Cleared Traditional

K911725 - ACA(R) URINE PHENCYCLIDINE (U PCP) SCREEN METHOD (FDA 510(k) Clearance)

K911725 · E.I. Dupont DE Nemours & Co., Inc. · Toxicology device
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Jun 1991
Decision
47d
Days
-
Risk

K911725 is an FDA 510(k) clearance for the ACA(R) URINE PHENCYCLIDINE (U PCP) SCREEN METHOD. Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by E.I. Dupont DE Nemours & Co., Inc. (Wilmington, US). The FDA issued a Cleared decision on June 3, 1991 after a review of 47 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 E.I. Dupont DE Nemours & Co., Inc. devices

Submission Details

510(k) Number K911725 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1991
Decision Date June 03, 1991
Days to Decision 47 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 87d · This submission: 47d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LCM Enzyme Immunoassay, Phencyclidine
Device Class -

Regulatory Peers - LCM Enzyme Immunoassay, Phencyclidine

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