Cleared Traditional

K913335 - ABUSCREEN ONLINE(TM) CALIBRATORS

K913335 is the FDA 510(k) clearance for ABUSCREEN ONLINE(TM) CALIBRATORS by Roche Diagnostic Systems, Inc.. It is a Class 2 Toxicology device (product code DKB) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K913335 · Roche Diagnostic Systems, Inc. · Toxicology device
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Aug 1991
Decision
34d
Days
Class 2
Risk

K913335 is an FDA 510(k) clearance for the ABUSCREEN(R) ONLINE(TM) CALIBRATORS. Classified as Calibrators, Drug Mixture (product code DKB), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Montclair, US). The FDA issued a Cleared decision on August 26, 1991 after a review of 34 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 K913335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1991
Decision Date August 26, 1991
Days to Decision 34 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
53d faster than avg
Panel avg: 87d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DKB Calibrators, Drug Mixture
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 - DKB Calibrators, Drug Mixture

All 75
Devices cleared under the same product code (DKB) and FDA review panel - the closest regulatory comparables to K913335.
IL TEST(TM) DAT CAL/CONTROL SET B
K913740 · Instrumentation Laboratory CO · Oct 1991
IL TEST(TM) DAT CAL/CONTROL SET C
K913741 · Instrumentation Laboratory CO · Oct 1991
IL TEST(TM) DAT CALIBRATOR A( -)
K913739 · Instrumentation Laboratory CO · Sep 1991
EMIT CALIBRATOR B LEVEL 1(CUTOFF) & LEVEL 2(HIGH)
K912729 · Syva Co. · Jul 1991
ABUSCREEN ONLINE CANNABINOIDS CALIBRATORS
K910085 · Roche Diagnostic Systems, Inc. · Mar 1991
ABUSCREEN(R) ONLINE CALIBRATORS
K905828 · Roche Diagnostic Systems, Inc. · Feb 1991