Cleared Traditional

K111409 - APTIMA COMBO 2 ASSAY

K111409 is an FDA 510(k) clearance for APTIMA COMBO 2 ASSAY, manufactured by Gen-Probe, Inc.. The device is a Class 2 Microbiology device with product code LSL cleared through the Traditional 510(k) pathway after a 350-day FDA review.

K111409 · Gen-Probe, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
350d
Days
Class 2
Risk

K111409 is an FDA 510(k) clearance for the APTIMA COMBO 2 ASSAY. Classified as Dna-reagents, Neisseria (product code LSL), Class II - Special Controls.

Submitted by Gen-Probe, Inc. (San Diego, US). The FDA issued a Cleared decision on May 3, 2012 after a review of 350 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Gen-Probe, Inc. devices

FDA 510(k) Submission Details - K111409

510(k) Number K111409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2011
Decision Date May 03, 2012
Days to Decision 350 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
248d slower than avg
Panel avg: 102d · This submission: 350d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LSL Device Classification - Class 2, Special Controls

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 36
Devices cleared under the same product code (LSL) and FDA review panel - the closest regulatory comparables to K111409.
COBAS CT/NG V2.0 TEST
K140887 · Roche Molecular Systems, Inc. · May 2014
COBAS CT/NG V2.0 TEST
K132270 · Roche Molecular Systems, Inc. · Dec 2013
XPERT CT/NG
K121710 · Cepheid · Dec 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
BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY
K090827 · Becton, Dickinson & CO · May 2009