Cleared Traditional

K000462 - URINE PHENCYCLIDINE (PCP) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 94A

K000462 · Dade Behring, Inc. · Toxicology device
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Apr 2000
Decision
55d
Days
-
Risk

K000462 is an FDA 510(k) clearance for the URINE PHENCYCLIDINE (PCP) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 94A. Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on April 6, 2000 after a review of 55 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 Dade Behring, Inc. devices

FDA 510(k) Submission Details - K000462

510(k) Number K000462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2000
Decision Date April 06, 2000
Days to Decision 55 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
32d faster than avg
Panel avg: 87d · This submission: 55d
Pathway characteristics
Predicate-based equivalence.

LCM Device Classification - Class 0,

Product Code LCM Enzyme Immunoassay, Phencyclidine
Device Class -

Regulatory Peers - LCM Enzyme Immunoassay, Phencyclidine

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