# PGX: Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System

- Device class: 2; regulation: 21 CFR 866.2680; FDA's rule: 510(k) required
- FDA decisions: 15
- Recalls: 2 (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: 3
- 2015: 3
- 2016: 1
- 2017: 2
- 2018: 2
- 2019: 1
- 2020: 1
- 2026: 2

## Most-cited predicates
- DEN140005: Lyra Direct Strep Assay (2014), cited by 6
- K141338: Liat Strep a Assay (2014), cited by 5
- K141757: Alere I Strep a (2015), cited by 2
- K143651: Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack (2015), cited by 1
- K173653: Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit (2018), cited by 1

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