# MKZ: Dna Probe, Nucleic Acid Amplification, Chlamydia

- Device class: 1; regulation: 21 CFR 866.3120; FDA's rule: 510(k) required
- FDA decisions: 19
- 510(k) review time 2021–2025: median 268 days (middle half 268–268)
- Recalls: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1998: 1
- 1999: 1
- 2005: 1
- 2006: 3
- 2007: 2
- 2008: 2
- 2009: 2
- 2012: 1
- 2014: 1
- 2023: 1

## Most-cited predicates
- K110923: Cobas 4800 CT / NG Test (2012), cited by 3
- K081824: BD Probetec Chlamydia Trachomatis (CT) Q Amplified Dna Assay (2008), cited by 3
- K091724: BD Probetec Chlamydia Trachomatis (CT) Q Amplified Dna Assay (2009), cited by 2
- K922906: Amplicor Chlamydia Trachomatis Test (1993), cited by 2
- K973718: Roche Cobas Amplicor CT/NG Test for Chlamydia Trachomatis (1998), cited by 1
- K934622: LCX Chlamydia Trachomatis Assay (1995), cited by 1
- K063451: Gen-Probe Aptima Assay for Chlamydia Trachomatis, Model 1199 (2007), cited by 1
- K053446: Gen-Probe Aptima Assay for Chlamydia Trachomatis, Model 1088 (2006), cited by 1
- K973707: Roche Amplicor CT/NG Test for Chlamydia Trachomatis (1999), cited by 1

Source page: https://510kreport.com/product-code/MKZ
Data by year (CSV): https://510kreport.com/product-code/MKZ.csv