# K112937: Mrsa/SA Elite MGB

- Pathway: 510(k) (Traditional)
- Applicant: Elitech
- Decided: Jun 1, 2012 after 242 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: 4 generations back to K850291 (1985). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093346: BD Geneohm Mrsa Acp Assay, Bd Diagnostics (Geneohm Sciences, Inc.) (2009) Summary page 1.

## Most influential descendants
- K132468: Mrsa/SA Elite MGB, Elite MGB Software (2013), 0 descendants of its own

## Indications for use
MRSA/SA ELITe MGB is a qualitative in vitro diagnostic test for the direct detection of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) using DNA purified from nasal swabs. MRSA/SA ELITe MGB is intended to aid in the prevention and control of MRSA infections in healthcare settings. It is not intended to diagnose, guide or monitor MRSA infections, or provide results of susceptibility to oxacillin/methicillin. A negative result does not preclude MRSA/SA (Staphylococcus aureus) nasal colonization. Concomitant cultures are necessary to recover organisms for epidemiological typing or for further susceptibility testing.

Source page: https://510kreport.com/device/K112937
Methodology: https://510kreport.com/methodology