Cleared Traditional

K982801 - AUTO-LYTE PCP EIA

K982801 · OraSure Technologies, Inc. · Toxicology device
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Nov 1998
Decision
86d
Days
-
Risk

K982801 is an FDA 510(k) clearance for the AUTO-LYTE PCP EIA, MODEL #1254U. Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by OraSure Technologies, Inc. (Bethlehem, US). The FDA issued a Cleared decision on November 4, 1998 after a review of 86 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 OraSure Technologies, Inc. devices

Submission Details

510(k) Number K982801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1998
Decision Date November 04, 1998
Days to Decision 86 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
1d faster than avg
Panel avg: 87d · This submission: 86d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LCM Enzyme Immunoassay, Phencyclidine
Device Class -

Regulatory Peers - LCM Enzyme Immunoassay, Phencyclidine

All 57
Devices cleared under the same product code (LCM) and FDA review panel - the closest regulatory comparables to K982801.
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AT HOME DRUG TEST, MODEL 9133
K994236 · Phamatech · Dec 1999
QUICKSCREEN ONE STEP PCP SCREENING TEST
K974582 · Phamatech · Feb 1998
MODIFIED CEDIA DAU PCP ASSAY
K972963 · Boehringer Mannheim Corp. · Sep 1997
ONTRAK TESTCUP 5 (MODIFICATION)
K964355 · Roche Diagnostic Systems, Inc. · Dec 1996