Cleared Traditional

K000402 - SCREENERS PHENCYCLIDINE (PCP) TEST

K000402 · Drug Detection Devices, Ltd. · Toxicology device
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Apr 2000
Decision
71d
Days
-
Risk

K000402 is an FDA 510(k) clearance for the SCREENERS PHENCYCLIDINE (PCP) TEST, DRUGSCREEN DIP PHENCYCLIDINE (PCP) TEST. Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by Drug Detection Devices, Ltd. (Alpharetta, US). The FDA issued a Cleared decision on April 18, 2000 after a review of 71 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 Drug Detection Devices, Ltd. devices

Submission Details

510(k) Number K000402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2000
Decision Date April 18, 2000
Days to Decision 71 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 87d · This submission: 71d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LCM Enzyme Immunoassay, Phencyclidine
Device Class -

Regulatory Peers - LCM Enzyme Immunoassay, Phencyclidine

All 57
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URINE PHENCYCLIDINE (PCP) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 94A
K000462 · Dade Behring, Inc. · Apr 2000
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K994017 · Roche Diagnostics Corp. · Jan 2000