Cleared Traditional

SMART LEISH, MODEL LGM1-050 (K081868) - FDA 510(k) Clearance

Class I Microbiology device.

K081868 · U.S. Army Medical Research Institute of Infectious · Microbiology device
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May 2011
Decision
1057d
Days
Class 1
Risk

K081868 is an FDA 510(k) clearance for the SMART LEISH, MODEL LGM1-050. Classified as Nucleic Amplification Assays For The Detection Of Leishmania Nucleic Acids (product code OUZ), Class I - General Controls.

Submitted by U.S. Army Medical Research Institute of Infectious (Fort Detrick, US). The FDA issued a Cleared decision on May 25, 2011 after a review of 1057 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3870 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

View all U.S. Army Medical Research Institute of Infectious devices

Submission Details

510(k) Number K081868 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2008
Decision Date May 25, 2011
Days to Decision 1057 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
955d slower than avg
Panel avg: 102d · This submission: 1057d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OUZ Nucleic Amplification Assays For The Detection Of Leishmania Nucleic Acids
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3870
Definition Detection Of Leishmania Species In Skin Lesions.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.