Cleared Traditional

K191172 - Cepheid Xpert MRSA NxG Control Panel

K191172 is the FDA 510(k) clearance for Cepheid Xpert MRSA NxG Control Panel by Microbiologics, Inc.. It is a Class 2 Microbiology device (product code PMN) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K191172 · Microbiologics, Inc. · Microbiology device
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Jun 2019
Decision
50d
Days
Class 2
Risk

K191172 is an FDA 510(k) clearance for the Cepheid Xpert MRSA NxG 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 June 20, 2019 after a review of 50 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 K191172 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2019
Decision Date June 20, 2019
Days to Decision 50 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 102d · This submission: 50d
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

All 25
Devices cleared under the same product code (PMN) and FDA review panel - the closest regulatory comparables to K191172.
FilmArray BCID2 Control Panel M416
K200010 · Maine Molecular Quality Controls, Inc. · Apr 2020
Cepheid Xpert Respiratory Control Panel
K190086 · Microbiologics, Inc. · Oct 2019
Cepheid Xpert SA Nasal Complete Control Panel
K191168 · Microbiologics, Inc. · Jun 2019
Cepheid Xpert CT/NG Control Panel
K190223 · Microbiologics, Inc. · May 2019
FilmArray Pneumonia/Pneumoniaplus Control
K190222 · Maine Molecular Quality Controls, Inc. · May 2019
Cepheid Xpert C. difficile/Epi Control Panel
K190463 · Microbiologics, Inc. · Apr 2019