Cleared Traditional

K110830 - ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO

Also marketed or referenced as:
ELITECH CLINICAL SYSTEMS ALBUMIN ELITECH CLINICAL SYSTEMS ELICAL 2 ELITECH

K110830 is the FDA 510(k) clearance for ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO by Elitechgroup. It is a Class 2 Chemistry device (product code CIX) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K110830 · Elitechgroup · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Elitechgroup devices

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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 88d · 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.

Regulatory Peers - CIX Bromcresol Green Dye-binding, Albumin

All 69
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K080874 · Medica Corp. · Feb 2009
ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2
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