Cleared Traditional

K190223 - Cepheid Xpert CT/NG Control Panel

K190223 is the FDA 510(k) clearance for Cepheid Xpert CT/NG Control Panel by Microbiologics, Inc.. It is a Class 2 Microbiology device (product code PMN) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K190223 · Microbiologics, Inc. · Microbiology device
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May 2019
Decision
92d
Days
Class 2
Risk

K190223 is an FDA 510(k) clearance for the Cepheid Xpert CT/NG 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 May 8, 2019 after a review of 92 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Microbiologics, Inc. devices

Submission Details

510(k) Number K190223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2019
Decision Date May 08, 2019
Days to Decision 92 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
10d faster than avg
Panel avg: 102d · This submission: 92d
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 K190223.
Cepheid Xpert Respiratory Control Panel
K190086 · Microbiologics, Inc. · Oct 2019
Cepheid Xpert SA Nasal Complete Control Panel
K191168 · Microbiologics, Inc. · Jun 2019
Cepheid Xpert MRSA NxG Control Panel
K191172 · Microbiologics, Inc. · Jun 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
Cepheid Xpert GBS LB Control Panel
K182472 · Microbiologics, Inc. · Nov 2018