Cleared Traditional

K833911 - URINE THC CANNABINOIDS DIRECT RIA KIT

K833911 is the FDA 510(k) clearance for URINE THC CANNABINOIDS DIRECT RIA KIT by Immunalysis Corporation. It is a Class 2 Toxicology device (product code LAT) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K833911 · Immunalysis Corporation · Toxicology device

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Jan 1984

Decision

71d

Days

Class 2

Risk

K833911 is an FDA 510(k) clearance for the URINE THC CANNABINOIDS DIRECT RIA KIT. Classified as Radioimmunoassay, Cannabinoid(s) (product code LAT), Class II - Special Controls.

Submitted by Immunalysis Corporation (Walker, US). The FDA issued a Cleared decision on January 24, 1984 after a review of 71 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Immunalysis Corporation devices

Submission Details

510(k) Number	K833911 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 14, 1983
Decision Date	January 24, 1984
Days to Decision	71 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	-
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

16d faster than avg

Panel avg: 87d · This submission: 71d

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 13

Devices cleared under the same product code (LAT) and FDA review panel - the closest regulatory comparables to K833911.

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

ORAL THC-CANNABINOIDS DIRECT RIA KIT

K843534 · Immunalysis Corporation · Oct 1984

ORAL THC-CANNABINOIDS DIRECT RIA KIT

K821965 · Immunalysis Corporation · Jul 1982

THC-CANNABINOIDS DIRECT URINE RIA KIT

K820903 · Immunalysis Corporation · May 1982

ABUSCREEN RADIOIMMUNOASSAY FOR CANNABI

K820391 · Hoffmann-La Roche, Inc. · Mar 1982

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K833911

Immunalysis Corporation

Walker, MI · US

Regulatory profile

50 submissions 50 cleared

100% clearance rate · Active in Toxicology

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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