Cleared Traditional

ETI-MAX 3000 (K052794) - FDA 510(k) Clearance

Class I Immunology device.

K052794 · DiaSorin, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
179d
Days
Class 1
Risk

K052794 is an FDA 510(k) clearance for the ETI-MAX 3000. Classified as Analyzer, Chemistry, Micro, For Clinical Use (product code JJF), Class I - General Controls.

Submitted by DiaSorin, Inc. (Stillwater, US). The FDA issued a Cleared decision on March 31, 2006 after a review of 179 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.2170 - the FDA immunology device 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 Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all DiaSorin, Inc. devices

Submission Details

510(k) Number K052794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2005
Decision Date March 31, 2006
Days to Decision 179 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 104d · This submission: 179d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJF Analyzer, Chemistry, Micro, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2170
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJF Analyzer, Chemistry, Micro, For Clinical Use

All 56
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