# K190613: BD MAX Check-Points CPO

- Pathway: 510(k) (Traditional)
- Applicant: Check-Points Health B.V.
- Decided: Aug 29, 2019 after 171 days
- Product code: POC (System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, 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: 5 generations back to K972359 (1997). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160901: Xpert Carba-R, Cepheid (2016) Summary page 5.

## Indications for use
The BD MAX Check-Points CPO Assay performed on the BD MAX System is a qualitative, automated in vitro diagnostic real-time PCR test designed for the detection and differentiation of the carbapenemase genes blaKPC, blaNDM, blaVIM/blaIMP and blaOXA-48, that are associated with carbapenem non-susceptibility in Gram-negative bacteria. The assay does not distinguish between the blaVIM and blaIMP genes. The BD MAX Check-Points CPO Assay is intended as an aid to infection control in the detection of carbapenem-non-susceptible bacteria that colonize patients in healthcare settings. The BD MAX Check-Points CPO Assay is not intended to guide or monitor treatment for carbapenem-non-susceptible bacterial infections. A negative BD MAX Check-Points CPO Assay result does not preclude the presence of other resistance mechanisms. Testing is performed on rectal swabs from patients at risk for intestinal colonisation with carbapenem non-susceptible bacteria. This test is intended for use in conjunction with clinical presentation, laboratory findings, and epidemiological information. Results of this test should not be used as the sole basis for patient management decisions. Concomitant cultures are necessary to recover organisms for epidemiological typing, antimicrobial susceptibility testing, and for further confirmatory bacterial identification.

Source page: https://510kreport.com/device/K190613
Methodology: https://510kreport.com/methodology