Cleared Traditional

K141265 - ELITECH CLINICAL SYSTEMS ENVOY 500 CK R...

K141265 is the FDA 510(k) clearance for ELITECH CLINICAL SYSTEMS ENVOY 500 CK R... by Elitechgroup. It is a Class 2 Chemistry device (product code JHW) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K141265 · Elitechgroup · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2014
Decision
64d
Days
Class 2
Risk

K141265 is an FDA 510(k) clearance for the ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT. Classified as U.v. Method, Cpk Isoenzymes (product code JHW), Class II - Special Controls.

Submitted by Elitechgroup (Bothell, US). The FDA issued a Cleared decision on July 18, 2014 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1215 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Elitechgroup devices

Submission Details

510(k) Number K141265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2014
Decision Date July 18, 2014
Days to Decision 64 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 88d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JHW U.v. Method, Cpk Isoenzymes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1215
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 - JHW U.v. Method, Cpk Isoenzymes

All 13
Devices cleared under the same product code (JHW) and FDA review panel - the closest regulatory comparables to K141265.
Creatine Kinase-MB
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K944325 · Princeton BioMeditech Corp. · Feb 1995
AXSYM CK-MB
K935924 · Abbott Laboratories · Jun 1994
CARDIO REP CK ISOENZYME KIT - 3310
K931050 · Helena Laboratories · Apr 1993