Cleared Traditional

SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF MARIJUANA IN PERSPIRATION (K936135) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K936135 · Sudormed, Inc. · Chemistry device
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Jun 1996
Decision
895d
Days
Class 2
Risk

K936135 is an FDA 510(k) clearance for the SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF MARIJUANA IN PERSPI.... Classified as Radioimmunoassay, Cannabinoid(s) (product code LAT), Class II - Special Controls.

Submitted by Sudormed, Inc. (Santa Ana, US). The FDA issued a Cleared decision on June 10, 1996 after a review of 895 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3870 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Sudormed, Inc. devices

Submission Details

510(k) Number K936135 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1993
Decision Date June 10, 1996
Days to Decision 895 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
807d slower than avg
Panel avg: 88d · This submission: 895d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LAT Radioimmunoassay, Cannabinoid(s)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3870
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.

Regulatory Peers - LAT Radioimmunoassay, Cannabinoid(s)

All 15
Devices cleared under the same product code (LAT) and FDA review panel - the closest regulatory comparables to K936135.
ABISCREEN ONLINE FOR CANNABINOIDS - ES 50/100
K961620 · Roche Diagnostic Systems, Inc. · Jun 1996
DOUBLE ANTIBODY CANNABIONOIDS/QUAIL DETER IN URINE
K914507 · Diagnostic Products Corp. · Dec 1991
ABUSCREEN(R) ONLINE(TM) FOR THC(50/100)(100TEST KT
K913414 · Roche Diagnostic Systems, Inc. · Sep 1991
ABUSCREEN ONLINE FOR THC (50 AND 100)
K912574 · Roche Diagnostic Systems, Inc. · Aug 1991
ABUSCREEN ONLINE TM FOR THC
K904996 · Roche Diagnostic Systems, Inc. · Jan 1991
EMIT -D.A.U. CANNABINOID URINE ASSAY
K800246 · Syva Co. · Feb 1980