# K043072: Gen-Probe Aptima Assay for Chlamydia Trachomatis

- Pathway: 510(k) (Traditional)
- Applicant: Gen-Probe, Inc.
- Decided: Jan 27, 2005 after 80 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) GEN-PROBE® APTIMA® Combo 2 Assay: named in the summary without a submission number
- (no number) Becton Dickenson ProbeTec ET System CT and CT/GC Assays: named in the summary without a submission number

## Indications for use
The APTIMA Assay for Chlamydia trachomatis is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection of ribosomal RNA (rRNA) from Chlamydia trachomatis (CT) in clinician-collected endocervical, vaginal and male urethral swab specimens, patient-collected vaginal swab specimens*, and female and male urine specimens. The assay may be used to test specimens from symptomatic and asymptomatic individuals to aid in the diagnosis of chlamydial urogenital disease. *Patient-collected vaginal swab specimens are an option for screening women when a pelvic exam is not otherwise indicated. The vaginal swab specimen collection kit is not for home use.

Source page: https://510kreport.com/device/K043072
Methodology: https://510kreport.com/methodology