# K032194: Tigris DTS Automated Analyzer for Automating Amplified Nucleic Acid Test Assays

- Pathway: 510(k) (Traditional)
- Applicant: Gen-Probe, Inc.
- Decided: Dec 24, 2003 after 159 days
- Product code: LSL (Dna-Reagents, Neisseria)
- Device class: 2
- Regulation: 21 CFR 866.3390
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K111409: Aptima Combo 2 Assay (2012), 1 descendant of its own
- K132251: Aptima Combo 2 Assay (Panther System) (2013), 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 and/or Neisseria gonorrhoeae in endocervical and male urethral swab specimens, and in female and male urine specimens. The assay may be used to test specimens from symptomatic and asymptomatic individuals to aid in the diagnosis of gonococcal and/or chlamydial urogenital disease using the TIGRIS DTS Automated Analyzer or semi-automated instrumentation as specified.

Source page: https://510kreport.com/device/K032194
Methodology: https://510kreport.com/methodology