Cleared Traditional

K110830 - ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO (FDA 510(k) Clearance)

Also includes:
ELITECH CLINICAL SYSTEMS ALBUMIN ELITECH CLINICAL SYSTEMS ELICAL 2 ELITECH

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

K110830 · Elitechgroup · Chemistry device
Jun 2011
Decision
88d
Days
Class 2
Risk

K110830 is an FDA 510(k) clearance for the ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO. Classified as Bromcresol Green Dye-binding, Albumin (product code CIX), Class II - Special Controls.

Submitted by Elitechgroup (Bothell, US). The FDA issued a Cleared decision on June 21, 2011 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1035 - 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.

Submission Details

510(k) Number K110830 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2011
Decision Date June 21, 2011
Days to Decision 88 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
146d faster than avg
Panel avg: 234d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CIX Bromcresol Green Dye-binding, Albumin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1035
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.