Cleared Traditional

K991505 - MICRO-STRIP FOR PHENCYCLIDINE METABOLITES

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

FDA 510(k) Submission Details - K991505

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
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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