Cleared Traditional

K890883 - ABUSCREEN FP BUFFER REAGENT

K890883 is the FDA 510(k) clearance for ABUSCREEN FP BUFFER REAGENT by Roche Diagnostic Systems, Inc.. It is a Class 2 Toxicology device (product code DIO) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K890883 · Roche Diagnostic Systems, Inc. · Toxicology device
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Mar 1989
Decision
22d
Days
Class 2
Risk

K890883 is an FDA 510(k) clearance for the ABUSCREEN FP BUFFER REAGENT. Classified as Enzyme Immunoassay, Cocaine And Cocaine Metabolites (product code DIO), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Montclair, US). The FDA issued a Cleared decision on March 15, 1989 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3250 - 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 K890883 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1989
Decision Date March 15, 1989
Days to Decision 22 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 87d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3250
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 - DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites

All 80
Devices cleared under the same product code (DIO) and FDA review panel - the closest regulatory comparables to K890883.
EMIT(R) II COCAINE METABOLITE ASSAY
K902579 · Syva Co. · Jul 1990
HYCOR ACCUPINCH COCAINE TEST
K896937 · Hycor Biomedical, Inc. · Mar 1990
ADX COCAINE METABOLITE
K890788 · Abbott Laboratories · Aug 1989
ABUSCREEN FP FOR COCAINE METABOLITE
K890885 · Roche Diagnostic Systems, Inc. · Mar 1989
ABUSCREEN(R) ONTRAK(TM) FOR COCAINE
K881815 · Roche Diagnostic Systems, Inc. · Jul 1988
EMIT HVA COCAINE METABOLITE ASSAY
K881942 · Syva Co. · Jul 1988