Cleared Traditional

K190463 - Cepheid Xpert C. difficile/Epi Control Panel (FDA 510(k) Clearance)

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

K190463 · Microbiologics, Inc. · Microbiology device
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Apr 2019
Decision
52d
Days
Class 2
Risk

K190463 is an FDA 510(k) clearance for the Cepheid Xpert C. difficile/Epi Control Panel. Classified as Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays (product code PMN), Class II - Special Controls.

Submitted by Microbiologics, Inc. (St. Cloud, US). The FDA issued a Cleared decision on April 19, 2019 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3920 - 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 Microbiologics, Inc. devices

Submission Details

510(k) Number K190463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2019
Decision Date April 19, 2019
Days to Decision 52 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
50d faster than avg
Panel avg: 102d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3920
Definition Assayed External Quality Control Material To Monitor The Performance Of Microbiology Nucleic Acid Assays For In Vitro Diagnostic Use.
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.

Regulatory Peers - PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays

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