Cleared Traditional

K121710 - XPERT CT/NG

K121710 is the FDA 510(k) clearance for XPERT CT/NG by Cepheid. It is a Class 2 Microbiology device (product code LSL) cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K121710 · Cepheid · Microbiology device
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Dec 2012
Decision
199d
Days
Class 2
Risk

K121710 is an FDA 510(k) clearance for the XPERT CT/NG. Classified as Dna-reagents, Neisseria (product code LSL), Class II - Special Controls.

Submitted by Cepheid (Sunnyvale, US). The FDA issued a Cleared decision on December 27, 2012 after a review of 199 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3390 - 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 Cepheid devices

Submission Details

510(k) Number K121710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2012
Decision Date December 27, 2012
Days to Decision 199 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
97d slower than avg
Panel avg: 102d · This submission: 199d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LSL Dna-reagents, Neisseria
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3390
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 - LSL Dna-reagents, Neisseria

All 35
Devices cleared under the same product code (LSL) and FDA review panel - the closest regulatory comparables to K121710.
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COBAS CT/NG V2.0 TEST
K132270 · Roche Molecular Systems, Inc. · Dec 2013
APTIMA COMBO 2 ASSAY
K111409 · Gen-Probe, Inc. · May 2012
BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY
K091730 · Becton, Dickinson & CO · Nov 2009
BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY
K090971 · Becton, Dickinson & CO · Jun 2009