# K132251: Aptima Combo 2 Assay (Panther System)

- Pathway: 510(k) (Traditional)
- Applicant: Hologic / Gen-Probe Incorporated
- Decided: Oct 17, 2013 after 90 days
- Product code: LSL (Dna-Reagents, Neisseria)
- Device class: 2
- Regulation: 21 CFR 866.3390
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K032194 (2003). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111409: Aptima Combo 2 Assay, Gen-Probe, Inc. (2012) Summary page 5.

## Recalls of this device
- Jan 20, 2018 · Class II · Z-0595-2018: The Panther or the Panther Fusion glass panel separates from the 19 inch touch screen monitor and could potentially fall and hit an operator.
- Sep 15, 2017 · Class II · Z-0027-2018: An incorrect incubator was installed on one Panther System which potentially led to incorrect Aptima Combo 2(R) assay (AC2) results.

## 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 Chlinydia irachomatis (CT) and/or Neisseria gonorrhoeae (OC) to aid in the diagnosis of chiamydial and/or gonococcal urogenital disease using the PANTHER System as specified. On the PANTHER Systentthe assay may be used to test the following specimens from symptomatic and asymptomatic individuals: clinician-collected endocervical, vaginal and male urethral swab specimens, clinician-collected gynecological specimens collected in the PreservCyt Solution, patient-collected vaginal swab specimens,] and male urine specimens. Patient-collected vaginal swab specimens are an option for screening women when a pelvic examt is not otherwise indicated. The vaginal swab specimen collection kit is not for home use.

Source page: https://510kreport.com/device/K132251
Methodology: https://510kreport.com/methodology