# K973707: Roche Amplicor CT/NG Test for Chlamydia Trachomatis

- Pathway: 510(k) (Traditional)
- Applicant: Roche Molecular Systems, Inc.
- Decided: Aug 4, 1999 after 674 days
- Product code: MKZ (Dna Probe, Nucleic Acid Amplification, Chlamydia)
- Device class: 1
- Regulation: 21 CFR 866.3120
- 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
- K070174: Amplicor CT/NG Test for Chlamydia Trachomatis; Roche Scripts for CT/NG Test Accessory (2007), 0 descendants of its own

## Recalls of this device
- Jul 7, 2004 · Not classified · Z-1360-04: 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 Chlamydia trachomatis is a qualitative in vitro test for the detection of Chlamydia trachomatis plasmid DNA in urine from males and females, in endocervical swab specimens from symptomatic or asymptomatic females, and in urethral swab specimens as evidence of symptomatic or asymptomatic infection with Chlamydia trachomatis. Chlamydia trachomatis DNA is detected by Polymerase Chain Reaction (PCR) amplification of target DNA and by hybridization capture of amplified target and by hybridization capture of the amplified target.

Source page: https://510kreport.com/device/K973707
Methodology: https://510kreport.com/methodology