Cleared Traditional

EMIT HVA PHENCYCLIDINE ASSAY (K882179) - FDA 510(k) Clearance

K882179 · Syva Co. · Toxicology device
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Jul 1988
Decision
49d
Days
-
Risk

K882179 is an FDA 510(k) clearance for the EMIT HVA PHENCYCLIDINE ASSAY. Classified as Radioimmunoassay, Phencyclidine (product code LCL).

Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on July 12, 1988 after a review of 49 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 Syva Co. devices

Submission Details

510(k) Number K882179 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1988
Decision Date July 12, 1988
Days to Decision 49 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
38d faster than avg
Panel avg: 87d · This submission: 49d
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 K882179.
ABUSCREEN FP FOR PHENCYCLIDINE
K890882 · Roche Diagnostic Systems, Inc. · Mar 1989
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