Cleared Traditional

K190441 - Xpert CT/NG

K190441 is the FDA 510(k) clearance for Xpert CT/NG by Cepheid. It is a Class 2 Microbiology device (product code QEP) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K190441 · Cepheid · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2019
Decision
87d
Days
Class 2
Risk

K190441 is an FDA 510(k) clearance for the Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infini.... Classified as Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections (product code QEP), Class II - Special Controls.

Submitted by Cepheid (Sunnyvale, US). The FDA issued a Cleared decision on May 23, 2019 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3393 - 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 Cepheid devices

Submission Details

510(k) Number K190441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2019
Decision Date May 23, 2019
Days to Decision 87 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
15d faster than avg
Panel avg: 102d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QEP Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3393
Definition A Device To Detect Nucleic Acids From Non-viral Microorganism(s) Causing Sexually Transmitted Infections Is An In Vitro Diagnostic Device Intended For The Detection And Identification Of Nucleic Acids From Non-viral Microorganism(s) In Clinical Specimens Collected From Patients Suspected Of Sexually Transmitted Infections. The Device Is Intended To Aid In The Diagnosis Of Non-viral Sexually Transmitted Infections In Conjunction With Other Clinical And Laboratory Data.
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 - QEP Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections

All 23
Devices cleared under the same product code (QEP) and FDA review panel - the closest regulatory comparables to K190441.
binx io CT/NG Assay and binx io CT/NG System
K200533 · Binx Health, Inc. · Apr 2020
Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay (Tigris) - 250 test kit, Aptima Trichomonas Vaginalis (Panther) - 250 test kit, Aptima Trichomonas Vaginalis (Tigris) - 250 test kit
K200436 · Hologic, Inc. · Mar 2020
binx health io CT/NG Assay
K191352 · Binx Health, Inc. · Aug 2019
Aptima Combo 2 Assay (Panther System)
K190515 · Hologic, Inc. · May 2019
cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas Buffer Negative Control Kit
K190433 · Roche Molecular Systems, Inc. · May 2019
Aptima Mycoplasma genitalium Assay
DEN180047 · Hologic, Inc. · Jan 2019