Cleared Traditional

K991516 - MICRO-STRIP FOR MARIJUANA METABOLITES

K991516 is an FDA 510(k) clearance for MICRO-STRIP FOR MARIJUANA METABOLITES, manufactured by Microdiagnostics, Inc.. The device is a Class 2 Toxicology device with 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

FDA 510(k) Submission Details - K991516

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
Combination Product No
PCCP Authorized No
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.

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 K991516.
AT HOME DRUG TEST, MODEL 9078
K994220 · Phamatech · Dec 1999
SCREENERS MARIJUANA TEST, DRUGSCREEN DIP MARIJUANA TEST
K992949 · Drug Detection Devices, Ltd. · Dec 1999
RAPID DRUG SCREEN 5-PANEL DRUG SCREENING TEST FOR COCAINE, MARIJUANA, OPIATES, AMPHETAMINE AND METHAMPHETAMINE
K993796 · American Bio Medica Corp. · Dec 1999
RAPIDONE - MARIJUANA TEST
K990818 · American Bio Medica Corp. · Jul 1999
REDI-TEST THC
K990870 · Redwood Biotech, Inc. · Apr 1999
MODIFICATION TO ABUSCREEN ONLINE FOR CANNABINOIDS
K983701 · Roche Diagnostic Systems, Inc. · Dec 1998