Product Code: LAT FDA class 2 21 CFR 862.3870

Radioimmunoassay, Cannabinoid(S)

Clinical Toxicology

Radioimmunoassay for cannabinoids is a laboratory immunoassay method that uses radiolabeled tracers to detect and measure cannabinoid compounds in patient specimens, typically for drug screening or monitoring purposes in clinical toxicology. It is an FDA Class 2 device, requiring 510(k) premarket clearance. The product code is LAT, regulated under 21 CFR 862.3870, in the Clinical Toxicology specialty. Third-party review eligibility applies.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: LAT
Device Class: FDA class 2
Regulation Number: 862.3870
Medical Specialty: Clinical Toxicology
Review Panel: TX
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 16 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K011426	PSYCHEMEDICS RIA CANNABINOID ASSAY	May 03, 2002	Substantially Equivalent	PSYCHEMEDICS CORP.
K961620	ABISCREEN ONLINE FOR CANNABINOIDS - ES 50/100	Jun 13, 1996	Substantially Equivalent	ROCHE DIAGNOSTIC SYSTEMS, INC.
K936135	SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF MARIJUANA IN PERSPIRATION	Jun 10, 1996	Substantially Equivalent	SUDORMED, INC.
K914507	DOUBLE ANTIBODY CANNABIONOIDS/QUAIL DETER IN URINE	Dec 18, 1991	Substantially Equivalent	DIAGNOSTIC PRODUCTS CORP.
K913414	ABUSCREEN(R) ONLINE(TM) FOR THC(50/100)(100TEST KT	Sep 25, 1991	Substantially Equivalent	ROCHE DIAGNOSTIC SYSTEMS, INC.
K913865	URINE THC DIRECT RIA KIT (I-125)	Sep 18, 1991	Substantially Equivalent	Immunalysis Corporation
K912574	ABUSCREEN ONLINE FOR THC (50 AND 100)	Aug 12, 1991	Substantially Equivalent	ROCHE DIAGNOSTIC SYSTEMS, INC.
K904996	ABUSCREEN ONLINE TM FOR THC	Jan 11, 1991	Substantially Equivalent	ROCHE DIAGNOSTIC SYSTEMS, INC.
K843534	ORAL THC-CANNABINOIDS DIRECT RIA KIT	Oct 30, 1984	Substantially Equivalent	Immunalysis Corporation
K833911	URINE THC CANNABINOIDS DIRECT RIA KIT	Jan 24, 1984	Substantially Equivalent	Immunalysis Corporation
K821965	ORAL THC-CANNABINOIDS DIRECT RIA KIT	Jul 20, 1982	Substantially Equivalent	Immunalysis Corporation
K820903	THC-CANNABINOIDS DIRECT URINE RIA KIT	May 05, 1982	Substantially Equivalent	Immunalysis Corporation
K820391	ABUSCREEN RADIOIMMUNOASSAY FOR CANNABI	Mar 08, 1982	Substantially Equivalent	HOFFMANN-LA ROCHE, INC.
K800246	EMIT -D.A.U. CANNABINOID URINE ASSAY	Feb 26, 1980	Substantially Equivalent	SYVA CO.
K791649	TETRAHYDROCANNALBINOL DIRECT BLOOD KIT	Oct 11, 1979	Substantially Equivalent	Immunalysis Corporation
K781048	THC DIRECT RIA KIT	Oct 03, 1978	Substantially Equivalent	Immunalysis Corporation