Cleared Traditional

ADX TM PHENCYCLIDINE (K890688) - FDA 510(k) Clearance

K890688 · Abbott Laboratories · Toxicology device
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Aug 1989
Decision
192d
Days
-
Risk

K890688 is an FDA 510(k) clearance for the ADX TM PHENCYCLIDINE. Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

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. 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

Submission Details

510(k) Number K890688 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.

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 K890688.
MILENIA(TM) PCP
K902960 · Diagnostic Products Corp. · Aug 1990
TDX PHENCYCLIDINE II ASSAY
K900940 · Abbott Laboratories · Apr 1990
ABUSCREEN ONTRAK FOR PHENCYCLIDINE (PCP)
K895906 · Roche Diagnostic Systems, Inc. · Jan 1990
REVISED LABELING FOR PCP TEST KIT
K874267 · Roche Diagnostic Systems, Inc. · Nov 1987
LABELING CHANGE PCP (PHENCYCLIDINE) IN URINE
K873756 · Diagnostic Products Corp. · Oct 1987
TDX PHENCYCLIDINE
K854167 · Abbott Laboratories · Nov 1985