Cleared Abbreviated

K151552 - ELITech Clinical Systems ELICAL 2

K151552 is the FDA 510(k) clearance for ELITech Clinical Systems ELICAL 2 by Elitechgroup. It is a Class 2 Chemistry device (product code JIX) cleared through the Abbreviated 510(k) pathway after a 29-day FDA review.

K151552 · Elitechgroup · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2015
Decision
29d
Days
Class 2
Risk

K151552 is an FDA 510(k) clearance for the ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITec.... Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Elitechgroup (Sees, FR). The FDA issued a Cleared decision on July 8, 2015 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - the FDA in vitro diagnostics and chemistry framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Elitechgroup devices

Submission Details

510(k) Number K151552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2015
Decision Date July 08, 2015
Days to Decision 29 days
Submission Type Abbreviated
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 88d · This submission: 29d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code JIX Calibrator, Multi-analyte Mixture
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 - JIX Calibrator, Multi-analyte Mixture

All 183
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