# K964507: Roche Cobas Amplicor Chlamydia Trachomatis Test

- Pathway: 510(k) (Traditional)
- Applicant: Roche Molecular Systems, Inc.
- Decided: Jun 13, 1997 after 217 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 K922906 (1993). 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)
- K922906: Amplicor Chlamydia Trachomatis Test, Roche Molecular Systems, Inc. (1993) Summary page 1.

## Indications for use
The COBAS AMPLICOR™ Chlamydia trachomatis Test is a qualitative in vitro diagnostic test for the detection of Chlamydia trachomatis in clinical specimens on the COBAS AMPLICOR analyzer. The test utilizes the Polymerase Chain Reaction (PCR) nucleic acid amplification technique and nucleic acid hybridization for the detection of Chlamydia trachomatis plasmid DNA in endocervical, male urethral, and male urine samples.

Source page: https://510kreport.com/device/K964507
Methodology: https://510kreport.com/methodology