# K143312: Portrait GBS Assay

- Pathway: 510(k) (Traditional)
- Applicant: Great Basin Corporation
- Decided: Apr 21, 2015 after 154 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: 5 generations back to K936112 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112125: Illumigene Group B Streptococcus ,External Control Kit, Meridian Bioscience, Inc. (2011) Summary page 4.

## Indications for use
The Great Basin Portrait™ GBS Assay, performed on the PA500 Portrait™ Analyzer System, is a qualitative in vitro diagnostic test (IVD) for the detection of Group B Streptococcus (GBS) DNA from vaginal/rectal swabs from antepartum women, following enrichment in LIM Broth for 18 - 29 hours. The assay utilizes automated sample preparation and polymerase chain reaction (PCR) to amplify a cfb gene sequence specific to the Streptococcus agalactiae (GBS) genome which is detected by hybridization probes immobilized on a silica chip surface. Results from the Portrait™ GBS Assay can be used as an aid in determining colonization status in antepartum women. The Portrait™ GBS Assay does not provide susceptibility results. Cultured isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women. The Portrait™ GBS Assay is intended for use in clinical laboratory, hospital laboratory, and reference laboratory settings. The Portrait™ GBS Assay is not intended for point of care use.

Source page: https://510kreport.com/device/K143312
Methodology: https://510kreport.com/methodology