Cleared Traditional

K181473 - DENV Detect NS1 ELISA (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K181473 · InBios International, Inc. · Microbiology device
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Aug 2018
Decision
84d
Days
Class 2
Risk

K181473 is an FDA 510(k) clearance for the DENV Detect NS1 ELISA. Classified as Dengue Virus Antigen Assay (product code QCU), Class II - Special Controls.

Submitted by InBios International, Inc. (Seattle, US). The FDA issued a Cleared decision on August 27, 2018 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3945 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all InBios International, Inc. devices

Submission Details

510(k) Number K181473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2018
Decision Date August 27, 2018
Days to Decision 84 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
18d faster than avg
Panel avg: 102d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QCU Dengue Virus Antigen Assay
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3945
Definition Qualitative Detection Of Dengue Virus Antigen In Human Serum Or Plasma Collected From Human Patients With Signs And Symptoms Consistent With Dengue Virus Infection
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.