Cleared Special

MODIFICATION TO SCOOPER DRUG/ADULTERATION TEST CUP (K013124) - FDA 510(k) Clearance

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

K013124 · Branan Medical Corp. · Toxicology device
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Nov 2001
Decision
49d
Days
Class 2
Risk

K013124 is an FDA 510(k) clearance for the MODIFICATION TO SCOOPER DRUG/ADULTERATION TEST CUP. Classified as Fluorometry, Morphine (product code DJJ), Class II - Special Controls.

Submitted by Branan Medical Corp. (Irvine, US). The FDA issued a Cleared decision on November 7, 2001 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3640 - the FDA toxicology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Branan Medical Corp. devices

Submission Details

510(k) Number K013124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2001
Decision Date November 07, 2001
Days to Decision 49 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 87d · This submission: 49d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DJJ Fluorometry, Morphine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3640
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.