Cleared Traditional

K161947 - Chagas Detect Plus Rapid Test

K161947 is an FDA 510(k) clearance for Chagas Detect Plus Rapid Test, manufactured by InBios International, Inc.. The device is a Class 1 Microbiology device with product code MIU cleared through the Traditional 510(k) pathway after a 155-day FDA review.

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

FDA 510(k) Submission Details - K161947

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.

MIU Device Classification - Class 1, General Controls

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.

Regulatory Peers - MIU Enzyme Linked Immunosorbent Assay, T. Cruzi

Devices cleared under the same product code (MIU) and FDA review panel - the closest regulatory comparables to K161947.
ORTHO T. CRUZI ELISA TEST SYSTEM
K072732 · Ortho-Clinical Diagnostics, Inc. · Apr 2009
WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254
K023889 · Wiener Laboratories Saic · Feb 2004
HEMAGEN CHAGAS' KIT (EIA METHOD)
K930272 · Hemagen Diagnostics, Inc. · May 1995
ABBOTT CHAGAS ANTIBODY EIA
K933716 · Abbott Laboratories · Dec 1994
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K911233 · Gull Laboratories, Inc. · May 1992