# K003395: Gen-Probe Aptima Combo 2 Assay

- Pathway: 510(k) (Traditional)
- Applicant: Gen-Probe, Inc.
- Decided: May 21, 2001 after 201 days
- Product code: LSL (Dna-Reagents, Neisseria)
- Device class: 2
- Regulation: 21 CFR 866.3390
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
42 later devices descend from it; 4 cite it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K081825: BD Probetec Neisseria Gonorrhoeae (GC) Q Amplified Dna Assay (2008), 26 descendants of its own
- K043224: Gen-Probe Aptima Combo 2 Assay (2005), 21 descendants of its own
- K091724: BD Probetec Chlamydia Trachomatis (CT) Q Amplified Dna Assay (2009), 13 descendants of its own
- K091730: BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified Dna Assay (2009), 13 descendants of its own
- K092704: Abbott Realtime CT/NG and Abbott Multi-Collect Specimen Collection Kit, Models 8L07-91, 9K12-03 (2010), 11 descendants of its own

## Recalls of this device
- Apr 17, 2014 · Class III · Z-1793-2014: Incorrect labeling was used on each pouch of the affected lots of APTIMA Urine Specimen Collection Kits. The outer box of the kits are identified correctly as "APTIMA Urine Collection Kits"; however, 

Source page: https://510kreport.com/device/K003395
Methodology: https://510kreport.com/methodology