# K190515: Aptima Combo 2 Assay (Panther System)

- Pathway: 510(k) (Traditional)
- Applicant: Hologic, Inc.
- Decided: May 23, 2019 after 83 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
Longest line of descent: 1 generation back to DEN180047 (2019). 1 ancestor in all.
6 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN180047: Aptima Mycoplasma genitalium Assay, Hologic, Inc. (2019) Summary page 3.

## Most influential descendants
- 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
- K230267: NeuMoDx CT/NG Assay 2.0 (2023), 0 descendants of its own
- K222379: Alinity m STI Assay (2023), 0 descendants of its own

## Indications for use
The Aptima Combo 2® Assay is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection and differentiation of ribosomal RNA (rRNA) from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) to aid in the diagnosis of chlamydial and/or gonococcal disease using the Panther® System as specified. On the Panther System, the assay may be used to test the following specimens from symptomatic and asymptomatic individuals: clinician-collected endocervical, vaginal, throat, rectal and male urethral swab specimens, clinician-collected gynecological specimens collected in the PreservCyt® Solution, patient-collected vaginal swab specimens, and female and male urine specimens.

Source page: https://510kreport.com/device/K190515
Methodology: https://510kreport.com/methodology