# K133503: Amplivue GBS Assay

- Pathway: 510(k) (Traditional)
- Applicant: Quidel Corporation
- Decided: Dec 20, 2013 after 36 days
- Product code: NJR (Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test)
- Device class: 1
- Regulation: 21 CFR 866.3740
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K936112 (1994). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112125: Illumigene Group B Streptococcus ,External Control Kit, Meridian Bioscience, Inc. (2011) Summary page 4.

## Most influential descendants
- K173250: Solana GBS Assay (2017), 0 descendants of its own

## Indications for use
The AmpliVue® GBS Assay is a qualitative in vitro diagnostic test for the rapid detection of Group B Streptococcus from vaginal/rectal swabs from antepartum women following 18 to 24 hours of incubation in an LIM enrichment broth culture. The AmpliVue® GBS Assay utilizes helicase-dependent amplification (HDA) of the Thiolase (atoB) gene sequence and a self-contained disposable amplification detection device that allows for manual evaluation of assay results. Results can be used as an aid in determining the colonization status of antepartum women. The AmpliVue® GBS Assay does not provide susceptibility results. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women. The AmpliVue® GBS Assay is intended for use in hospital, reference or state laboratory settings. The device is not intended for point-of-care use.

Source page: https://510kreport.com/device/K133503
Methodology: https://510kreport.com/methodology