Cleared Traditional

K980836 - GENIE CUP INTEGRATED SCREENING DEVICE

K980836 is an FDA 510(k) clearance for GENIE CUP INTEGRATED SCREENING DEVICE, manufactured by Applied Technology Ventures, LLC. The device is a Class 2 Toxicology device with 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

FDA 510(k) Submission Details - K980836

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
Combination Product No
PCCP Authorized No
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.

LDJ Device Classification - Class 2, Special Controls

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 124
Devices cleared under the same product code (LDJ) and FDA review panel - the closest regulatory comparables to K980836.
MODIFICATION TO ABUSCREEN ONLINE FOR CANNABINOIDS
K983701 · Roche Diagnostic Systems, Inc. · Dec 1998
DBEST TETRAHYDROCANNABINOL TEST KIT
K983188 · Ameritek, Inc. · Nov 1998
UBI MAGIWEL MARIJUANA METABOLITES
K973154 · United Biotech, Inc. · Jul 1998
ABUSCREEN ONLINE FOR CANNABINOIDS (100 TEST KIT)
K981584 · Roche Diagnostic Systems, Inc. · May 1998
ABUSCREEN ONLINE FOR CANNABINOIDS (1000 TEST KIT)
K981585 · Roche Diagnostic Systems, Inc. · May 1998
STC CANNABINOIDS MICRO-PLATE EIA
K973750 · OraSure Technologies, Inc. · Feb 1998