Cleared Traditional

K946000 - ABUSCREEN ONLINE CALIBRATORS

K946000 is the FDA 510(k) clearance for ABUSCREEN ONLINE CALIBRATORS by Roche Diagnostic Systems, Inc.. It is a Class 2 Toxicology device (product code DKJ) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K946000 · Roche Diagnostic Systems, Inc. · Toxicology device
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Jan 1995
Decision
50d
Days
Class 2
Risk

K946000 is an FDA 510(k) clearance for the ABUSCREEN ONLINE(R) CALIBRATORS. Classified as Colorimetry, Salicylate (product code DKJ), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Somerville, US). The FDA issued a Cleared decision on January 25, 1995 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3830 - 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 K946000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1994
Decision Date January 25, 1995
Days to Decision 50 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
37d faster than avg
Panel avg: 87d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DKJ Colorimetry, Salicylate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3830
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 - DKJ Colorimetry, Salicylate

All 19
Devices cleared under the same product code (DKJ) and FDA review panel - the closest regulatory comparables to K946000.
SALICYLATE ASSAY (ACE), CATALOGUE NUMBER 501-71
K980032 · Diagnostic Chemicals , Ltd. · Mar 1998
SALICYLATE ASSAY
K961131 · Diagnostic Reagents, Inc. · Apr 1996
AXSYM SALICYLATE
K951290 · Abbott Laboratories · Aug 1995
DU PONT DIMENSION(R) SALICYLATE(SAL) METHOD
K904301 · E.I. Dupont DE Nemours & Co., Inc. · Nov 1990
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (SALI)
K902356 · Eastman Kodak Company · Jul 1990
EASY-TEST SALICYLATE (SAL) #16691
K873425 · Em Diagnostic Systems, Inc. · Oct 1987