Cleared Traditional

K000399 - STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541 (FDA 510(k) Clearance)

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

Submission Details

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
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 87d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LCM Enzyme Immunoassay, Phencyclidine
Device Class -

Regulatory Peers - LCM Enzyme Immunoassay, Phencyclidine

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