Cleared Traditional

K932716 - EMIT THC 50/100 NG ASSAY

K932716 is the FDA 510(k) clearance for EMIT THC 50/100 NG ASSAY by Syva Co.. It is a Class 2 Toxicology device (product code LDJ) cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K932716 · Syva Co. · Toxicology device
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Oct 1993
Decision
119d
Days
Class 2
Risk

K932716 is an FDA 510(k) clearance for the EMIT(R) THC 50/100 NG ASSAY. Classified as Enzyme Immunoassay, Cannabinoids (product code LDJ), Class II - Special Controls.

Submitted by Syva Co. (San Jose, US). The FDA issued a Cleared decision on October 1, 1993 after a review of 119 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 Syva Co. devices

Submission Details

510(k) Number K932716 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1993
Decision Date October 01, 1993
Days to Decision 119 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 87d · This submission: 119d
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 85
Devices cleared under the same product code (LDJ) and FDA review panel - the closest regulatory comparables to K932716.
CEDIA DAU MULTI-LEVEL THC ASSAY
K942337 · Microgenics Corp. · Aug 1994
CEDIA DAU MULTI-LEVEL THC ASSAY, HITACHI 911 REAGENT/ AND THE HITACHI 747 REAGENT
K940649 · Microgenics Corp. · May 1994
CEDIA DAU MULTI-LEVEL THC ASSAY
K935591 · Microgenics Corp. · Jan 1994
BIOSITE TRIAGE PANEL FOR DRUGS OF ABUSE(50NG/ML)
K931598 · Biosite Incorporated · May 1993
CANNABINOID EIA TEST
K920311 · Diagnostic Reagents, Inc. · Feb 1992
IL TEST CANNABINOID, 35282
K920418 · Instrumentation Laboratory CO · Feb 1992