Cleared Traditional

K100101 - GSP NEONATALGALT KIT

K100101 is an FDA 510(k) clearance for GSP NEONATALGALT KIT, manufactured by Perkinelmer, Inc.. The device is a Class 2 Chemistry device with product code KQP cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K100101 · Perkinelmer, Inc. · Chemistry device
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Jun 2010
Decision
149d
Days
Class 2
Risk

K100101 is an FDA 510(k) clearance for the GSP NEONATALGALT KIT, MODEL 3303-001U. Classified as Fluorescent Proc. (qual.), Galactose-1-phosphate Uridyl Transferase (product code KQP), Class II - Special Controls.

Submitted by Perkinelmer, Inc. (Indianapolis, US). The FDA issued a Cleared decision on June 11, 2010 after a review of 149 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1315 - 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 Perkinelmer, Inc. devices

FDA 510(k) Submission Details - K100101

510(k) Number K100101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2010
Decision Date June 11, 2010
Days to Decision 149 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
61d slower than avg
Panel avg: 88d · This submission: 149d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KQP Device Classification - Class 2, Special Controls

Product Code KQP Fluorescent Proc. (qual.), Galactose-1-phosphate Uridyl Transferase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1315
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.