Cleared Traditional

K874267 - REVISED LABELING FOR PCP TEST KIT

K874267 · Roche Diagnostic Systems, Inc. · Toxicology device
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Nov 1987
Decision
24d
Days
-
Risk

K874267 is an FDA 510(k) clearance for the REVISED LABELING FOR PCP TEST KIT. Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by Roche Diagnostic Systems, Inc. (Nutley, US). The FDA issued a Cleared decision on November 13, 1987 after a review of 24 days - a notably fast clearance 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: 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 Roche Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K874267 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1987
Decision Date November 13, 1987
Days to Decision 24 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
63d faster than avg
Panel avg: 87d · This submission: 24d
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 K874267.
TDX PHENCYCLIDINE II ASSAY
K900940 · Abbott Laboratories · Apr 1990
ABUSCREEN ONTRAK FOR PHENCYCLIDINE (PCP)
K895906 · Roche Diagnostic Systems, Inc. · Jan 1990
ADX TM PHENCYCLIDINE
K890688 · Abbott Laboratories · Aug 1989
LABELING CHANGE PCP (PHENCYCLIDINE) IN URINE
K873756 · Diagnostic Products Corp. · Oct 1987
TDX PHENCYCLIDINE
K854167 · Abbott Laboratories · Nov 1985
STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNOASS
K853548 · American Dade · Sep 1985