# K092704: Abbott Realtime CT/NG and Abbott Multi-Collect Specimen Collection Kit, Models 8L07-91, 9K12-03

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Molecular, Inc.
- Decided: May 28, 2010 after 267 days
- Product code: LSK (Dna-Reagents, Chlamydia)
- Device class: 1
- Regulation: 21 CFR 866.3120
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to P950039 (1996). 4 ancestors in all.
11 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043224: Gen-Probe Aptima Combo 2 Assay, Gen-Probe, Inc. (2005) Summary page 4.
- K012351: Bdprobetec ET CT/GC Amplified Dna Assay, Becton, Dickinson & CO (2001) Summary page 4.

## Most influential descendants
- K110923: Cobas 4800 CT / NG Test (2012), 10 descendants of its own
- 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

## Recalls of this device
- Dec 20, 2010 · Not classified · Z-1397-2011: Internal testing identified the potential of under filled and over filled enzyme reagent vials which may result in obtaining less than the total number of tests per kit as described on the package ins

## Indications for use
The Abbott RealTimne CT/NO (List No. 8L07-9l1) assay is anl in vitro polyrnerase chain reaction (PCR) assay for the direct, qualitative detection of the plasmid DNA of Chlamydia trachomatis and thle genomic DNA of Neisseria gonorrhoeae. The assay may be used to test thle following specimens from symptomatic individuals: female endocervical swab, clinician-collected vaginal swab, and patient-collected vaginal swab specimens; male urethral swab specimens; and female and male urine specimens. The assay may be used to test the following specirriens from asymptornatic individuals: clinician-collected vagina! swab and patient-collected vaginal swab specimens; female and male~urine specimens.

Source page: https://510kreport.com/device/K092704
Methodology: https://510kreport.com/methodology