Cleared Traditional

AXSYM PHENCYCLIDINE II (K953534) - FDA 510(k) Clearance

K953534 · Abbott Laboratories · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
91d
Days
-
Risk

K953534 is an FDA 510(k) clearance for the AXSYM PHENCYCLIDINE II. Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on October 26, 1995 after a review of 91 days - within the typical 510(k) review window.

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 K953534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1995
Decision Date October 26, 1995
Days to Decision 91 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 87d · This submission: 91d
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 K953534.
ONTRAK TESTCUP 5, CAT. 07 6481 7
K994030 · Roche Diagnostics Corp. · Jan 2000
MODIFIED CEDIA DAU PCP ASSAY
K972963 · Boehringer Mannheim Corp. · Sep 1997
ONTRAK TESTCUP 5 (MODIFICATION)
K964355 · Roche Diagnostic Systems, Inc. · Dec 1996
URINE PHENCYCLIDINE SCREEN FLEX(TM) REAGENT CARTRIDGE
K950183 · E.I. Dupont DE Nemours & Co., Inc. · Mar 1995
EMIT IIC PHENCYCLIDINE ASSAY
K935191 · Syva Co. · Feb 1995
ABUSCREEN ONLINE FOR PHENCYCLIDINE
K920935 · Roche Diagnostic Systems, Inc. · Mar 1992