Cleared Traditional

K864993 - QUALI. ENZYME IMMUNO. OF BARBITURATES I...

K864993 is the FDA 510(k) clearance for QUALI. ENZYME IMMUNO. OF BARBITURATES I... by General Diagnostics. It is a Class 2 Toxicology device (product code DIS) cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K864993 · General Diagnostics · Toxicology device
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Mar 1987
Decision
99d
Days
Class 2
Risk

K864993 is an FDA 510(k) clearance for the QUALI. ENZYME IMMUNO. OF BARBITURATES IN URINE. 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 March 31, 1987 after a review of 99 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K864993 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1986
Decision Date March 31, 1987
Days to Decision 99 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
12d slower than avg
Panel avg: 87d · This submission: 99d
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 K864993.
REVISED LABELING FOR BARBITURATE TEST KIT
K874266 · Roche Diagnostic Systems, Inc. · Nov 1987
ACA URINE BARBITURATES SCREEN METHOD
K873623 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1987
LABELING CHANGE BARBITURATES IN URINE
K873754 · Diagnostic Products Corp. · Oct 1987
COAT-A-COUNT BARBITURATES TKBA1 AND TKBA5
K870936 · Diagnostic Products Corp. · Mar 1987
ABUSCREEN (R) EIA BARBITURATE
K870378 · Roche Diagnostic Systems, Inc. · Mar 1987
EMIT D.A.U. BARBITURATE ASSAY
K842675 · Syva Co. · Sep 1984