# OZZ: Bordetella Pertussis Dna Assay System

- Device class: 2; regulation: 21 CFR 866.3980; FDA's rule: 510(k) required
- FDA decisions: 9
- 510(k) review time 2021–2025: median 350 days (middle half 350–350)
- Recalls: 0 (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)
- 2014: 2
- 2015: 1
- 2017: 2
- 2018: 3
- 2025: 1

## Most-cited predicates
- K133673: Illumigene Pertusis Dna Amplification Assay, Illumigene Pertussis External Control Kit, Illumipro-10 Automated Isotherma (2014), cited by 3
- K163626: ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit (2017), cited by 1
- K173498: Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack (2018), cited by 1

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