Not Cleared Direct

DEN230068 - 3M™ Attest™ eBowie-Dick Test Card 10135 3M™ Attest™ eBowie-Dick Card Holder 10135CH 3M™ Attest™ eBowie-Dick Auto-reader 1190 (FDA 510(k) Clearance)

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

DEN230068 · 3M Company · General Hospital
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May 2024
Decision
235d
Days
Class 2
Risk

DEN230068 is an FDA 510(k) submission (not cleared) for the 3M™ Attest™ eBowie-Dick Test Card 10135 3M™ Attest™ eBowie-Dick Card Holder 1.... Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by 3M Company (St. Paul, US). The FDA issued a Not Cleared (DENG) decision on May 21, 2024 after a review of 235 days.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2800 - the FDA general hospital 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 General Hospital review framework.

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Submission Details

510(k) Number DEN230068 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received September 29, 2023
Decision Date May 21, 2024
Days to Decision 235 days
Submission Type Direct
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
107d slower than avg
Panel avg: 128d · This submission: 235d
Pathway characteristics

Device Classification

Product Code JOJ Indicator, Physical/chemical Sterilization Process
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2800
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 General Hospital devices follow this clearance model.

Regulatory Peers - JOJ Indicator, Physical/chemical Sterilization Process

All 264
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