Cleared Traditional

K880012 - REVISED LABELING FOR ADX BARBITURATES

K880012 is an FDA 510(k) clearance for REVISED LABELING FOR ADX BARBITURATES, manufactured by Abbott Laboratories. The device is a Class 2 Toxicology device with product code DIS cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K880012 · Abbott Laboratories · Toxicology device
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Mar 1988
Decision
57d
Days
Class 2
Risk

K880012 is an FDA 510(k) clearance for the REVISED LABELING FOR ADX BARBITURATES. Classified as Enzyme Immunoassay, Barbiturate (product code DIS), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on March 1, 1988 after a review of 57 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K880012

510(k) Number K880012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1988
Decision Date March 01, 1988
Days to Decision 57 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
30d faster than avg
Panel avg: 87d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DIS Device Classification - Class 2, Special Controls

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 74
Devices cleared under the same product code (DIS) and FDA review panel - the closest regulatory comparables to K880012.
ABUSCREEN FP FOR BARBITURATES
K890884 · Roche Diagnostic Systems, Inc. · Mar 1989
BARBITURATE ENZYME IMMUNOASSAY KIT
K882663 · General Diagnostics · Sep 1988
EMIT HVA BARBITURATE ASSAY
K882611 · Syva Co. · Aug 1988
REVISED LABELING FOR SYVA BARBITURATE ASSAYS
K874702 · Syva Co. · Jan 1988
REVISED LABELING FOR TDX BARBITURATES
K874483 · Abbott Laboratories · Nov 1987
REVISED LABELING FOR ABUSCREEN EIA BARBITURATE
K874210 · Roche Diagnostic Systems, Inc. · Nov 1987