Cleared Traditional

K181135 - Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay (FDA 510(k) Clearance)

K181135 · Immunalysis Corporation · Toxicology device
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Jan 2019
Decision
269d
Days
-
Risk

K181135 is an FDA 510(k) clearance for the Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay. Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by Immunalysis Corporation (Pomona, US). The FDA issued a Cleared decision on January 24, 2019 after a review of 269 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K181135 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2018
Decision Date January 24, 2019
Days to Decision 269 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
182d slower than avg
Panel avg: 87d · This submission: 269d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LCM Enzyme Immunoassay, Phencyclidine
Device Class -