Cleared Traditional

K895906 - ABUSCREEN ONTRAK FOR PHENCYCLIDINE (PCP)

K895906 · Roche Diagnostic Systems, Inc. · Toxicology device
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Jan 1990
Decision
112d
Days
-
Risk

K895906 is an FDA 510(k) clearance for the ABUSCREEN ONTRAK FOR PHENCYCLIDINE (PCP). Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by Roche Diagnostic Systems, Inc. (Montclair, US). The FDA issued a Cleared decision on January 26, 1990 after a review of 112 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 Roche Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K895906 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1989
Decision Date January 26, 1990
Days to Decision 112 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
25d slower than avg
Panel avg: 87d · This submission: 112d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LCM Enzyme Immunoassay, Phencyclidine
Device Class -

Regulatory Peers - LCM Enzyme Immunoassay, Phencyclidine

All 55
Devices cleared under the same product code (LCM) and FDA review panel - the closest regulatory comparables to K895906.
MILENIA(TM) PCP
K902960 · Diagnostic Products Corp. · Aug 1990
HYCOR ACCUPINCH PHENCYCLIDINE TEST
K900921 · Hycor Biomedical, Inc. · Apr 1990
TDX PHENCYCLIDINE II ASSAY
K900940 · Abbott Laboratories · Apr 1990
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