Cleared Traditional

K000399 - STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541

K000399 · OraSure Technologies, Inc. · Toxicology device
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May 2000
Decision
98d
Days
-
Risk

K000399 is an FDA 510(k) clearance for the STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541. Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by OraSure Technologies, Inc. (Bethlehem, US). The FDA issued a Cleared decision on May 15, 2000 after a review of 98 days - within the typical 510(k) review window.

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.

View all OraSure Technologies, Inc. devices

FDA 510(k) Submission Details - K000399

510(k) Number K000399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2000
Decision Date May 15, 2000
Days to Decision 98 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
11d slower than avg
Panel avg: 87d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

LCM Device Classification - Class 0,

Product Code LCM Enzyme Immunoassay, Phencyclidine
Device Class -

Regulatory Peers - LCM Enzyme Immunoassay, Phencyclidine

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