Cleared Traditional

TDX BARBITURATES SERUM (K892650) - FDA 510(k) Clearance

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

K892650 · Abbott Laboratories · Chemistry device
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May 1989
Decision
34d
Days
Class 2
Risk

K892650 is an FDA 510(k) clearance for the TDX BARBITURATES SERUM. 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 May 16, 1989 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3150 - the FDA in vitro diagnostics and chemistry 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 K892650 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1989
Decision Date May 16, 1989
Days to Decision 34 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 88d · This submission: 34d
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 Chemistry 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 K892650.
EMIT(R) II BARBITURATE ASSAY
K902580 · Syva Co. · Jul 1990
TDX(R) BARBITURATES II ASSAY
K896550 · Abbott Laboratories · Dec 1989
ADX TM BARBITURATES
K890690 · Abbott Laboratories · Aug 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