Cleared Traditional

K925586 - DETECTABUSE(TM)

K925586 is the FDA 510(k) clearance for DETECTABUSE(TM) by Biochemical Diagnostic, Inc.. It is a Class 1 Toxicology device (product code DIF) cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K925586 · Biochemical Diagnostic, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1992
Decision
54d
Days
Class 1
Risk

K925586 is an FDA 510(k) clearance for the DETECTABUSE(TM). Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Biochemical Diagnostic, Inc. (Edgewood, US). The FDA issued a Cleared decision on December 28, 1992 after a review of 54 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3280 - 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 Biochemical Diagnostic, Inc. devices

Submission Details

510(k) Number K925586 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1992
Decision Date December 28, 1992
Days to Decision 54 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 87d · This submission: 54d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DIF Drug Mixture Control Materials
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.3280
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - DIF Drug Mixture Control Materials

All 127
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K925586.
ABUSCREEN ONLINE CONTROL
K931125 · Roche Diagnostic Systems, Inc. · Aug 1993
LYPHOCHEK(R) URINE TOXICOLOGY SCREEN-LOW CONTROL
K932643 · Bio-Rad · Jul 1993
COBAS-FP TDM CONTROLS
K930269 · Roche Diagnostic Systems, Inc. · Feb 1993
DRUG OF ABUSE URINE CONTROL
K920477 · Diagnostic Reagents, Inc. · Mar 1992
LIQUICHEK THERAPEUTIC DRUG MONITORING CONTROL(TDM)
K914170 · Bio-Rad · Nov 1991
ABUSCREEN(R) ONTRAK(R) POSITIVE REFERENCE CONTROL
K914806 · Roche Diagnostic Systems, Inc. · Nov 1991