Cleared Traditional

K152176 - Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators (FDA 510(k) Clearance)

K152176 · Immunalysis Corporation · Toxicology device
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Sep 2015
Decision
31d
Days
-
Risk

K152176 is an FDA 510(k) clearance for the Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators. Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by Immunalysis Corporation (Pomona, US). The FDA issued a Cleared decision on September 4, 2015 after a review of 31 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 Immunalysis Corporation devices

Submission Details

510(k) Number K152176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2015
Decision Date September 04, 2015
Days to Decision 31 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
56d faster than avg
Panel avg: 87d · This submission: 31d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LCM Enzyme Immunoassay, Phencyclidine
Device Class -