# K120138: BD Max Mrsa Assay, BD Max Instrument

- Pathway: 510(k) (Traditional)
- Applicant: Bd Diagnostics (Geneohm Sciences Canada, Inc)
- Decided: Jul 5, 2012 after 170 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: 4 (0 Class I)
- 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.
4 later devices descend from it; 2 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)
- K093346: BD Geneohm Mrsa Acp Assay, Bd Diagnostics (Geneohm Sciences, Inc.) (2009) Summary page 1.

## Most influential descendants
- K133605: BD Max Mrsa XT, BD Max Instrument (2013), 2 descendants of its own
- K191742: ARIES MRSA Assay (2019), 0 descendants of its own
- K162444: Xpert MRSA NxG (2016), 0 descendants of its own
- K132822: BD Max Staphsr Assay, Instrument (2013), 0 descendants of its own

## Recalls of this device
- Sep 23, 2025 · Class II · Z-0238-2026: Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is 
- Oct 31, 2024 · Class II · Z-0590-2025: BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are 
- Jul 17, 2019 · Class II · Z-2328-2019: The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
- Jul 23, 2014 · Class II · Z-2618-2014: The performance of the assay no longer conforms to this statement in the Analytical Specificity section of the Package Insert: One hundred-eleven (111) out of 111 MSSA strains tested at extremely high

## Indications for use
The BD MAX™ MRSA Assay performed on the BD MAX™ System is an automated 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 real-time polymerase chain reaction (PCR) for the amplification of MRSA DNA and fluorogenic target-specific hybridization probes for the detection of the amplified DNA. The BD MAX™ MRSA Assay 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. A negative result does not preclude nasal colonization. Concomitant cultures are necessary to recover organisms for epidemiological typing or for further susceptibility testing.

Source page: https://510kreport.com/device/K120138
Methodology: https://510kreport.com/methodology