# K844407: Directigen Neissena Menningitidis Group B Test

- Pathway: 510(k) (Traditional)
- Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decided: Jan 25, 1985 after 73 days
- Product code: GTJ (Antisera, All Groups, N. Meningitidis)
- Device class: 2
- Regulation: 21 CFR 866.3390
- Recalls of this device: 4 (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 has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Sep 6, 2007 · Not classified · Z-1559-2008: Exhibits cross reactivity with Neisseria meningitides Group W135.
- Sep 6, 2007 · Not classified · Z-1560-2008: Exhibits cross reactivity with Neisseria meningitides Group W135.
- Sep 6, 2007 · Not classified · Z-1561-2008: Exhibits cross reactivity with Neisseria meningitides Group W135
- Sep 6, 2007 · Not classified · Z-1562-2008: Exhibits cross reactivity with Neisseria meningitides Group W135

Source page: https://510kreport.com/device/K844407
Methodology: https://510kreport.com/methodology