Cleared Traditional

K110274 - AUTODELFIA NEONATAL IRT KIT (FDA 510(k) Clearance)

Class I Chemistry device.

K110274 · Wallac Oy, A Subsidiary of Perkinelmer, Inc. · Chemistry device
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Jun 2011
Decision
130d
Days
Class 1
Risk

K110274 is an FDA 510(k) clearance for the AUTODELFIA NEONATAL IRT KIT. Classified as N-benzoyl-l-arginine Ethyl Ester (u.v.), Trypsin (product code JNO), Class I - General Controls.

Submitted by Wallac Oy, A Subsidiary of Perkinelmer, Inc. (Waltham, US). The FDA issued a Cleared decision on June 10, 2011 after a review of 130 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1725 - 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 Wallac Oy, A Subsidiary of Perkinelmer, Inc. devices

Submission Details

510(k) Number K110274 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2011
Decision Date June 10, 2011
Days to Decision 130 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
42d slower than avg
Panel avg: 88d · This submission: 130d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JNO N-benzoyl-l-arginine Ethyl Ester (u.v.), Trypsin
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1725
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.