Not Cleared Post-NSE

DEN100020 - DENV DETECT IGM CAPTURE ELISA

DEN100020 is an FDA 510(k) submission for DENV DETECT IGM CAPTURE ELISA, manufactured by Inbios Intl., Inc.. The device is a Class 2 Microbiology device with product code OSU cleared through the Post-NSE 510(k) pathway after a 170-day FDA review.

DEN100020 · Inbios Intl., Inc. · Microbiology device
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Apr 2011
Decision
170d
Days
Class 2
Risk

DEN100020 is an FDA 510(k) submission (not cleared) for the DENV DETECT IGM CAPTURE ELISA. Classified as Dengue Serological Reagents (product code OSU), Class II - Special Controls.

Submitted by Inbios Intl., Inc. (Seattle, US). The FDA issued a Not Cleared (DENG) decision on April 8, 2011 after a review of 170 days.

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 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.

FDA 510(k) Submission Details - DEN100020

510(k) Number DEN100020 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received October 20, 2010
Decision Date April 08, 2011
Days to Decision 170 days
Submission Type Post-NSE
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d slower than avg
Panel avg: 102d · This submission: 170d
Pathway characteristics

OSU Device Classification - Class 2, Special Controls

Product Code OSU Dengue Serological Reagents
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3945
Definition Dengue Virus Serological Reagents Are Devices That Consist Of Antigens And Antisera For The Detection Of Anti-dengue Antibodies, Individuals That Have Signs And Symptoms Consistent With Dengue. The Detection Aids In The Clinical Laboratory Diagnosis Of Dengue Fever Or Dengue Hemorrhagic Fever Caused By Dengue Virus. The Device Is Intended For Use In The Presumptive Diagnosis Of Patients 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.

DEN100020 · DENV DETECT IGM CAPTURE ELISA
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