# K053289: Cobas Amplicor CT/NG Test for Neisseria Gonorrhoeae

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Aug 10, 2006 after 258 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
Longest line of descent: 1 generation back to K974342 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974342: Roche Cobas Amplicor CT/NG Test for Neisseria Gonorrhoeae, Roche Molecular Systems, Inc. (1999) Summary page 2.

## Indications for use
The Roche Scripts for COBAS AMPLICOR CT/NG Test are intended to provide software scripts to direct the automated Tecan Genesis RSP 150 Workstation to process swab samples or control material for analysis using either of the following 510(k)-cleared assay test systems: COBAS AMPLICOR™ CT/NG test for Chlamydia trachomatis COBAS AMPLICOR™ CT/NG test for Neisseria gonorrhoeae

Source page: https://510kreport.com/device/K053289
Methodology: https://510kreport.com/methodology