Cleared Traditional

K100101 - GSP NEONATALGALT KIT, MODEL 3303-001U (FDA 510(k) Clearance)

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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.