# K112125: Illumigene Group B Streptococcus ,External Control Kit

- Pathway: 510(k) (Traditional)
- Applicant: Meridian Bioscience, Inc.
- Decided: Dec 5, 2011 after 133 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.
4 later devices descend from it; 3 cite it directly.
0 of 9 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
- K133503: Amplivue GBS Assay (2013), 1 descendant of its own
- K173250: Solana GBS Assay (2017), 0 descendants of its own
- K143312: Portrait GBS Assay (2015), 0 descendants of its own
- K121044: Illumigene Group B Streptococcus Carrot Broth Claim (2012), 0 descendants of its own

## Indications for use
The illumigene Group BStreptococcus (GBS) assay, performed on the illumnipro-IO™, is aqualitative in vitro diagnostic for the detection of Streptococcus ogoloctioe in enriched cultures obtained from vaginal/rectal swab specimens from antepartdmn women. Enriched cultures are obtained by 18 -24 hour incubation of vaginal/rectal swab specimens in selective broth medium, either Lim Broth [Todd Hewitt Broth supplemented with colistin (10 pg/mL) and nalidixic acid (15 pg/mt)] or TransVag Broth [Todd-Hewitt broth supplemented with gentamycin (8pg/mL) and nalidixic acid (15 The illumigene GBS assay utilizes loop-mediated isdithermal DNA amplification (LAMP) technology to detect Streptococcus ogoloctioe by targeting a segment of the Streptococcurs agoloctiae genome. Results from the iflumigene CBS assay can be used as an aid in establishing the CBS colonization status of antepartumn women. This assay is not intended to diagnose or monitor treatment for CBS infections. The iflumnigene CBS assay does not provide susceptibility results. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women. illumigene Group BStreptococcus 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/K112125
Methodology: https://510kreport.com/methodology