# K062948: Smart GBS and Smartcycle DX System and Software, Version 1.7B

- Pathway: 510(k) (Traditional)
- Applicant: Cepheid
- Decided: Dec 8, 2006 after 71 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: 3 generations back to K936112 (1994). 3 ancestors in all.
14 later devices descend from it; 4 cite it directly.
0 of 18 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
- K112125: Illumigene Group B Streptococcus ,External Control Kit (2011), 4 descendants of its own
- K090191: Handylab GBS Assay, Handylab Jaguar Instrument, Handylab Dna Extraction Strip, Handylab E3 Extraction Reagent, Handylab (2010), 4 descendants of its own
- K121539: Xpert GBS LB Genexpert DX Systems (GX-I, GX-IV) Genexpert DX Systems (GX-Xvi) Genexpert Infinity-48 System (900-XXXX) (2012), 2 descendants of its own
- K111860: BD Max GBS Assay, BD Max Instrument (2012), 2 descendants of its own
- K170557: GenePOC GBS LB (2017), 1 descendant of its own

## Indications for use
The Ccpheid Smart GBS Assay performed on the Cepheid SmartCycler Dx System is a qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) DNA from vaginal/rectal swab specimens and Lim broth cultures. The test utilizes real-time polymerase chain reaction (PCR) for a unique gene-specific sequence amplification of Streptococcus agalactiaerecovered from clinical samples and fluorogenic target specific hybridization for the detection of the amplified DNA. Results from the Smart GBS Assay are intended for use as a method for rapid detection of GBS colonization in antepartum and intrapartum women. * The use of the Smart GBS for intrapartum screening should not preclude the use of other strategies (e.g., antepartum testing). Intrapartum Smart GBS results are useful to identify candidates for intrapartum antibiotic prophylaxis when administration of intravenous antibiotics is not delayed pending results. * The Smart 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/K062948
Methodology: https://510kreport.com/methodology