Not Cleared Direct

DEN150035 - SEEKER System (FDA 510(k) Clearance)

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

DEN150035 · Baebies, Inc. · Chemistry device
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Feb 2017
Decision
548d
Days
Class 2
Risk

DEN150035 is an FDA 510(k) submission (not cleared) for the SEEKER System. Classified as Alpha-d-galactosidase A (gla) Newborn Screening Test System (product code PQW), Class II - Special Controls.

Submitted by Baebies, Inc. (Durham, US). The FDA issued a Not Cleared (DENG) decision on February 3, 2017 after a review of 548 days.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1488 - 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 548 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 Baebies, Inc. devices

Submission Details

510(k) Number DEN150035 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received August 05, 2015
Decision Date February 03, 2017
Days to Decision 548 days
Submission Type Direct
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
460d slower than avg
Panel avg: 88d · This submission: 548d
Pathway characteristics

Device Classification

Product Code PQW Alpha-d-galactosidase A (gla) Newborn Screening Test System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1488
Definition For Quantitative Measurement Of The Activity Of Alpha-d-galactosidase A (gla) From Newborn Dried Blood Spot Specimens.
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.