Cleared Traditional

K820903 - THC-CANNABINOIDS DIRECT URINE RIA KIT

K820903 is the FDA 510(k) clearance for THC-CANNABINOIDS DIRECT URINE RIA KIT by Immunalysis Corporation. It is a Class 2 Toxicology device (product code LAT) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K820903 · Immunalysis Corporation · Toxicology device

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May 1982

Decision

35d

Days

Class 2

Risk

K820903 is an FDA 510(k) clearance for the THC-CANNABINOIDS DIRECT URINE 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 May 5, 1982 after a review of 35 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	K820903 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 31, 1982
Decision Date	May 05, 1982
Days to Decision	35 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

52d faster than avg

Panel avg: 87d · This submission: 35d

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 K820903.

ORAL THC-CANNABINOIDS DIRECT RIA KIT

K843534 · Immunalysis Corporation · Oct 1984

URINE THC CANNABINOIDS DIRECT RIA KIT

K833911 · Immunalysis Corporation · Jan 1984

ORAL THC-CANNABINOIDS DIRECT RIA KIT

K821965 · Immunalysis Corporation · Jul 1982

ABUSCREEN RADIOIMMUNOASSAY FOR CANNABI

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

EMIT -D.A.U. CANNABINOID URINE ASSAY

K800246 · Syva Co. · Feb 1980

TETRAHYDROCANNALBINOL DIRECT BLOOD KIT

K791649 · Immunalysis Corporation · Oct 1979

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 K820903

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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