# K170557: GenePOC GBS LB

- Pathway: 510(k) (Traditional)
- Applicant: Genepoc, Inc.
- Decided: May 25, 2017 after 90 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: 6 generations back to K936112 (1994). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111860: BD Max GBS Assay, BD Max Instrument, Becton, Dickinson & CO (2012) Summary page 6.

## Most influential descendants
- K182467: Simplexa GBS Direct, Simplexa GBS Positive Control Pack (2018), 0 descendants of its own

## Indications for use
The GenePOC™ GBS LB assay performed on the revogene™ instrument is a qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) DNA from 18-24 hour LIM broth enrichments of vaginal/rectal specimen swabs obtained from pregnant women. The GenePOC GBS LB assay utilizes automated sample processing and real-time polymerase chain reaction (PCR) to detect a cfb gene sequence specific to the Streptococcus agalactiae genome. The GenePOC GBS LB assay is indicated for the identification of antepartum GBS colonization and does not provide susceptibility results. It is not intended to diagnose or monitor treatment of GBS infection. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women.

Source page: https://510kreport.com/device/K170557
Methodology: https://510kreport.com/methodology