# K093346: BD Geneohm Mrsa Acp Assay

- Pathway: 510(k) (Traditional)
- Applicant: Bd Diagnostics (Geneohm Sciences, Inc.)
- Decided: Dec 15, 2009 after 50 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K850291 (1985). 5 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042357: Idi-Mrsa Assay, Infectio Diagnostic (I.D.I.), Inc. (2004) Summary page 1.
- K070462: Xpert Mrsa, Cepheid (2007) Summary page 1.

## Most influential descendants
- K120138: BD Max Mrsa Assay, BD Max Instrument (2012), 4 descendants of its own
- K133605: BD Max Mrsa XT, BD Max Instrument (2013), 2 descendants of its own
- K112937: Mrsa/SA Elite MGB (2012), 1 descendant of its own
- K191742: ARIES MRSA Assay (2019), 0 descendants of its own
- K162444: Xpert MRSA NxG (2016), 0 descendants of its own

## Recalls of this device
- May 22, 2012 · Class II · Z-2316-2012: Leakage in Cepheid SmartCycler reaction tubes.
- May 22, 2012 · Class II · Z-2317-2012: Leakage in Cepheid SmartCycler reaction tubes.

## Indications for use
The BID GeneOh M TM MRSA ACP Assay is a qualitative in vitro diagnostic test for the direct detection of methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patients at risk for nasal colonization. The test utilizes polymerase chain reaction (POR) for the amplification of MRSA DNA and fluorogenic target-specific hybridization probes for the detection of the amplified DNA. The BID GeneOh M TM MRSA ACP Assay is intended to aid in the prevention and control of MRSA infections in healthcare settings. It is not intended to diagnose MRSA infections nor to guide or monitor treatment for MRSA infections. Concomitant cultures are necessary only to recover organisms for epidemiological typing or for further susceptibility testing.

Source page: https://510kreport.com/device/K093346
Methodology: https://510kreport.com/methodology