Cleared Traditional

K102419 - GSP NEONATAL IRT KIT (3306-001U)

K102419 is an FDA 510(k) clearance for GSP NEONATAL IRT KIT (3306-001U), manufactured by Wallac Oy, Subsidiary of Perkinelmer. The device is a Class 1 Chemistry device with product code JNO cleared through the Traditional 510(k) pathway after a 113-day FDA review.

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

FDA 510(k) Submission Details - K102419

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.

JNO Device Classification - Class 1, General Controls

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.