Cleared Traditional

K970548 - ONE STEP MARIJUANA CARD TEST

K970548 is an FDA 510(k) clearance for ONE STEP MARIJUANA CARD TEST, manufactured by Teco Diagnostics. The device is a Class 2 Toxicology device with product code LDJ cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K970548 · Teco Diagnostics · Toxicology device
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Jul 1997
Decision
141d
Days
Class 2
Risk

K970548 is an FDA 510(k) clearance for the ONE STEP MARIJUANA CARD TEST. Classified as Enzyme Immunoassay, Cannabinoids (product code LDJ), Class II - Special Controls.

Submitted by Teco Diagnostics (Anaheim, US). The FDA issued a Cleared decision on July 3, 1997 after a review of 141 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 Teco Diagnostics devices

FDA 510(k) Submission Details - K970548

510(k) Number K970548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1997
Decision Date July 03, 1997
Days to Decision 141 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
54d slower than avg
Panel avg: 87d · This submission: 141d
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 99
Devices cleared under the same product code (LDJ) and FDA review panel - the closest regulatory comparables to K970548.
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
QUICKSCREEN ONE STEP THC SCREENING TEST
K973122 · Phamatech · Sep 1997
IMMULITE CANNABINOIDS
K963916 · Diagnostic Products Corp. · Apr 1997
QUIKSTRIP ONESTEP MARIJUANA (THC) TEST
K963654 · Syntron Bioresearch, Inc. · Feb 1997
SYNCHRON SYSTEMS CANNABINOID 20 NG REAGENT
K955677 · Beckman Instruments, Inc. · Apr 1996