Cleared Traditional

K971361 - AQ OPIATES (MORPHINE) TEST

K971361 is the FDA 510(k) clearance for AQ OPIATES (MORPHINE) TEST by Bionike Laboratories, Inc.. It is a Class 2 Toxicology device (product code DJG) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K971361 · Bionike Laboratories, Inc. · Toxicology device
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Jun 1997
Decision
56d
Days
Class 2
Risk

K971361 is an FDA 510(k) clearance for the AQ OPIATES (MORPHINE) TEST. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Bionike Laboratories, Inc. (South San Francisco, US). The FDA issued a Cleared decision on June 6, 1997 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3650 - 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

Submission Details

510(k) Number K971361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1997
Decision Date June 06, 1997
Days to Decision 56 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
31d faster than avg
Panel avg: 87d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DJG Enzyme Immunoassay, Opiates
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3650
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 - DJG Enzyme Immunoassay, Opiates

All 137
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K971361.
ABUSCREEN ONLINE II FOR OPIATES 300/2000, ABUSCREEN ONLINE OPIATES CALIBRATION PACK, ABUSCREEN ONLINE OPIATES CONTROL
K974840 · Roche Diagnostic Systems, Inc. · Apr 1998
QUICKSCREEN ONE STEP OPIATE SCREENING TEST (9080)
K972619 · Phamatech · Aug 1997
EMIT II OPIATES 300/2000 ASSAY
K971596 · Behring Diagnostics, Inc. · Jun 1997
IMMULITE OPIATES SCREEN/CONTROL MODULE
K962323 · Diagnostic Products Corp. · Mar 1997
CEDIA DAU OPIATE 2K ASSAY
K962795 · Boehringer Mannheim Corp. · Oct 1996
FRONTLINE OPIATES
K954498 · Boehringer Mannheim Corp. · Mar 1996