Cleared Traditional

K161947 - Chagas Detect Plus Rapid Test (FDA 510(k) Clearance)

Class I Microbiology device.

K161947 · InBios International, Inc. · Microbiology device
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Dec 2016
Decision
155d
Days
Class 1
Risk

K161947 is an FDA 510(k) clearance for the Chagas Detect Plus Rapid Test. Classified as Enzyme Linked Immunosorbent Assay, T. Cruzi (product code MIU), Class I - General Controls.

Submitted by InBios International, Inc. (Seattle, US). The FDA issued a Cleared decision on December 16, 2016 after a review of 155 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 K161947 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2016
Decision Date December 16, 2016
Days to Decision 155 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
53d slower than avg
Panel avg: 102d · This submission: 155d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MIU Enzyme Linked Immunosorbent Assay, T. Cruzi
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3870
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.