Cleared Traditional

K132399 - ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITROL I AND ELITROL II, URINE CONTROL BI-LEVEL (FDA 510(k) Clearance)

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K132399 · Elitechgroup · Chemistry device
Jan 2014
Decision
155d
Days
Class 2
Risk

K132399 is an FDA 510(k) clearance for the ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITROL I AND ELITROL I.... Classified as Enzymatic Method, Creatinine (product code JFY), Class II - Special Controls.

Submitted by Elitechgroup (Bothell, US). The FDA issued a Cleared decision on January 3, 2014 after a review of 155 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.

Submission Details

510(k) Number K132399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2013
Decision Date January 03, 2014
Days to Decision 155 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 234d · This submission: 155d
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.