Cleared Traditional

K890884 - ABUSCREEN FP FOR BARBITURATES

K890884 is the FDA 510(k) clearance for ABUSCREEN FP FOR BARBITURATES by Roche Diagnostic Systems, Inc.. It is a Class 2 Toxicology device (product code DIS) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K890884 · Roche Diagnostic Systems, Inc. · Toxicology device
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Mar 1989
Decision
16d
Days
Class 2
Risk

K890884 is an FDA 510(k) clearance for the ABUSCREEN FP FOR BARBITURATES. Classified as Enzyme Immunoassay, Barbiturate (product code DIS), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Montclair, US). The FDA issued a Cleared decision on March 9, 1989 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3150 - 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 K890884 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1989
Decision Date March 09, 1989
Days to Decision 16 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
71d faster than avg
Panel avg: 87d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DIS Enzyme Immunoassay, Barbiturate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3150
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 - DIS Enzyme Immunoassay, Barbiturate

All 64
Devices cleared under the same product code (DIS) and FDA review panel - the closest regulatory comparables to K890884.
TDX(R) BARBITURATES II ASSAY
K896550 · Abbott Laboratories · Dec 1989
ADX TM BARBITURATES
K890690 · Abbott Laboratories · Aug 1989
TDX BARBITURATES SERUM
K892650 · Abbott Laboratories · May 1989
EMIT HVA BARBITURATE ASSAY
K882611 · Syva Co. · Aug 1988
REVISED LABELING FOR ADX BARBITURATES
K880012 · Abbott Laboratories · Mar 1988
REVISED LABELING FOR SYVA BARBITURATE ASSAYS
K874702 · Syva Co. · Jan 1988