Not Cleared Direct

DEN140010 - PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM (FDA 510(k) Clearance)

Class II Pathology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN140010 · Wallac OY · Pathology device
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Dec 2014
Decision
299d
Days
Class 2
Risk

DEN140010 is an FDA 510(k) submission (not cleared) for the PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM. Classified as Severe Combined Immunodeficiency Disorder (scid) Newborn Screening Test System (product code PJI), Class II - Special Controls.

Submitted by Wallac OY (Waltham, US). The FDA issued a Not Cleared (DENG) decision on December 15, 2014 after a review of 299 days.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 866.5930 - the FDA pathology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. Elevated predicate reliance profile. With 299 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

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Submission Details

510(k) Number DEN140010 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received February 19, 2014
Decision Date December 15, 2014
Days to Decision 299 days
Submission Type Direct
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
222d slower than avg
Panel avg: 77d · This submission: 299d
Pathway characteristics

Device Classification

Product Code PJI Severe Combined Immunodeficiency Disorder (scid) Newborn Screening Test System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5930
Definition A Newborn Screening Test For Severe Combined Immunodeficiency (scid) Intended For The Detection Of T-cell Receptor Excision Circle (trec) Genomic Dna Isolated From Newborn Blood Specimens Dried On Filter Paper. It Is Intended As An Aid In Screening Newborns For Severe Combined Immunodeficiency (scid).
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 Pathology devices follow this clearance model.