Cleared Traditional

TDX PHENCYCLIDINE II ASSAY (K900940) - FDA 510(k) Clearance

K900940 · Abbott Laboratories · Toxicology device
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Apr 1990
Decision
56d
Days
-
Risk

K900940 is an FDA 510(k) clearance for the TDX PHENCYCLIDINE II ASSAY. Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on April 25, 1990 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel. 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 K900940 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1990
Decision Date April 25, 1990
Days to Decision 56 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
31d faster than avg
Panel avg: 87d · This submission: 56d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LCM Enzyme Immunoassay, Phencyclidine
Device Class -

Regulatory Peers - LCM Enzyme Immunoassay, Phencyclidine

All 37
Devices cleared under the same product code (LCM) and FDA review panel - the closest regulatory comparables to K900940.
ACA(R) URINE PHENCYCLIDINE (U PCP) SCREEN METHOD
K911725 · E.I. Dupont DE Nemours & Co., Inc. · Jun 1991
EMIT (R) II PHENCYCLIDINE ASSAY
K904765 · Syva Co. · Nov 1990
MILENIA(TM) PCP
K902960 · Diagnostic Products Corp. · Aug 1990
ABUSCREEN ONTRAK FOR PHENCYCLIDINE (PCP)
K895906 · Roche Diagnostic Systems, Inc. · Jan 1990
ADX TM PHENCYCLIDINE
K890688 · Abbott Laboratories · Aug 1989
REVISED LABELING FOR PCP TEST KIT
K874267 · Roche Diagnostic Systems, Inc. · Nov 1987