Cleared Traditional

THC DIRECT RIA KIT (K781048) - FDA 510(k) Clearance

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

K781048 · Immunalysis Corporation · Toxicology device
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Oct 1978
Decision
104d
Days
Class 2
Risk

K781048 is an FDA 510(k) clearance for the THC DIRECT RIA KIT. Classified as Radioimmunoassay, Cannabinoid(s) (product code LAT), Class II - Special Controls.

Submitted by Immunalysis Corporation (Mchenry, US). The FDA issued a Cleared decision on October 3, 1978 after a review of 104 days - within the typical 510(k) review window.

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

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Immunalysis Corporation devices

Submission Details

510(k) Number K781048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1978
Decision Date October 03, 1978
Days to Decision 104 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 87d · This submission: 104d
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 Toxicology 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 K781048.
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