Cleared Traditional

K912048 - ABUSCREEN ONLINE(TM) THC CALIBRATORS

K912048 is the FDA 510(k) clearance for ABUSCREEN ONLINE(TM) THC CALIBRATORS by Roche Diagnostic Systems, Inc.. It is a Class 2 Toxicology device (product code DLJ) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K912048 · Roche Diagnostic Systems, Inc. · Toxicology device
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Jul 1991
Decision
78d
Days
Class 2
Risk

K912048 is an FDA 510(k) clearance for the ABUSCREEN(R) ONLINE(TM) THC CALIBRATORS. Classified as Calibrators, Drug Specific (product code DLJ), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Montclair, US). The FDA issued a Cleared decision on July 26, 1991 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3200 - 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 Roche Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K912048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1991
Decision Date July 26, 1991
Days to Decision 78 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
9d faster than avg
Panel avg: 87d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DLJ Calibrators, Drug Specific
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3200
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 - DLJ Calibrators, Drug Specific

All 91
Devices cleared under the same product code (DLJ) and FDA review panel - the closest regulatory comparables to K912048.
THC URINE CALIBRATORS
K923386 · Diagnostic Reagents, Inc. · Sep 1992
THC URINE CALIBRATORS
K920749 · Diagnostic Reagents, Inc. · Mar 1992
DIGITOXIN FPIA CALIBRATOR SET
K915464 · Sigma Diagnostics, Inc. · Jan 1992
ABUSCREEN ONLINE COCAINE METABOLITE CALIBRATORS
K910086 · Roche Diagnostic Systems, Inc. · Jan 1991
EMIT(R) II 9 CANNABINOID NEGATIVE CALIBRA/CONTROLS
K904569 · Syva Co. · Dec 1990
DUPONT SALICYLATE CALIBRATOR
K904307 · E.I. Dupont DE Nemours & Co., Inc. · Nov 1990