# K181156: Panther Fusion GBS Assay

- Pathway: 510(k) (Traditional)
- Applicant: Diagenode
- Decided: Jul 27, 2018 after 87 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: 2 (0 Class I)
- 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.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121539: Xpert GBS LB Genexpert DX Systems (GX-I, GX-IV) Genexpert DX Systems (GX-Xvi) Genexpert Infinity-48 System (900-XXXX), Cepheid (2012) Summary page 7.

## Recalls of this device
- Dec 13, 2024 · Class II · Z-0907-2025: Potential weak pouch seal on Panther Fusion GBS assay cartridge, causing potential for invalid or incorrect results leading to a possible delay of treatment.
- Mar 18, 2022 · Class II · Z-0877-2022: Samples, run on a GBS Assay, that have analyte concentrations that are at or near the limit of detection may produce false negative results.

## Indications for use
The Panther Fusion GBS assay is an automated qualitative in vitro diagnostic test utilizing real-time PCR for detection of Group B Streptococcus DNA from either Lim or Carrot enrichment broth cultures of vaginal/rectal swabs from antepartum women following 18-24 hours incubation. This test is performed on the Hologic Panther Fusion system and is intended to aid in determining the GBS colonization status of antepartum women. This assay does not diagnose or monitor treatment for GBS infections. The Panther Fusion GBS assay does not provide susceptibility results. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women.

Source page: https://510kreport.com/device/K181156
Methodology: https://510kreport.com/methodology