Not Cleared Direct

DEN230092 - Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390) (FDA 510(k) Clearance)

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

DEN230092 · Diasorin Molecular, LLC · Microbiology device
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Jul 2024
Decision
200d
Days
Class 2
Risk

DEN230092 is an FDA 510(k) submission (not cleared) for the Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C.... Classified as Device To Detect Microbial Colonization Directly From Clinical Specimens. (product code SBT), Class II - Special Controls.

Submitted by Diasorin Molecular, LLC (Cypress, US). The FDA issued a Not Cleared (DENG) decision on July 15, 2024 after a review of 200 days.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3967 - 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 Diasorin Molecular, LLC devices

Submission Details

510(k) Number DEN230092 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received December 28, 2023
Decision Date July 15, 2024
Days to Decision 200 days
Submission Type Direct
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d slower than avg
Panel avg: 102d · This submission: 200d
Pathway characteristics

Device Classification

Product Code SBT Device To Detect Microbial Colonization Directly From Clinical Specimens.
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3967
Definition A Device To Detect Microbial Colonization Directly From Clinical Specimens Is A Qualitative In Vitro Diagnostic Device Intended For The Detection And Identification Of Microbial-associated Targets From Patients Who Are Suspected Of Being Colonized With A Microbial Pathogen And May Present A Risk Of Transmission To Other Patients And Health Care Workers. This Device Is Intended To Aid In The Detection Of Microbial Colonizers For The Prevention And Control Of Infection In Healthcare Settings When Used In Conjunction With 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.