Cleared Traditional

TDX(R) BARBITURATES II ASSAY (K896550) - FDA 510(k) Clearance

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K896550 · Abbott Laboratories · Toxicology device
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Dec 1989
Decision
32d
Days
Class 2
Risk

K896550 is an FDA 510(k) clearance for the TDX(R) BARBITURATES II ASSAY. 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 December 19, 1989 after a review of 32 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

Submission Details

510(k) Number K896550 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1989
Decision Date December 19, 1989
Days to Decision 32 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
55d faster than avg
Panel avg: 87d · This submission: 32d
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 41
Devices cleared under the same product code (DIS) and FDA review panel - the closest regulatory comparables to K896550.
IL TEST BARBITURATE, 35289
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K903825 · Technicon Instruments Corp. · Sep 1990
EMIT(R) II BARBITURATE ASSAY
K902580 · Syva Co. · Jul 1990
ADX TM BARBITURATES
K890690 · Abbott Laboratories · Aug 1989
TDX BARBITURATES SERUM
K892650 · Abbott Laboratories · May 1989
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K890884 · Roche Diagnostic Systems, Inc. · Mar 1989