# DEN180047: Aptima Mycoplasma genitalium Assay

- Pathway: De Novo (Direct)
- Applicant: Hologic, Inc.
- Decided: Jan 23, 2019 after 145 days
- Product code: QEP (Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections)
- Device class: 2
- Regulation: 21 CFR 866.3393
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
12 later devices descend from it; 4 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K190515: Aptima Combo 2 Assay (Panther System) (2019), 6 descendants of its own
- K190433: cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas Buffer Negative Control Kit (2019), 3 descendants of its own
- K200436: Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay (Tigris) - 250 test kit, Aptima Trichomonas Vaginalis (Panther) - 250 test kit, Aptima Trichomonas Vaginalis (Tigris) - 250 test kit (2020), 2 descendants of its own
- K202977: Alinity m STI Assay (2022), 1 descendant of its own
- K200866: Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System) (2020), 1 descendant of its own

## Indications for use
The Aptima Mycoplasma genitalium assay is an in vitro nucleic acid amplification test (NAAT) for the qualitative detection of ribosomal RNA (rRNA) from Mycoplasma genitalium on the fully automated Panther system. It is intended for use as an aid in the diagnosis of M. genitalium urogenital infections in male and female patients suspected of M. genitalium infection. The assay may be used to test the following specimens: clinician-collected and self-collected vaginal swabs (in a clinical setting), clinician-collected endocervical swabs, female and male urine, clinician-collected male urethral swabs, and self-collected penile meatal swabs (in a clinical setting). For females, a vaginal swab is the preferred specimen type due to higher clinical sensitivity for detecting M. genitalium than other specimen types; however, female urine or clinician-collected endocervical swabs may be used as alternative specimens when vaginal swab specimens are not available. If female urine or clinician-collected endocervical swab specimens test negative, testing with a vaginal swab may be indicated, if M. genitalium infection is suspected.

Source page: https://510kreport.com/device/DEN180047
Methodology: https://510kreport.com/methodology