Cleared Traditional

K141341 - CL DETECT RAPID TEST (FDA 510(k) Clearance)

Class I Microbiology device.

K141341 · InBios International, Inc. · Microbiology device
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Nov 2014
Decision
177d
Days
Class 1
Risk

K141341 is an FDA 510(k) clearance for the CL DETECT RAPID TEST. Classified as Leishmania Spp. Antigen Detection Assay (product code PIT), Class I - General Controls.

Submitted by InBios International, Inc. (Seattle, US). The FDA issued a Cleared decision on November 14, 2014 after a review of 177 days - an extended review cycle.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all InBios International, Inc. devices

Submission Details

510(k) Number K141341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2014
Decision Date November 14, 2014
Days to Decision 177 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 102d · This submission: 177d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code PIT Leishmania Spp. Antigen Detection Assay
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3870
Definition An In Vitro Diagnostic Test For The Detection Of Leishmania Spp. Antigens To Aid In The Diagnosis Of Leishmania Spp. Infection.
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.