# K974572: Gen-Probe Accuprobe Group B Streptococcus Culture Identification Test 2820

- Pathway: 510(k) (Traditional)
- Applicant: Chugai Pharmaceuticals Co., Ltd.
- Decided: Sep 24, 1998 after 293 days
- Product code: MDK (Dna-Probe, Reagents, Streptococcal)
- Device class: 1
- Regulation: 21 CFR 866.3740
- Recalls of this device: 2 (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. The FDA summary names no predicate by number.

## Recalls of this device
- Dec 30, 2008 · Not classified · Z-1436-2011: This recall has been initiated following the identification of certain assay tubes that do not contain probe reagent. The affected kits may contain a combination of tubes with correct probe amount, pa
- May 2, 2007 · Not classified · Z-0145-2008: Mispackaging: Kits may contain Haemophilus Influenza probe pouches in addition to Group B Streptococcus probe pouches

## Indications for use
The AccuProbe Group B Streptococcus Culture Identification Test is a rapid DNA probe test which utilizes the technique of nucleic acid hybridization for the identification of Group B Streptococcus isolated from culture. The new indication for use covered in this 510(k) is for culture identification of Group B Streptococcus from vaginal and/or anorectal swab specimens collected from pregnant women at 35 to 37 weeks gestation, and cultured in Lim broth for 18 to 24 hours.

Source page: https://510kreport.com/device/K974572
Methodology: https://510kreport.com/methodology