# K060540: Xpert, Genexpert DX System

- Pathway: 510(k) (Traditional)
- Applicant: Cepheid
- Decided: Jul 25, 2006 after 146 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K936112 (1994). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022504: Idi-Strep B Assay, Infectio Diagnostic, Inc. (2002) Summary page 1.

## Most influential descendants
- K222638: Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems (2023), 0 descendants of its own

## Recalls of this device
- Sep 5, 2007 · Not classified · Z-0376-2008: Labeling Error: Some cartridges may be mislabeled as "Xpert EV" instead of "Xpert GBS". (The information embedded in the barcode label on the cartridge is correct for Xpert GBS and brings up the GBS a

## Indications for use
The Cepheid Xpert GBS performed on the GeneXpert Dx System is a qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) DNA from vaginal/rectal swab specimens, using fully automated real-time polymerase chain reaction (PCR) with fluorogenic detection of the amplified DNA. Xpert GBS Assay testing is indicated for rapid identification of antepartum and intrapartum GBS colonization. * The use of the Xpert GBS for intrapartum screening should not preclude the use of other strategies (e.g., antepartum testing). Intrapartum Xpert GBS results are useful to identify candidates for intrapartum antibiotic prophylaxis when administration of intravenous antibiotics is not delayed pending results. * The Xpert 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/K060540
Methodology: https://510kreport.com/methodology