# K110923: Cobas 4800 CT / NG Test

- Pathway: 510(k) (Traditional)
- Applicant: Roche Molecular Systems, Inc.
- Decided: Jan 24, 2012 after 298 days
- Product code: MKZ (Dna Probe, Nucleic Acid Amplification, Chlamydia)
- Device class: 1
- Regulation: 21 CFR 866.3120
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K003395 (2001). 10 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060652: Tigris DTS Gen-Probe Aptima Combo 2 Assay, Gen-Probe, Inc. (2006) Summary page 1.
- K091724: BD Probetec Chlamydia Trachomatis (CT) Q Amplified Dna Assay, Becton, Dickinson & CO (2009) Summary page 1.
- K091730: BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified Dna Assay, Becton, Dickinson & CO (2009) Summary page 1.
- K092704: Abbott Realtime CT/NG and Abbott Multi-Collect Specimen Collection Kit, Models 8L07-91, 9K12-03, Abbott Molecular, Inc. (2010) Summary page 1.

## Most influential descendants
- K132270: Cobas CT/NG V2.0 Test (2013), 9 descendants of its own
- K163184: cobas® CT/NG v2.0 Test (2017), 7 descendants of its own
- K173887: cobas CT/NG for use on cobas 6800/8800 systems (2018), 6 descendants of its own
- K202408: cobas CTNG for use on cobas 6800/8800 systems (2021), 3 descendants of its own
- K260917: cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems (2026), 0 descendants of its own

## Recalls of this device
- Jan 6, 2014 · Class II · Z-1111-2014: Numerous complaints have been filed that leaking cobas ¿ PCR media 4.3 mL IVD have been received from different lots of the cobas ¿ PCR Urine kits, cobas ¿ PCR Female Swab kits, and cobas ¿ PCR media 
- Mar 1, 2013 · Class II · Z-1028-2013: Certain lots of Reagent reservoirs, may not have a separation in the lower part of the reservoir. As a consequence, pipetting errors can occur due to uneven distribution of reagent. These pipetting er

## Indications for use
The cobas® CT/NG Test is an in vitro nucleic acid amplification test that utilizes Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the qualitative detection of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) DNA to aid in the diagnosis of chlamydial and gonococcal disease. The test may be used with vaginal swab specimens self-collected in a clinical setting and male urine from both symptomatic and asymptomatic individuals. Specimens to be tested should be collected in cobas® PCR Media. The cobas® PCR Female Swab Sample Kit is used to collect and transport self-collected vaginal swab specimens in a clinical setting. The cobas® PCR Media serves as a nucleic acid stabilizing transport and storage medium for gynecological specimens. Use this collection kit only with the cobas® CT/NG Test. NOTE: This collection kit should not be used for collection of alternative gynecological specimens. The cobas® PCR Urine Sample Kit is used to collect and transport male urine specimens. The cobas® PCR Media serves as a nucleic acid stabilizing transport and storage medium for urine specimens. Use this collection kit only with the cobas® CT/NG Test. NOTE: This collection kit should not be used for collection of female urine specimens.

Source page: https://510kreport.com/device/K110923
Methodology: https://510kreport.com/methodology