Cleared Traditional

K101855 - PROFAST+ ASSAY (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K101855 · Gen-Probe Prodesse, Inc. · Microbiology device
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Jul 2010
Decision
22d
Days
Class 2
Risk

K101855 is an FDA 510(k) clearance for the PROFAST+ ASSAY. Classified as 2009 H1n1 Influenza Virus (swine Origin), Nucleic Acid Or Antigen, Detection And Identification (product code OQW), Class II - Special Controls.

Submitted by Gen-Probe Prodesse, Inc. (Waukesha, US). The FDA issued a Cleared decision on July 23, 2010 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3332 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Gen-Probe Prodesse, Inc. devices

Submission Details

510(k) Number K101855 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2010
Decision Date July 23, 2010
Days to Decision 22 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 102d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OQW 2009 H1n1 Influenza Virus (swine Origin), Nucleic Acid Or Antigen, Detection And Identification
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3332
Definition 2009 H1n1 Influenza Virus Detection And Identification Reagents Are Used To Directly Detect And Differentiate The 2009 H1n1 Influenza Virus In Human Respiratory Specimens
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.