Cleared Traditional

K882663 - BARBITURATE ENZYME IMMUNOASSAY KIT

K882663 is the FDA 510(k) clearance for BARBITURATE ENZYME IMMUNOASSAY KIT by General Diagnostics. It is a Class 2 Toxicology device (product code DIS) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K882663 · General Diagnostics · Toxicology device
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Sep 1988
Decision
84d
Days
Class 2
Risk

K882663 is an FDA 510(k) clearance for the BARBITURATE ENZYME IMMUNOASSAY KIT. Classified as Enzyme Immunoassay, Barbiturate (product code DIS), Class II - Special Controls.

Submitted by General Diagnostics (Great Neck, US). The FDA issued a Cleared decision on September 19, 1988 after a review of 84 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 General Diagnostics devices

Submission Details

510(k) Number K882663 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 1988
Decision Date September 19, 1988
Days to Decision 84 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
3d faster than avg
Panel avg: 87d · This submission: 84d
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 67
Devices cleared under the same product code (DIS) and FDA review panel - the closest regulatory comparables to K882663.
ADX TM BARBITURATES
K890690 · Abbott Laboratories · Aug 1989
TDX BARBITURATES SERUM
K892650 · Abbott Laboratories · May 1989
ABUSCREEN FP FOR BARBITURATES
K890884 · Roche Diagnostic Systems, Inc. · Mar 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