Not Cleared Post-NSE

DEN170019 - Vitamin D 200M Assay for the Topaz System (FDA 510(k) Clearance)

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

DEN170019 · Ab Sciex, LLC · Chemistry device
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May 2017
Decision
59d
Days
Class 2
Risk

DEN170019 is an FDA 510(k) submission (not cleared) for the Vitamin D 200M Assay for the Topaz System. Classified as 25-oh-vitamin D Mass Spectrometry Test System (product code PSL), Class II - Special Controls.

Submitted by Ab Sciex, LLC (Framingham, US). The FDA issued a Not Cleared (DENG) decision on May 18, 2017 after a review of 59 days.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1840 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Chemistry review framework.

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Submission Details

510(k) Number DEN170019 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received March 20, 2017
Decision Date May 18, 2017
Days to Decision 59 days
Submission Type Post-NSE
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 88d · This submission: 59d
Pathway characteristics

Device Classification

Product Code PSL 25-oh-vitamin D Mass Spectrometry Test System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1840
Definition A 25-oh-vitamin D Mass Spectrometry Test System Is Intended To For Vitro Diagnostic Use In The Quantitative Determination Of Total 25-hydroxyvitamin D (25-oh-d)using Mass Spectrometry.
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.