Cleared Traditional

TDX METHADONE ASSAY (K884968) - FDA 510(k) Clearance

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

K884968 · Abbott Laboratories · Toxicology device
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Dec 1988
Decision
16d
Days
Class 2
Risk

K884968 is an FDA 510(k) clearance for the TDX METHADONE ASSAY. Classified as Enzyme Immunoassay, Methadone (product code DJR), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on December 16, 1988 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3620 - 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 K884968 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1988
Decision Date December 16, 1988
Days to Decision 16 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
71d faster than avg
Panel avg: 87d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DJR Enzyme Immunoassay, Methadone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3620
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 - DJR Enzyme Immunoassay, Methadone

All 28
Devices cleared under the same product code (DJR) and FDA review panel - the closest regulatory comparables to K884968.
IL TEST METHADONE
K920858 · Instrumentation Laboratory CO · Apr 1992
SYVA EMIT II METHADONE ASSAY
K920751 · Syva Co. · Mar 1992
REMEDI(TM) DRUG PROFILING SYSTEM, MODIFICATION
K911954 · Bio-Rad · May 1991
REVISED LABELING FOR SYVA METHADONE ASSAYS
K873899 · Syva Co. · Oct 1987
LABELING CHANGES COAT-A-COUNT METHADONE IN URINE
K873750 · Diagnostic Products Corp. · Oct 1987
COAT-A-COUNT METHADONE TKMD1
K870937 · Diagnostic Products Corp. · Mar 1987