# K071026: BD Geneohm Staphsr Assay

- Pathway: 510(k) (Traditional)
- Applicant: Bd Diagnostics (Geneohm Sciences Canada, Inc)
- Decided: Dec 20, 2007 after 253 days
- Product code: NQX (System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen)
- Device class: 2
- Regulation: 21 CFR 866.1640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K020322 (2002). 7 ancestors in all.
9 later devices descend from it; 5 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K851949: Staphaurex ZL30, Wellcome Diagnostics (1985) Summary page 1.
- K863821: Mueller Hinton Agar W/4%Nacl and Oxacillin, Gibco Laboratories Life Technologies, Inc. (1986) Summary page 2.
- K020322: BD Phoenix Automated Microbiology System, Becton, Dickinson & CO (2002) Summary page 2.
- K023301: BD Phoenix Automated Microbiology System, Becton, Dickinson & CO (2002) Summary page 1.
- K042357: Idi-Mrsa Assay, Infectio Diagnostic (I.D.I.), Inc. (2004) Summary page 1.

## Most influential descendants
- 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
- K080837: Xpert Mrsa/SA Ssti Assay (2008), 1 descendant of its own

## Indications for use
The BD GeneOhmTM StaphSR Assay is a qualitative in vitro diagnostic test for the rapid detection of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) directly from positive blood culture. The assay utilizes polymerase chain reaction (PCR) for the amplification of specific targets and fluorogenic target-specific hybridization probes for the real-time detection of the amplified DNA. The assay is performed on Gram positive cocci, identified by Gram stain, from positive blood cultures. The BD GeneOhmTM StaphSR Assay is not intended to monitor treatment for MRSA/SA infections. Subculturing of positive blood cultures is necessary for further susceptibility testing.

Source page: https://510kreport.com/device/K071026
Methodology: https://510kreport.com/methodology