# K121539: Xpert GBS LB Genexpert DX Systems (GX-I, GX-IV) Genexpert DX Systems (GX-Xvi) Genexpert Infinity-48 System (900-XXXX)

- Pathway: 510(k) (Traditional)
- Applicant: Cepheid
- Decided: Nov 2, 2012 after 162 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: 4 generations back to K936112 (1994). 4 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K062948: Smart GBS and Smartcycle DX System and Software, Version 1.7B, Cepheid (2006) Summary page 1.

## Most influential descendants
- K203429: Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System (2022), 0 descendants of its own
- K181156: Panther Fusion GBS Assay (2018), 0 descendants of its own

## Indications for use
The Cepheid Xpert OBS LB Assay, performed on the Genepert@ Instrument Systems, is a qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) DNA from enriched vaginal/rectal swab specimens, using hilly automated real-time polymerase chain reaction (PCR) with fluorogenic detection of the amplified DNA. Xpert GBS LB Assay testing is indicated as an aid in determining GBS colonization status in antepartumn women. The Xpert GBS LB Assay is used for antepartumn testing on enriched im broth cultures of vaginal/rectal swabs after 18-24 hours of incubation. The Xpert GBS LB 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/K121539
Methodology: https://510kreport.com/methodology