Cleared Traditional

K980836 - GENIE CUP INTEGRATED SCREENING DEVICE

K980836 is the FDA 510(k) clearance for GENIE CUP INTEGRATED SCREENING DEVICE by Applied Technology Ventures, LLC. It is a Class 2 Toxicology device (product code LDJ) cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K980836 · Applied Technology Ventures, LLC · Toxicology device
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Jun 1998
Decision
117d
Days
Class 2
Risk

K980836 is an FDA 510(k) clearance for the GENIE CUP INTEGRATED SCREENING DEVICE. Classified as Enzyme Immunoassay, Cannabinoids (product code LDJ), Class II - Special Controls.

Submitted by Applied Technology Ventures, LLC (Rockville, US). The FDA issued a Cleared decision on June 29, 1998 after a review of 117 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 Applied Technology Ventures, LLC devices

Submission Details

510(k) Number K980836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1998
Decision Date June 29, 1998
Days to Decision 117 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 87d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LDJ Enzyme Immunoassay, Cannabinoids
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 - LDJ Enzyme Immunoassay, Cannabinoids

All 86
Devices cleared under the same product code (LDJ) and FDA review panel - the closest regulatory comparables to K980836.
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