# K220321: Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 Assay (250 test kit) Tigris, Aptima Trichomonas Vaginalis Assay (250 test kit) Panther, Aptima Trichomonas Vaginalis Assay (250 test kit) Tigris

- Pathway: 510(k) (Special)
- Applicant: Hologic, Inc.
- Decided: Jun 3, 2022 after 120 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: 4 generations back to DEN110012 (2011). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200866: Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System), Hologic, Inc. (2020) Summary page 5.
- K122062: Aptima Trichomonas Vaginalis Assay - Panther, Gen-Probe, Inc. (2013) Summary page 5.
- DEN110012: Aptima Trichomonas Vaginalis Assay, Gen-Probe Incorporated (2011). Our reading of the summary gave K102911, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN110012, Aptima Trichomonas Vaginalis Assay (Gen-Probe Incorporated), granted Apr 19, 2011; older De Novo requests were first filed under a 510(k) number, so this links to the grant.

## 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, PreservCyt Solution liquid Pap specimens, vaginal, throat, rectal, and male urethral swab specimens; patient collected vaginal swab specimens1, 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. 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 urogenital disease using the Tigris DTS Automated Analyzer. The assay may be used to test the following specimens from symptomatic individuals: clinician-collected endocervical, vaginal and male urethral swab specimens; and female and male urine specimens. The assay may be used to test the following specimens from asymptomatic individuals: clinician-collected endocervical, vaginal and male urethral swab specimens; patient-collected vaginal swab specimens1; and female and male urine specimens. The assay is also intended for use with the testing of gynecological specimens, from both symptomatic and asymptomatic patients, collected in the PreservCyt Solution. 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 is not for home use. The Aptima Trichomonas vaginalis Assay is an in vitro qualitative nucleic acid amplification test (NAAT) for the detection of ribosomal RNA (rRNA) from Trichomonas vaginalis to aid in the diagnosis of trichomoniasis using the Panther System. The assay may be used to test the following specimens from symptomatic or asymptomatic women: clinician-collected endocervical swabs, clinician-collected vaginal swabs, and specimens collected in PreservCyt Solution. The Aptima Trichomonas vaginalis Assay is an in vitro qualitative nucleic acid amplification test (NAAT) for the detection of ribosomal RNA (rRNA) from Trichomonas vaginalis to aid in the diagnosis of trichomoniasis using the Tigris DTS System. The assay may be used to test the following specimens from symptomatic or asymptomatic women: clinician-collected endocervical swabs, clinician-collected vaginal swabs, female urine specimens, and specimens collected in PreservCyt Solution.

Source page: https://510kreport.com/device/K220321
Methodology: https://510kreport.com/methodology