# K974503: Roche Amplicor CT/NG Test for Neisseria Gonorrhoeae

- Pathway: 510(k) (Traditional)
- Applicant: Roche Molecular Systems, Inc.
- Decided: Dec 1, 1999 after 733 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.
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
- K070172: Amplicor CT/NG Test for Neisseria Gonorrhoeae (2007), 0 descendants of its own

## Recalls of this device
- Jul 7, 2004 · Not classified · Z-1361-04: An increased frequency of 'blue foci' that potentially can cause elevated A450 background in microwell plate wells after the addition of conjugate reagent during PCR detection.

## Indications for use
The AMPLICOR® CT/NG Test for Neisseria gonorrhoeae is a qualitative in vitro test for the detection of Neisseria gonorrhoeae in clinical specimens. The test utilizes polymerase chain reaction (PCR) for the multiplex nucleic acid amplification of Neisseria gonorrhoeae and Chlamydia trachomatis DNA in endocervical and male urethral swab specimens and in male and female urine specimens from symptomatic and asymptomatic patients, and target-specific probe hybridization capture for the detection of the amplified Neisseria gonorrhoeae DNA.

Source page: https://510kreport.com/device/K974503
Methodology: https://510kreport.com/methodology