Cleared Traditional

K890688 - ADX TM PHENCYCLIDINE

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.

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FDA 510(k) Submission Details - K890688

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.

LCM Device Classification - Class 0,

Product Code LCM Enzyme Immunoassay, Phencyclidine
Device Class -

Regulatory Peers - LCM Enzyme Immunoassay, Phencyclidine

All 62
Devices cleared under the same product code (LCM) and FDA review panel - the closest regulatory comparables to K890688.
HYCOR ACCUPINCH PHENCYCLIDINE TEST
K900921 · Hycor Biomedical, Inc. · Apr 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