDA issued a Cleared decision on June 30, 2005 after a review of 143 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 Stanbio Laboratory devices

Submission Details

510(k) Number K050283 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2005
Decision Date June 30, 2005
Days to Decision 143 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
55d slower than avg
Panel avg: 88d · This submission: 143d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 28
Devices cleared under the same product code (JFY) and FDA review panel - the closest regulatory comparables to K050283.
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
COBAS INTEGRA CREATININE PLUS VER.2 ASSAY
K024098 · Roche Diagnostics Corp. · Dec 2002
CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM
K021428 · Bayer Corp. · Jul 2002
CREATININE PLUS
K003261 · Roche Diagnostics Corp. · Nov 2000