# K132822: BD Max Staphsr Assay, Instrument

- Pathway: 510(k) (Traditional)
- Applicant: Geneohm Sciences Canada, Inc. (Bd Diagnostics)
- Decided: Nov 26, 2013 after 78 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: 5 generations back to K850291 (1985). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071026: BD Geneohm Staphsr Assay, Bd Diagnostics (Geneohm Sciences Canada, Inc) (2007) Summary page 1.
- K120138: BD Max Mrsa Assay, BD Max Instrument, Bd Diagnostics (Geneohm Sciences Canada, Inc) (2012) Summary page 1.

## Recalls of this device
- Jul 17, 2019 · Class II · Z-2333-2019: The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
- Jul 17, 2019 · Class II · Z-2332-2019: The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

## Indications for use
The BD MAX StaphSR assay performed on the BD MAX System is an automated qualitative in vitro diagnostic test for the direct detection and differentiation of Staphylococcus aureus (SA) and 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/SA DNA and fluorogenic target-specific hybridization probes for the detection of the amplified DNA. The BD MAX StaphSR assay is intended to aid in the prevention and control of MRSA and SA infections in healthcare settings. It is not intended to diagnose MRSA or SA infections nor guide or monitor treatment for MRSA/SA 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/K132822
Methodology: https://510kreport.com/methodology