# NJR: Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test

- Device class: 1; regulation: 21 CFR 866.3740; FDA's rule: 510(k) exempt
- FDA decisions: 18
- 510(k) review time 2021–2025: median 463 days (middle half 427–499)
- Recalls: 9 (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)
- 2010: 1
- 2011: 1
- 2012: 3
- 2013: 1
- 2015: 1
- 2016: 1
- 2017: 2
- 2018: 3
- 2022: 1
- 2023: 1

## Most-cited predicates
- K062948: Smart GBS and Smartcycle DX System and Software, Version 1.7B (2006), cited by 4
- K112125: Illumigene Group B Streptococcus ,External Control Kit (2011), cited by 3
- K090191: Handylab GBS Assay, Handylab Jaguar Instrument, Handylab Dna Extraction Strip, Handylab E3 Extraction Reagent, Handylab (2010), cited by 2
- K022504: Idi-Strep B Assay (2002), cited by 2
- K121539: Xpert GBS LB Genexpert DX Systems (GX-I, GX-IV) Genexpert DX Systems (GX-Xvi) Genexpert Infinity-48 System (900-XXXX) (2012), cited by 2
- K170557: GenePOC GBS LB (2017), cited by 1
- K060540: Xpert, Genexpert DX System (2006), cited by 1
- K133503: Amplivue GBS Assay (2013), cited by 1
- K111860: BD Max GBS Assay, BD Max Instrument (2012), cited by 1

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