Cleared Traditional

PCP DIRECT RIA KIT (I-125) (K913864) - FDA 510(k) Clearance

K913864 · Immunalysis Corporation · Toxicology device

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Oct 1991

Decision

45d

Days

Risk

K913864 is an FDA 510(k) clearance for the PCP DIRECT RIA KIT (I-125). Classified as Radioimmunoassay, Phencyclidine (product code LCL).

Submitted by Immunalysis Corporation (Glendale, US). The FDA issued a Cleared decision on October 11, 1991 after a review of 45 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	K913864 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 27, 1991
Decision Date	October 11, 1991
Days to Decision	45 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

42d faster than avg

Panel avg: 87d · This submission: 45d

Pathway characteristics

Predicate-based equivalence.

Device Classification

Product Code	LCL Radioimmunoassay, Phencyclidine
Device Class	-

Regulatory Peers - LCL Radioimmunoassay, Phencyclidine

All 10

Devices cleared under the same product code (LCL) and FDA review panel - the closest regulatory comparables to K913864.

ABUSCREEN FP FOR PHENCYCLIDINE

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EMIT HVA PHENCYCLIDINE ASSAY

K882179 · Syva Co. · Jul 1988

REVISED LABELING FOR ADX PHENCYCLIDINE

K880011 · Abbott Laboratories · Feb 1988

REVISED LABELING FOR SYVA PHENCYCLIDINE ASSAYS

K874626 · Syva Co. · Jan 1988

REVISED LABELING FOR TDX PHENCYCLIDINE

K874484 · Abbott Laboratories · Nov 1987

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K913864

Immunalysis Corporation

Glendale, CA · US

JAMES R SOARES

Regulatory profile

50 submissions 50 cleared

100% clearance rate · Active in Toxicology

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Sourced from FDA 510(k) public files . Updated monthly.

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