# K070174: Amplicor CT/NG Test for Chlamydia Trachomatis; Roche Scripts for CT/NG Test Accessory

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corporation
- Decided: Apr 16, 2007 after 88 days
- Product code: MKZ (Dna Probe, Nucleic Acid Amplification, Chlamydia)
- Device class: 1
- Regulation: 21 CFR 866.3120
- 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 K973707 (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)
- K973707: Roche Amplicor CT/NG Test for Chlamydia Trachomatis, Roche Molecular Systems, Inc. (1999) Summary page 2.

## Indications for use
The AMPLICOR CT/NG test for Chlamydia trachomatisis a qualitative in vitro test for the detection of C. trachomatis DNA in urine from symptomatic or asymptomatic males, in endocervical swab specimens from symptomatic or asymptomatic females, and in urethral swab specimens from symptomatic males as evidence infection with C. trachomatis. C. trachomatisDNA is detected by Polymerase Chain Reaction (PCR) amplification of target DNA and by hybridization capture of amplified target. Sample and control preparation can either be accomplished manually or automated using the optional Roche Scripts for AMPLICOR CT/NG Test accessory to direct the Tecan Genesis RSP 150 workstation. Urine specimens are not indicated for use with the automated sample preparation option. The Roche Scripts for 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 four 510(k)-cleared assay test systems: * AMPLICOR ® CT/NG test for Chlamydia trachomatis * AMPLICOR ® CT/NG test for Neisseria gonorrhoeae

Source page: https://510kreport.com/device/K070174
Methodology: https://510kreport.com/methodology