Cleared Traditional

GSP NEONATAL IRT KIT (3306-001U) (K102419) - FDA 510(k) Clearance

Class I Chemistry device.

K102419 · Wallac Oy, Subsidiary of Perkinelmer · Chemistry device
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Dec 2010
Decision
113d
Days
Class 1
Risk

K102419 is an FDA 510(k) clearance for the GSP NEONATAL IRT KIT (3306-001U). Classified as N-benzoyl-l-arginine Ethyl Ester (u.v.), Trypsin (product code JNO), Class I - General Controls.

Submitted by Wallac Oy, Subsidiary of Perkinelmer (Waltham, US). The FDA issued a Cleared decision on December 16, 2010 after a review of 113 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, Subsidiary of Perkinelmer devices

Submission Details

510(k) Number K102419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2010
Decision Date December 16, 2010
Days to Decision 113 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
25d slower than avg
Panel avg: 88d · This submission: 113d
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.