# K080739: Abbott Realtime CT/NG Assay and Multi-Collect Specimen Collection Kit

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Molecular, Inc.
- Decided: Jul 10, 2008 after 115 days
- Product code: MKZ (Dna Probe, Nucleic Acid Amplification, Chlamydia)
- Device class: 1
- Regulation: 21 CFR 866.3120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K003395 (2001). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 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 1.
- K012351: Bdprobetec ET CT/GC Amplified Dna Assay, Becton, Dickinson & CO (2001) Summary page 1.
- K043144: Gen-Probe Aptima Assay for Neisseria Gonorrhoeae, Gen-Probe, Inc. (2005) Summary page 1.
- K032554: Gen-Probe Aptima Combo 2 Assay, Gen-Probe, Inc. (2003) Summary page 1.
- K052224: BD Probe Tec Urine Preservative Transport, Becton, Dickinson & CO (2005) Summary page 1.

## Indications for use
The Abbott RealTime CT/NG assay is an in vitro polymerase chain reaction (PCR) assay for the direct, qualitative detection of the plasmid DNA of Chlamydia trachomatis and the genomic DNA of Neisseria gonorrhoeae. The assay may be used to test the following specimens from symptomatic individuals: clinician-collected vaginal swab and male urethral swab specimens; patient-collected vaginal swab specimens; and female and male urine specimens. The assay may be used to test the following specimens from asymptomatic individuals: male and female urine. The Abbott multi-Collect Specimen Collection Kit is intended for the collection and transportation of male and female swab and urine specimens for the detection of Chlamydia trachomatis and Neisseria gonorrhéac per instructions provided. Refer to the specimen collection procedure in the package insert for specimen collection instructions for specific sample types. Self-collected vaginal swab specimens are an option for screening women when a pelvic exam is not otherwise indicated. The Abbott multi-Collect Specimen Collection Kit is not intended for home use.

Source page: https://510kreport.com/device/K080739
Methodology: https://510kreport.com/methodology