Not Cleared Direct

DEN180069 - ZIKV Detect 2.0 IgM Capture ELISA (FDA 510(k) Clearance)

Class II Microbiology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN180069 · InBios International, Inc. · Microbiology device
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May 2019
Decision
148d
Days
Class 2
Risk

DEN180069 is an FDA 510(k) submission (not cleared) for the ZIKV Detect 2.0 IgM Capture ELISA. Classified as Zika Virus Serological Reagents (product code QFO), Class II - Special Controls.

Submitted by InBios International, Inc. (Seattle, US). The FDA issued a Not Cleared (DENG) decision on May 23, 2019 after a review of 148 days.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3935 - the FDA microbiology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Microbiology review framework.

View all InBios International, Inc. devices

Submission Details

510(k) Number DEN180069 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received December 26, 2018
Decision Date May 23, 2019
Days to Decision 148 days
Submission Type Direct
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 102d · This submission: 148d
Pathway characteristics

Device Classification

Product Code QFO Zika Virus Serological Reagents
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3935
Definition Zika Virus Serological Reagents Are Devices That Consist Of Antigens And Antisera For The Diagnosis Of Zika Virus Infection In Human Clinical Specimens From Individuals That Have Signs And Symptoms Consistent With Zika Virus Infection And/or Epidemiological Risk Factors. The Device Aids In The Presumptive Clinical Diagnosis Of Zika Virus Infection In Conjunction With Other Clinical And Laboratory Findings.
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.