Cleared Traditional

ABUSCREEN FP FOR PHENCYCLIDINE (K890882) - FDA 510(k) Clearance

K890882 · Roche Diagnostic Systems, Inc. · Toxicology device
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Mar 1989
Decision
22d
Days
-
Risk

K890882 is an FDA 510(k) clearance for the ABUSCREEN FP FOR PHENCYCLIDINE. Classified as Radioimmunoassay, Phencyclidine (product code LCL).

Submitted by Roche Diagnostic Systems, Inc. (Montclair, US). The FDA issued a Cleared decision on March 15, 1989 after a review of 22 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.

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Submission Details

510(k) Number K890882 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1989
Decision Date March 15, 1989
Days to Decision 22 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 87d · This submission: 22d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LCL Radioimmunoassay, Phencyclidine
Device Class -