Cleared Traditional

K060353 - ACRO RAPID PHENCYCLIDINE URINE TEST

K060353 · Acro Biotech, LLC · Toxicology device
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May 2006
Decision
79d
Days
-
Risk

K060353 is an FDA 510(k) clearance for the ACRO RAPID PHENCYCLIDINE URINE TEST, CATALOG PCP001000. Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by Acro Biotech, LLC (Rancho Cucamonga, US). The FDA issued a Cleared decision on May 3, 2006 after a review of 79 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 Acro Biotech, LLC devices

Submission Details

510(k) Number K060353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2006
Decision Date May 03, 2006
Days to Decision 79 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 87d · This submission: 79d
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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