Cleared Traditional

TDX PHENCYCLIDINE (K854167) - FDA 510(k) Clearance

K854167 · Abbott Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1985
Decision
21d
Days
-
Risk

K854167 is an FDA 510(k) clearance for the TDX PHENCYCLIDINE. Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on November 5, 1985 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Chemistry 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 K854167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1985
Decision Date November 05, 1985
Days to Decision 21 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
67d faster than avg
Panel avg: 88d · This submission: 21d
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 K854167.
ADX TM PHENCYCLIDINE
K890688 · Abbott Laboratories · Aug 1989
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
STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNOASS
K853548 · American Dade · Sep 1985
EMIT 700 PHENCYCLIDINE ASSAY
K843509 · Syva Co. · Sep 1984
EMIT ST SERUM PHENCYCLIDINE ASSAY
K840199 · Syva Co. · Mar 1984