# K230451: Aptima® Chlamydia trachomatis Assay

- Pathway: 510(k) (Traditional)
- Applicant: Hologic, Inc.
- Decided: Nov 16, 2023 after 268 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: 1 generation back to K063451 (2007). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063451: Gen-Probe Aptima Assay for Chlamydia Trachomatis, Model 1199, Gen-Probe, Inc. (2007) Summary page 4.

## Indications for use
The Aptima Chlamydia trachomatis (CT) assay is an in vitro qualitative nucleic acid amplification test (NAAT) for the detection of ribosomal RNA (rRNA) from Chlamydia trachomatis to aid in the diagnosis of chlamydia urogenital disease using the Panther System. The assay may be used to test the following specimens from symptomatic or asymptomatic individuals: patient-collected vaginal swab specimens¹ (in a clinical setting); and female and male urine specimens. ¹Patient-collected vaginal swab specimens are an option for screening women when a pelvic exam is not otherwise indicated. The Aptima Multitest Swab Specimen Collection Kit has not been evaluated for home use.

Source page: https://510kreport.com/device/K230451
Methodology: https://510kreport.com/methodology