# K851949: Staphaurex ZL30

- Pathway: 510(k) (Traditional)
- Applicant: Wellcome Diagnostics
- Decided: May 22, 1985 after 19 days
- Product code: GTN (Antisera, Fluorescent, All Types, Staphylococcus Spp.)
- Device class: 1
- Regulation: 21 CFR 866.3700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 4 cite it directly.
0 of 11 devices 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.

## Most influential descendants
- K071026: BD Geneohm Staphsr Assay (2007), 9 descendants of its own
- K082140: Xpert Mrsa/SA Blood Culture Assay (2008), 3 descendants of its own
- K101879: Xpert Mrsa/SA BC (Blood Culture) Assay Model Gxmrsa/SA-BC-10 (2010), 2 descendants of its own
- K130894: Xpert Mrsa/SA Blood Culture Assay; Genexpert DX Systems (GX-I, GX-II, GX-IV, GX-Xvi); Genexpert Infinity-48 System; Gene (2013), 1 descendant of its own
- K102342: Keypath (TM) Mrsa/Mssa Blood Culture Test- BT (2011), 1 descendant of its own

Source page: https://510kreport.com/device/K851949
Methodology: https://510kreport.com/methodology