Cleared Traditional

K974582 - QUICKSCREEN ONE STEP PCP SCREENING TEST

K974582 · Phamatech · Toxicology device
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Feb 1998
Decision
58d
Days
-
Risk

K974582 is an FDA 510(k) clearance for the QUICKSCREEN ONE STEP PCP SCREENING TEST. Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by Phamatech (San Diego, US). The FDA issued a Cleared decision on February 4, 1998 after a review of 58 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 Phamatech devices

Submission Details

510(k) Number K974582 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1997
Decision Date February 04, 1998
Days to Decision 58 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
29d faster than avg
Panel avg: 87d · This submission: 58d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LCM Enzyme Immunoassay, Phencyclidine
Device Class -

Regulatory Peers - LCM Enzyme Immunoassay, Phencyclidine

All 56
Devices cleared under the same product code (LCM) and FDA review panel - the closest regulatory comparables to K974582.
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K964355 · Roche Diagnostic Systems, Inc. · Dec 1996
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