Cleared Traditional

K890690 - ADX TM BARBITURATES

K890690 is an FDA 510(k) clearance for ADX TM 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 192-day FDA review.

K890690 · Abbott Laboratories · Toxicology device
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Aug 1989
Decision
192d
Days
Class 2
Risk

K890690 is an FDA 510(k) clearance for the ADX TM 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 August 25, 1989 after a review of 192 days - an extended review 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: 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.

View all Abbott Laboratories devices

FDA 510(k) Submission Details - K890690

510(k) Number K890690 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 1989
Decision Date August 25, 1989
Days to Decision 192 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
105d slower than avg
Panel avg: 87d · This submission: 192d
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 K890690.
DRUG OF ABUSE ANALYSIS SYSTEM
K903825 · Technicon Instruments Corp. · Sep 1990
EMIT(R) II BARBITURATE ASSAY
K902580 · Syva Co. · Jul 1990
TDX(R) BARBITURATES II ASSAY
K896550 · Abbott Laboratories · Dec 1989
TDX BARBITURATES SERUM
K892650 · Abbott Laboratories · May 1989
ABUSCREEN FP FOR BARBITURATES
K890884 · Roche Diagnostic Systems, Inc. · Mar 1989
BARBITURATE ENZYME IMMUNOASSAY KIT
K882663 · General Diagnostics · Sep 1988