# K260041: MDx-Chex for BCP

- Pathway: 510(k) (Traditional)
- Applicant: Streck, LLC
- Decided: Mar 27, 2026 after 80 days
- Product code: PMN (Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays)
- Device class: 2
- Regulation: 21 CFR 866.3920
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to DEN150058 (2016). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231221: MDx-Chex for BC-GP, Streck (2023) Summary page 5.

## Indications for use
MDx-Chex for BCP is intended for use as an external positive and negative assayed control to monitor the performance of the qualitative detection of Gram-positive bacteria and associated antimicrobial resistance genes, by the Diasorin LIAISON PLEX Gram-Positive Blood Culture assay on the LIAISON PLEX System. The MDx-Chex BCP Positive and Negative Controls are composed of a buffered solution with stabilized erythrocytes and leukocytes in a matrix of blood culture media components. Positive Control: Gram-positive bacteria: Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Streptococcus agalactiae, Streptococcus anginosus group, Streptococcus pneumoniae, Streptococcus pyogenes, Enterococcus faecalis, Enterococcus faecium; genus: Bacillus spp., Listeria spp., Staphylococcus spp., Streptococcus spp.; antimicrobial resistance genes: mecA/mecC, vanA, and vanB. Negative Control: buffered solution only. This product is not intended to replace manufacturer controls provided with the device.

Source page: https://510kreport.com/device/K260041
Methodology: https://510kreport.com/methodology