Cleared Traditional

K971841 - BIONIKE AQ ONE STEP CANNABINOIDS (THC) TEST

K971841 is an FDA 510(k) clearance for BIONIKE AQ ONE STEP CANNABINOIDS (THC) TEST, manufactured by Bionike Laboratories, Inc.. The device is a Class 2 Toxicology device with product code LDJ cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K971841 · Bionike Laboratories, Inc. · Toxicology device
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Jun 1997
Decision
37d
Days
Class 2
Risk

K971841 is an FDA 510(k) clearance for the BIONIKE AQ ONE STEP CANNABINOIDS (THC) TEST. Classified as Enzyme Immunoassay, Cannabinoids (product code LDJ), Class II - Special Controls.

Submitted by Bionike Laboratories, Inc. (South San Francisco, US). The FDA issued a Cleared decision on June 25, 1997 after a review of 37 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bionike Laboratories, Inc. devices

FDA 510(k) Submission Details - K971841

510(k) Number K971841 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1997
Decision Date June 25, 1997
Days to Decision 37 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
50d faster than avg
Panel avg: 87d · This submission: 37d
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 K971841.
STC CANNABINOIDS MICRO-PLATE EIA
K973750 · OraSure Technologies, Inc. · Feb 1998
QUICKSCREEN ONE STEP THC SCREENING TEST
K973122 · Phamatech · Sep 1997
ONE STEP MARIJUANA CARD TEST
K970548 · Teco Diagnostics · Jul 1997
IMMULITE CANNABINOIDS
K963916 · Diagnostic Products Corp. · Apr 1997
QUIKSTRIP ONESTEP MARIJUANA (THC) TEST
K963654 · Syntron Bioresearch, Inc. · Feb 1997
QUICKPAC II ONE STEP MARIJUANA (THC) TEST
K963207 · Drial Consultants, Inc. · Feb 1997