Cleared Traditional

AVL OMNI ANALYZER (K945915) - FDA 510(k) Clearance

Class I Chemistry device.

K945915 · Avl Scientific Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1995
Decision
124d
Days
Class 1
Risk

K945915 is an FDA 510(k) clearance for the AVL OMNI ANALYZER. Classified as Analyzer, Chemistry (sequential Multiple, Continuous Flow) Clinical Use (product code JJC), Class I - General Controls.

Submitted by Avl Scientific Corp. (Roswell, US). The FDA issued a Cleared decision on April 5, 1995 after a review of 124 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2150 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Avl Scientific Corp. devices

Submission Details

510(k) Number K945915 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1994
Decision Date April 05, 1995
Days to Decision 124 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
36d slower than avg
Panel avg: 88d · This submission: 124d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJC Analyzer, Chemistry (sequential Multiple, Continuous Flow) Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2150
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 - JJC Analyzer, Chemistry (sequential Multiple, Continuous Flow) Clinical Use

Devices cleared under the same product code (JJC) and FDA review panel - the closest regulatory comparables to K945915.
PARAMAX 520, PARAMAX 720 AND PARAMAX 720ZX
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