# K974342: Roche Cobas Amplicor CT/NG Test for Neisseria Gonorrhoeae

- Pathway: 510(k) (Traditional)
- Applicant: Roche Molecular Systems, Inc.
- Decided: May 28, 1999 after 556 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K053289: Cobas Amplicor CT/NG Test for Neisseria Gonorrhoeae (2006), 0 descendants of its own

## Indications for use
The COBAS AMPLICOR CT/NG Test for Neisseria gonorrhoeae is a qualitative in vitro test for the detection of N. gonormhoeae 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 of infection with N. gonormhoeae. N. gonormhoeae DNA is detected by Polymerase Chain Reaction (PCR) amplification of target DNA and by hybridization capture of amplified target using the COBAS AMPLICOR Analyzer.

Source page: https://510kreport.com/device/K974342
Methodology: https://510kreport.com/methodology