Not Cleared Direct

DEN190025 - OraQuick Ebola Rapid Antigen Test (FDA 510(k) Clearance)

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

DEN190025 · OraSure Technologies, Inc. · Microbiology device
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Oct 2019
Decision
150d
Days
Class 2
Risk

DEN190025 is an FDA 510(k) submission (not cleared) for the OraQuick Ebola Rapid Antigen Test. Classified as Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens (product code QID), Class II - Special Controls.

Submitted by OraSure Technologies, Inc. (Bethlehem, US). The FDA issued a Not Cleared (DENG) decision on October 10, 2019 after a review of 150 days.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.4002 - 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 OraSure Technologies, Inc. devices

Submission Details

510(k) Number DEN190025 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received May 13, 2019
Decision Date October 10, 2019
Days to Decision 150 days
Submission Type Direct
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d slower than avg
Panel avg: 102d · This submission: 150d
Pathway characteristics

Device Classification

Product Code QID Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.4002
Definition A Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens Is Identified As An In Vitro Diagnostic Device Intended For The Detection Of Antigens Of Microbial Agents In Specimens Collected From Patients With Signs And Symptoms Of Infection With Biothreat Microbial Agents And Who Have Been Exposed To These Agents Or Are Suspected Or At Risk Of Exposure.  devices To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens May Be Used For Cadaver Testing If The Cadaver Constitutes A Source Of Human-to-human Transmission And If Testing Is Performed To Prevent Human Disease.
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.