Cleared Traditional

MICRO-STRIP FOR PHENCYCLIDINE METABOLITES (K991505) - FDA 510(k) Clearance

K991505 · Microdiagnostics, Inc. · Toxicology device
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Aug 1999
Decision
98d
Days
-
Risk

K991505 is an FDA 510(k) clearance for the MICRO-STRIP FOR PHENCYCLIDINE METABOLITES. Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by Microdiagnostics, Inc. (Laguna Niguel, US). The FDA issued a Cleared decision on August 5, 1999 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 Microdiagnostics, Inc. devices

Submission Details

510(k) Number K991505 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1999
Decision Date August 05, 1999
Days to Decision 98 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
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

All 87
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