Cleared Traditional

GEN-PROBE APTIMA COMBO 2 ASSAY

K043224 · Gen-Probe, Inc. · Microbiology
Aug 2005
Decision
260d
Days
Class 2
Risk

About This 510(k) Submission

K043224 is an FDA 510(k) clearance for the GEN-PROBE APTIMA COMBO 2 ASSAY, a Dna-reagents, Neisseria (Class II — Special Controls, product code LSL), submitted by Gen-Probe, Inc. (San Diego, US). The FDA issued a Cleared decision on August 9, 2005, 260 days after receiving the submission on November 22, 2004. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3390.

Submission Details

510(k) Number K043224 FDA.gov
FDA Decision Cleared SESE
Date Received November 22, 2004
Decision Date August 09, 2005
Days to Decision 260 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

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

Similar Devices — LSL Dna-reagents, Neisseria

All 44
Aptima Neisseria gonorrhoeae Assay
K231329 · Hologic, Inc. · Jan 2024
Aptima Combo 2 Assay (Panther System)
K180681 · Hologic, Inc. · Jun 2018
cobas CT/NG for use on cobas 6800/8800 systems
K173887 · Roche Molecular Systems, Inc. · Mar 2018
Xpert CT/NG
K173840 · Cepheid · Mar 2018
cobas? CT/NG v2.0 Test
K163184 · Roche Molecular Systems, Inc. · Feb 2017
BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY
K140448 · Becton, Dickinson & CO · May 2014