Cleared Traditional

K781048 - THC DIRECT RIA KIT

K781048 is an FDA 510(k) clearance for THC DIRECT RIA KIT, manufactured by Immunalysis Corporation. The device is a Class 2 Toxicology device with product code LAT cleared through the Traditional 510(k) pathway after a 104-day FDA review.

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

FDA 510(k) Submission Details - K781048

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
Combination Product No
PCCP Authorized No
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.

LAT Device Classification - Class 2, Special Controls

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.