# K962217: Gen-Probe Amplified Chlamydia Trachomatis Assay Kit

- Pathway: 510(k) (Traditional)
- Applicant: Gen-Probe, Inc.
- Decided: Nov 27, 1996 after 170 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) tissue culture media and components: named in the summary without a submission number

## Indications for use
The GEN-PROBE AMPLIFIED Chlamydia Trachomatis Assay (AMP CT) Kit is a target-amplified nucleic acid probe test used for the in vitro diagnostic qualitative detection of rRNA from Chlamydia trachomatis in endocervical and male urethral swab specimens and in female and male urine specimens.

Source page: https://510kreport.com/device/K962217
Methodology: https://510kreport.com/methodology