Cleared Traditional

K190335 - GSP Neonatal Total Galactose kit (FDA 510(k) Clearance)

Class I Chemistry device.

K190335 · Perkinelmer, Inc. · Chemistry device
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Nov 2019
Decision
265d
Days
Class 1
Risk

K190335 is an FDA 510(k) clearance for the GSP Neonatal Total Galactose kit. Classified as Enzymatic Methods, Galactose (product code JIA), Class I - General Controls.

Submitted by Perkinelmer, Inc. (Waltham, US). The FDA issued a Cleared decision on November 6, 2019 after a review of 265 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1310 - 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 K190335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2019
Decision Date November 06, 2019
Days to Decision 265 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
177d slower than avg
Panel avg: 88d · This submission: 265d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JIA Enzymatic Methods, Galactose
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1310
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.