Cleared Traditional

K991516 - MICRO-STRIP FOR MARIJUANA METABOLITES

K991516 is the FDA 510(k) clearance for MICRO-STRIP FOR MARIJUANA METABOLITES by Microdiagnostics, Inc.. It is a Class 2 Toxicology device (product code LDJ) cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K991516 · Microdiagnostics, Inc. · Toxicology device
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Aug 1999
Decision
97d
Days
Class 2
Risk

K991516 is an FDA 510(k) clearance for the MICRO-STRIP FOR MARIJUANA METABOLITES. Classified as Enzyme Immunoassay, Cannabinoids (product code LDJ), Class II - Special Controls.

Submitted by Microdiagnostics, Inc. (Laguna Niguel, US). The FDA issued a Cleared decision on August 5, 1999 after a review of 97 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 Microdiagnostics, Inc. devices

Submission Details

510(k) Number K991516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1999
Decision Date August 05, 1999
Days to Decision 97 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
10d slower than avg
Panel avg: 87d · This submission: 97d
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 K991516.
QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9153 PAT04
K000131 · Phamatech · Feb 2000
SYVA EMIT II PLUS CANNABINOID ASSAY, MODELS 9N029UL/9N129UL
K993984 · Syva Co. · Jan 2000
AT HOME DRUG TEST, MODEL 9078
K994220 · Phamatech · Dec 1999
MODIFICATION TO ABUSCREEN ONLINE FOR CANNABINOIDS
K983701 · Roche Diagnostic Systems, Inc. · Dec 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