# K162772: ARIES GBS Assay

- Pathway: 510(k) (Traditional)
- Applicant: Luminex Corporation
- Decided: Dec 23, 2016 after 81 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: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Feb 20, 2019 · Class II · Z-2285-2019: Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially sealed SCAs. The impa
- Jun 29, 2018 · Class II · Z-2292-2019: An incorrect control board and firmware installed in some of the Hand Held Barcode Scanners could result in sample/patient mismatch or duplicate results (from other patients specimens) for a patient o
- Apr 19, 2017 · Class II · Z-2094-2017: The hand-held barcode scanner that is used as an accessory to enter ARIES cassette and specimen identifications on the ARIES Systems populates patient sample IDs with a previously scanned sample ID wh

## Indications for use
The ARIES GBS Assay, performed on ARIES Systems, is a real-time polymerase chain reaction (RT-PCR) based qualitative in vitro diagnostic test. The ARIES GBS Assay is designed to detect Group B Streptococcus (GBS) nucleic acid from 18-24 hour Lim broth enrichments of vaginal-rectal specimen swabs obtained from pregnant women. The ARIES GBS Assay is intended for use as a method for detection of GBS colonization in antepartum women. It is not intended to diagnose or monitor treatment of a GBS infection. The ARIES 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/K162772
Methodology: https://510kreport.com/methodology