Not Cleared Direct

DEN180056 - GSP Neonatal Creatine Kinase - MM kit (FDA 510(k) Clearance)

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

DEN180056 · Perkinelmer, Inc. · Chemistry device
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Dec 2019
Decision
427d
Days
Class 2
Risk

DEN180056 is an FDA 510(k) submission (not cleared) for the GSP Neonatal Creatine Kinase - MM kit. Classified as Muscular Dystrophy Newborn Screening Test (product code QJE), Class II - Special Controls.

Submitted by Perkinelmer, Inc. (Waltham, US). The FDA issued a Not Cleared (DENG) decision on December 12, 2019 after a review of 427 days.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1506 - the FDA in vitro diagnostics and chemistry 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. High predicate equivalence gap. With 427 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.

View all Perkinelmer, Inc. devices

Submission Details

510(k) Number DEN180056 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received October 11, 2018
Decision Date December 12, 2019
Days to Decision 427 days
Submission Type Direct
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
339d slower than avg
Panel avg: 88d · This submission: 427d
Pathway characteristics

Device Classification

Product Code QJE Muscular Dystrophy Newborn Screening Test
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1506
Definition A Muscular Dystrophy Newborn Screening Test Is Intended To Measure Creatine Kinase Levels Obtained From Dried Blood Spot Specimens On Filter Paper From Newborns As An Aid In Screening Newborns For Muscular Dystrophy.
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.