Not Cleared Post-NSE

DEN130005 - QUANTITATION OF ORGANOPHOSPHATE METABOLITES IN URINE BY LC/MS/MS (FDA 510(k) Clearance)

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

DEN130005 · Centers For Disease Control and Prevention · Toxicology device
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Aug 2013
Decision
72d
Days
Class 2
Risk

DEN130005 is an FDA 510(k) submission (not cleared) for the QUANTITATION OF ORGANOPHOSPHATE METABOLITES IN URINE BY LC/MS/MS. Classified as Organophosphate Test System (product code PDY), Class II - Special Controls.

Submitted by Centers For Disease Control and Prevention (Atlanta, US). The FDA issued a Not Cleared (DENG) decision on August 8, 2013 after a review of 72 days.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3652 - the FDA toxicology 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: 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 Toxicology review framework.

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Submission Details

510(k) Number DEN130005 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received May 28, 2013
Decision Date August 08, 2013
Days to Decision 72 days
Submission Type Post-NSE
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 87d · This submission: 72d
Pathway characteristics

Device Classification

Product Code PDY Organophosphate Test System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3652
Definition For The Quantitation Of Specific Organophosphate Metabolites In Human Urine From Individuals Who Have Signs And Symptoms Consistent With Cholinesterase Poisoning. The Data Obtained By This Device Is Intended To Aid In The Confirmation And Investigation Of Organophosphate Exposure.
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 Toxicology devices follow this clearance model.